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Item 1. Business

2026-03-19 compared with 2025-03-10 · 279 added, 1082 removed, 534 unchanged (72% of the section changed)

Business Overview

We are a leading global digital health company with a mission to power the behavior changes that drive better health.

We are a vertically integrated health intelligence platform with a mission to power the behavior changes that drive better health.

Unlike software-only digital health platforms, Dario owns the complete chain of value in chronic care management - connected FDA-cleared hardware devices that generate continuous physiological data, AI built on that proprietary data, and a behavior change and coaching layer validated through over 100 peer-reviewed clinical studies.

We are committed to transforming healthcare by delivering a comprehensive and highly engaging whole-person health platform, which enables us to create a future where healthy change is effortless and accessible to all.

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We have created our whole-person healthcare solution through both organic development and acquisitions of leading companies across several therapeutic areas.

As a digital health consolidation leader, we have acquired companies that have spent over a decade and nearly $525 million, in combination with our own investment, to develop and deliver the most engaging whole-person health platform in the market to empower individuals to achieve their optimal health through data-driven, precision artificial intelligence (“AI”) personalized care solutions that integrate the management of physical and mental health needs.

As a digital health consolidation leader, we have acquired companies that have spent over a decade and nearly $525 million, in combination with our own investment, to develop and deliver the most engaging whole-person health platform in the market to empower individuals to achieve their optimal health through data-driven, precision AI personalized care solutions that integrate the management of physical and mental health needs.

Leveraging advanced analytics, data-driven AI precision and personalization, a deep understanding of consumer behavior, user-centric technology, and a holistic approach, we provide tailored interventions that meet the unique needs of each user to deliver the health industry’s highest levels of user activation and sustained engagement.

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and we continue to operate in the D2C market in the U.S.

by providing our chronic condition management and patient engagement solutions across many different health conditions.

and select international markets by providing our chronic condition management and patient engagement solutions across many different health conditions.

In addition, we use the D2C market as an innovation laboratory to develop and test new features and benefits to ensure that these innovations meet our high engagement and outcomes standards before deploying them in the business-to-business (“B2B”) market.

From our D2C origins, Dario and Twill expanded into similar B2B market segments over the past seven years such that these market segments now represent three-fourths of our current revenues.

From our D2C origins, Dario and Twill expanded into similar B2B market segments over the past eight years such that these market segments now represent three-fourths of our current revenues.

These B2B market segments include medium-to-large employers, national and regional health plans, and global pharmaceutical companies.

Our medium-to-large employer market segment is focused on employers with over 1,000 employees and currently includes three of the five largest global technology companies and one of the two largest employers in the United States.

In total, we had 53 employer customers in 2024.

In total, we had 1 67 employer customers in 2025, up from 53 in 2024.

We seek to provide solutions to their employees that address the primary areas of health condition focus on by employers for meaningful costs savings that can deliver high and sustainable returns on investment, which can exceed 5:1.

In this market segment, we go to market through a direct sales force, consultants, brokers, and channel partners that sell our solutions to their health plan and employer customers.

During 2025, we experienced significant growth in our employer segment.

Year-to-date, we added 85 new accounts, surpassing our internal annual goal of 40 new accounts for 2025.

In the third quarter of 2025, we announced the addition of ten new self-insured employer contracts, including the largest employer client in our history, collectively representing approximately 107,000 covered lives.

All five programs launched during the second and third quarters of 2025 and include our full cardiometabolic suite for diabetes, hypertension, and prediabetes management.

In October 2025, we further expanded our employer footprint with the addition of six new employer clients across multiple industries, representing

tens of thousands of newly covered employees.

Several of these agreements incorporate milestone-based and value-based pricing frameworks that tie payments to member engagement and clinical outcomes, supporting our continued expansion of value-based digital health offerings.

Our health plan customers include five of the nation’s largest organizations where we provide our solutions to their members both nationally and regionally.

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How We Generate Revenue

All of our customers have an interest in value-based health outcomes and care and have begun to work with us to align various types of outcomes with innovative revenue models.

We differentiate ourselves versus our competitors by being willing to enter into risk-based agreements with performance guarantees that align the financial incentives with the employer, health plan, employee, plan member, and we deliver the best health outcomes at the most affordable price, thereby delivering the highest ROI.

Across all market segments, we follow a digital health engagement platform subscription revenue model that is priced upon either a per user population basis (“PMPM”) or a per engaged user basis (“PEMPM”), and in some cases a customer may employee both pricing options together.

These revenue models can also include milestone-based payments, as well as performance guarantees.

Our digital health platform subscription model applies across our various product and therapeutic areas of focus.

An increasing majority of our customers are focused on value-based health outcomes and are working with us to align outcomes-based contracts with innovative revenue models.

We differentiate ourselves by our willingness to enter into risk-based agreements with performance guarantees that align financial incentives across employers, health plans, employees, and plan members.

Our multi-condition digital health platform enables customers to address multiple conditions through a single integrated platform, reducing duplicative spending and lowering in-year investment with less out-of-pocket cost per member.

By managing co-morbid conditions within one platform, customers benefit from improved clinical outcomes, increased engagement, and incremental medical cost savings.

This integrated approach drives a higher return on investment by delivering measurable health improvements across multiple conditions while reducing both in-year program spend and overall medical costs.

As a result, we deliver more value per dollar spent, with lower actual in-year investment and greater return through clinical improvements and medical cost savings across a broad set of conditions.

Across all market segments, we operate a digital health engagement platform subscription model priced on either a per member per month (“PMPM”) basis or a per engaged member per month (“PEMPM”) basis, and in some cases, customers may utilize both pricing options.

These arrangements may also include milestone-based payments and performance guarantees.

Our subscription model applies consistently across our products and therapeutic areas.

We have the following product offerings with the engagement platform subscription revenue models:

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We find prevalence of mental health conditions to be around 20% among employer and health plan populations, and more than 50% among some pharmaceutical company therapeutic areas of focus.

Dario Health (Diabetes) – Combining our proprietary glucometer as well as our Dario Health digital self-care application and virtual coaching, Dario Health for diabetes delivers the highest level of A1c reduction among the leading digital health

companies focused on diabetes, of between 1.4 and 2.3 points, depending on the patients’ initial baseline.

Dario Health (Diabetes) – Combining our proprietary blood glucose meter as well as our Dario Health digital self-care application and virtual coaching, together with unlimited testing supplies, including strips and lancets, to eligible members.

Dario Health for diabetes delivers the highest level of A1c reduction among the leading digital health companies focused on diabetes, of between 1.4 and 2.3 points, depending on the patients’ initial baseline.

This is offered through both our D2C and B2B sales channels.

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Studies completed with a top 20 pharmaceutical company using claims data suggested total medical cost savings for patients using this solution reaching $5,000 per year.

Customers can pay for digital self-care and virtual coaching on either a PMPM or PEMPM basis.

Dario Health (Hypertension) – We include our own proprietary blood pressure cuff with our Digital Health self-care application and virtual coaching.

This is offered through both our D2C and B2B sales channels.

Dario Health (Hypertension) – We include our Digital Health self-care application, virtual coaching and our Dario branded blood pressure monitor and cuff, which is offered as a blood pressure monitoring system.

Clinical research has demonstrated that more than two-thirds of users with Hypertension stage 1 levels experience a 13mmHg reduction in systolic blood pressure when used as directed.

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This is offered through both our D2C and B2B sales channels.

Customers can pay for digital self-care and virtual coaching on either a PMPM or PEMPM basis.

Dario Health (Weight management and GLP-1) – 42.4% of the U.S.

population is overweight with about 30.7% being obese, meaning they have a body-mass index (“BMI”) of 30 or greater, creating the greatest level of prevalence among all of our product offerings.

The recent introduction of GLP-1 medication has also increased the interest in this solution.

We believe that we have demonstrated that our digital self-care solution, with our proprietary weight scale, Dario Health app and virtual coaching, delivers the industry’s highest level of digital self-care weight loss, at 10%, over 12 months.

By educating users and helping them change their diet, exercise, and sleep behaviors, users can keep the weight off.

We have modified our core offering to complement GLP-1 onboarding and offboarding, as well as GLP-1 prescription services.

We offer this through B2B sales channels.

Customers can pay for digital self-care and virtual coaching on either a PMPM or PEMPM basis.

In 2024, we provided our GLP-1 offering to 20% of our employer customers, and we expect this to increase due to the strong demand for GLP-1s among patients and employers.

Dario Move (MSK) – Pain is one of the primary reasons for employees missing work and it is one of the key drivers of healthcare costs.

Dario Move focuses on improving posture to alleviate pain with its proprietary medical device used with its Dario Move application and virtual coaching.

We believe that we have demonstrated that our digital self-care solution, with our Dario Health app and virtual coaching, delivers the industry’s highest level of digital self-care weight loss, at 10%, over 12 months.

By educating users and helping them build healthier lifestyle habits such as changing their diet, exercise, and improving sleep behaviors, the solution is designed to help users lose weight and maintain that weight loss over time.

Growing usage of GLP-1 medication has also increased interest in this solution.

We are seeing that the costs associated with GLP-1 medication wastage becoming a significant area of focus for employers who are now also leveraging our Dario weight management solution as both a required lifestyle behavior change partner and, in certain programs, as a requirement for access to GLP-1 prescriptions.

We have modified our core weight management offering to complement GLP-1 onboarding and offboarding, as well as GLP-1 prescription services, creating an integrated experience for members using GLP-1 medications.

We offer standard weight management and GLP-1 solutions through our B2B sales channel.

Dario Move (musculoskeletal, or “MSK”) – Pain is one of the primary reasons for employees missing work and it is one of the key drivers of healthcare costs.

Dario Move focuses on improving posture to help alleviate pain with its proprietary medical device used with its Dario Move application and virtual coaching.

We find that prevalence among employers is nearly 25%.

This solution is only sold on a B2B and D2C basis, and is generally combined with our other offerings, and can be paid for on either a PMPM or PEMPM basis.

Bundled Full-suite or Partial-suite – While any one of our solutions can be subscribed to individually, increasingly employers and health plans are seeking vendors who are no longer point solution providers but who can consolidate multiple condition offerings into a single offering with one simple price.

To accommodate these market demands, we now increasingly provides subscriptions for its full-suite or partial-suite on a PMPM or PEMPM basis, where additional clinical network services can be added on either a FFS basis or added to the PMPM or PEMPM subscription pricing.

As one of the only whole-person digital health companies with a full suite of cardiometabolic, behavioral health, and musculoskeletal solutions, we believe that we have a competitive advantage with our bundled offering.

Bundled Full-suite or Partial-suite – In response to market demand, we have evolved our commercial model to reduce contracting friction and administrative complexity associated with managing multiple point solutions.

Employers and health plans are increasingly seeking to simplify vendor contracting, implementation, data integration, audits, and quarterly business reviews, while prioritizing vendors that have demonstrated the ability to reduce total cost of care while delivering sustainable health improvements and a positive member experience.

To address these needs, we offer bundled subscriptions across our full-suite or partial-suite of solutions, enabling customers to consolidate multiple condition programs under a single contract and simplified pricing structure.

bundled offerings is typically on a PEMPM basis, which is increasingly preferred by customers as it places Dario at risk to drive meaningful member engagement and deliver desired clinical and economic outcomes.

From a member perspective, bundled offerings also simplify the experience by providing access to multiple programs through a single application, eliminating the need to enroll in and managing multiple separate programs.

Bundled subscriptions may also include additional Dario or partner clinical network services offered either on an FFS basis or incorporated into the subscription pricing.

While bundled offerings provide pricing and scale efficiencies, our individual condition solutions remain available for customers who prefer single-condition purchases.

As one of the few whole-person digital health platforms offering an integrated suite of cardiometabolic, behavioral health, and musculoskeletal solutions, we believe our ability to bundle services while preserving customer flexibility provides a competitive advantage.

Why We Have Confidence in Our Digital Offerings

We have developed a comprehensive body of research, encompassing over 100 studies, that have demonstrated the transformative potential of our digital health solutions in advancing clinical care.

We believe that these findings emphasize the platform’s ability to deliver long-term sustainable outcomes, including durable results over three years, while showcasing scalability with outcomes for more than 100,000 members.

We have established ourselves as a pioneer in the digital health sector, being the first to analyze multi-condition impacts by exploring relationships such as blood glucose and blood pressure, as well as blood glucose and weight monitoring.

Our research program is conducted under physician-led clinical governance, overseen by the Company’s Chief Medical Officer, to ensure rigor and consistency.

We believe that these findings emphasize the platform’s ability to deliver long-term sustainable outcomes, including durable results over four years, while showcasing scalability with outcomes for more than 1.2 million members.

Critically, the data underlying these studies comes from objective, continuous physiological measurements generated by Dario’s own connected devices - not self-reported inputs or app engagement proxies.

This distinction is fundamental:

Dario’s AI and clinical evidence base is trained on real-world clinical data that competitors without a decade of hardware deployment and clinical study cannot replicate.

Since our inception, we have established ourselves as a pioneer in the digital health sector, being the first to analyze multi-condition impacts by exploring relationships such as blood glucose and blood pressure, as well as blood glucose and weight monitoring.

This work spans diverse clinical domains, including diabetes, hypertension, weight loss, pain, depression, and anxiety.

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those with a baseline HbA1c greater than 9, with a 2.3-point reduction in HbA1c compared to a 1.8-point reduction among non-Dario users.

Additionally, our members achieved substantial cost savings of $5,077 per person annually, driven by reductions in all-cause healthcare resource utilization (“HCRU”) and office visit costs.

Additionally, our members achieved substantial cost savings of $5,077 per person annually, driven by reductions in all-cause healthcare resource utilization and office visit costs.

These outcomes are underpinned by the demonstrated effectiveness of behavioral engagement, which serves as a critical driver of improved clinical results.

Collectively, these achievements position us as a leader in digital health, delivering enhanced care and meaningful economic value.

The Company’s clinical research strategy, evidence standards, and outcomes reporting are directed by our Chief Medical Officer.

The following provides a summary of many of our clinical research findings that support our claims to improving user clinical, health, and economic outcomes.

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Competitive Strengths

Our competitive advantage has emerged from our founding roots as a D2C company, that required us to develop the most engaging self-care digital behavioral programs and medical devices.

Over more than a decade and over $500 million investment in technology, we have completed over 90 studies on the various whole-person health offerings to demonstrate their first-in-class clinical and health outcomes that results for a combination of high levels of sustained user engagement and highly effective clinically validated behavior change.

We expanded from our initial diabetes focus to now include hypertension, obesity, weight management, musculoskeletal pain, stress, anxiety, and depression, that are all offered from the same digital health platform and can be bundled together or sold individually.

By collecting billions of data points across all these health conditions over a decade, we have developed and commercialized it AI driven personalization that magnifies all of our competitive advantages to deliver more valuable results for users and customers.

Claim-based analysis of our users has shown that we generate the highest ROI for its customers, whether they be employers, health plans, or pharmaceutical companies.

Our competitive advantage stems from our origins as a D2C company, which requires us to build highly engaging self-care digital behavioral programs and integrated medical devices from the outset.

Over more than a decade and more than

$500 million invested in technology, we have completed over 100 clinical, real-world evidence studies (“RWE”), and outcomes studies across our whole-person health offerings, demonstrating first-in-class clinical and health outcomes driven by sustained user engagement and clinically validated behavior change.

From an initial focus on diabetes, we have expanded to include hypertension, obesity and weight management, musculoskeletal pain, stress, anxiety, and depression, all delivered through a single digital health platform that can be bundled or sold individually.

By collecting billions of data points across these conditions over more than ten years, we have developed and commercialized AI-driven personalization that amplifies our clinical and economic performance.

Claims-based analyses of our users demonstrate that we deliver among the highest ROI for customers, including employers, health plans, and pharmaceutical companies.

D2C Roots Ensured Highest Levels of Engagement

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Clinical Validation of The Highest Levels of Health Outcomes

Over more than a decade, we have completed over 90 randomized controlled trials (“RCTs”), real-world evidence studies (“RWE”), observational studies, interventional studies, and insurance-claims-based analysis.

Over more than a decade, we have completed over 100 studies, including randomized controlled trials (“RCTs”), RWEs, observational studies, interventional studies, and insurance-claims-based analysis.

These have demonstrated our ability to generate best-in-class clinical and economic outcomes.

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These include all areas of cardiometabolic health (e.g., diabetes, hypertension, overweight/obesity), behavioral health (e.g., stress, anxiety, and depression), and musculoskeletal pain.

In addition, we are partnering with clinical healthcare provides to provide virtual clinical care to its digital health offerings and virtual coaching.

By integrating all these onto its whole-person digital health platform, it enables a hyper personalized, seamless, and individualized experience across all relevant health needs that ensure high levels of user engagement to deliver robust clinical outcomes that exceed those of nearly all competitors across all medical conditions.

In addition, we are partnering with clinical healthcare providers to add virtual clinical care to our digital health offerings and virtual coaching.

By integrating all these onto our whole-person digital health platform, we enable a hyper personalized, seamless, and individualized experience across all relevant health needs that ensure high levels of user engagement to deliver robust clinical outcomes that exceed those of nearly all competitors across all medical conditions.

AI and Data-Driven Personalization

Our proprietary AI and machine learning algorithms deliver highly personalized health insights and interventions, ensuring relevance and efficacy for each user.

These were developed initially based upon our D2C experience with millions of users who pay out-of-pocket for our digital self-care solutions.

Our proprietary AI is not a product feature - it is the engine of our platform, trained on 13 billion proprietary data points generated by our own connected hardware devices over more than a decade.

Unlike AI built on publicly available or self-reported data, our models are grounded in longitudinal, condition-specific, clinical-grade data that grows more defensible with every new member enrolled and every new device deployed.

These algorithms were developed initially based upon our D2C experience with millions of users who pay out-of-pocket for our digital self-care solutions.

By leveraging billions of data points with our D2C offering, we optimize our user recruitment, activation, and engagement algorithms for first-in-class engagement.

Dario applies its AI, developed in the D2C market, to its B2B businesses to optimize the B2B businesses to enable Dario to outperform competitors in each market segment in engaging users and delivering valuable outcomes.

We apply our AI, developed in the D2C market, to our B2B businesses to optimize the B2B businesses to enable us to outperform competitors in each market segment in engaging users and delivering valuable outcomes.

The Industries Highest ROIs

We have done claims-based analysis of our various offerings with its customers to measure the medical and economic outcomes that results from using its whole-person digital health offerings.

We have done claims-based analysis of our various offerings with our customers to measure the clinical and economic outcomes that results from using our whole-person digital health offerings.

These studies support our claims for providing the digital health industry’s strongest ROIs by decreasing medical costs, increasing medication adherence, and activating and engagement users in the healthcare system more effectively than alternatives.

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We have four core growth strategies that leverage all aspects of our whole-person digital health platform.

After the acquisition of Twill in 2024 and integrating its commercial offerings and technological platform with ours, we are now prepared in 2025 to execute our growth strategies to both drive top line growth and to do so with greater operating efficiency that we believe will enable profitable growth.

After the acquisition of Twill in 2024 and integrating its commercial offerings and technological platform with ours, we are now prepared to execute our growth strategies to both drive top line growth and to do so with greater operating efficiency that we believe will enable profitable growth.

Dario Health Comprehensive Cardiometabolic Health

Our core offering is our Dario Health cardiometabolic suite that provides FDA cleared devices and a digital behavioral health experience that enables users to decrease the symptoms of hypertension, diabetes, and obesity.

Our primary market for this offering are medium-to-large sized employers that are seeking to control their chronic disease healthcare spending.

Our primary market for this offering is medium-to-large sized employers that are seeking to control their chronic disease healthcare spending.

We also work with large regional health plans to provide this offering to their members and self-insured employer customers.

We provide virtual coaching to all of these users and provides access to virtual clinical services to these users as well.

We find that among employees for most employers, the prevalence of diabetes is about 10%, while hypertension is 35%, and obesity and being overweight is between 35-75%.

Dario Connect is offered with Dario Health as a free digital experience that engages users across many different medical conditions.

We provide virtual coaching to all of these users and provide access to virtual clinical services to these users as well.

We find that among employees of most employers, the prevalence of diabetes is about 10%, while hypertension is 35%, and obesity and being overweight is between 35-75%.

Dario Connect is offered with Dario Health as a free digital experience that engages users across many different medical conditions within large health plan environments.

Users of Dario Connect participate in digital communities to learn more about their health condition, treatment options, learn from healthcare experts, including clinicians, and explore ways that they can improve their overall health.

Dario Connect acts as a gateway and digital front door to get access to all of our whole-person digital offerings, as well as to get access to our customer products and services.

Among employer customers, Dario Connect is how non-employee dependent learn about health care benefits they have access to and can access those benefits.

Dario Connect can act as a gateway and digital front door to get access to all of our whole-person digital offerings, as well as to get access to our customer products and services.

Users can also get access to our virtual clinic partners and services through Dario Connect.

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We have expanded our Dario Mind offering to include not only the industry leading self-care digital mental health application to decrease the symptoms of stress, anxiety, and depression, but also to provide access to virtual coaching, and virtual clinical services including virtual therapy and virtual clinical consultations, prescribing, and medication management.

We are the only provider in the market with a comprehensive whole-person digital health offering supported by RCTs that demonstrate the clinical efficacy of its digital cognitive behavioral therapy (“CBT”) and mindfulness interventions.

These clinical programs and outcome strategies are developed and overseen under the leadership of our Chief Medical Officer.

This offering has been deployed globally in 10 different languages among some of the world’s largest employers and health plans.

We find that among most of our employer clients, over 20% will have a meaningful mental health challenge that require some level of treatment and support that Dario Mind can provide.

We find that among most of our employer clients, over 20% will have a meaningful mental health challenge that requires some level of treatment and support that Dario Mind can provide.

In addition, we have several large pharmaceutical companies that provide Dario Mind to patients to address their comorbid stress, anxiety, and depression associated with their underlying medical condition.

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We offer the most comprehensive whole-person digital health offering in the market and can offer it as a bundled full-suite offering to employers and health plans where these customers can pay for the full bundle under any one of several revenue models such as PMPM, PEMPM, and milestone value-based.

This full suite bundle includes Dario Mind, Dario Health, Dario Connect, and Dario Move.

When pricing the full bundle, we price this based upon expected prevalence, engagement, outcomes for each component of the full bundle.

By so doing, we believe that we can achieve meaningful economies of scale related cost savings that it can pass on to our customers and thereby deliver industry leading ROIs.

All clinical programs within this bundled offering operate under our medical governance and clinical oversight.

This full suite bundle includes Dario Mind, Dario Health, and Dario Move.

When pricing a bundle, we consider condition prevalence and the size of the eligible population, recognizing that the average member uses approximately 2.4 Dario programs at a time.

As a result, we effectively charge for a single program while delivering more than twice the program value, with corresponding clinical improvements and downstream medical cost savings that directly delivers in-year return on Dario investment for the customer.

GLP-1 Opportunities with Employers and Pharmaceutical Companies

According to the Center for Disease Control (the “CDC”), 42.4% of Americans meet the BMI level of 30 for an obesity diagnosis.

According to the Center for Disease Control, 41.9% of Americans meet the BMI level of 30 for an obesity diagnosis.

In the past few years, pharmaceutical companies like Eli Lilly and Novo Nordisk have launched expensive, blockbuster GLP-1 drugs for patient who have been diagnosed as obese that have demonstrated the ability to decrease BMI by 10-20%.

Due to the success of these drugs in decreasing BMI, there are now nearly 100 drugs in the pipeline among these two pharmaceutical companies and their competitors that address many of the side effects that these drugs have with regards to tolerability, fatigue, and muscle loss.

Research indicates that 26.2% of patients discontinue GLP-1s at 3 months, with an additional 30.8 doing so at 6 mots, and 36.5% at 12 months;

Clinical appropriateness, tolerability, and patient safety guide our GLP-1 support strategy.

GLP-1 therapies initially entered the market as self-injections, which created a barrier to use for patients who were reluctant to self-inject.

However, the FDA’s December 2025 approval of Novo Nordisk’s once-daily oral Wegovy (semaglutide) has helped reduce this barrier.

Research indicates that 26.2% of patients discontinue GLP-1s at 3 months, with an additional 30.8 doing so at 6 months, and 36.5% at 12 months;

with only 25% remaining on the medication after two years.

Once a patient discontinues use of the GLP-1, the typical patient regained two-thirds of their weight within one year.

For this reason, employers are eager to have their employees engaged in an effective digital behavioral health program while they are on a GLP-1 that will in crease their weight loss while on the medication and keep the weight off after discontinuation by helping the patient develop new, sustainable healthy habits.

Presently, 20% of our employer customers now subscribe to its GLP-1 offering, and we see this as an important growth engine in the future.

We have also found interest among pharmaceutical companies in providing our GLP-1 solution so support patients on their medication in developing healthy habits to improve outcomes.

For this reason, employers are eager to have their employees engaged in an effective digital behavioral health program while they are on a GLP-1 that will increase their weight loss while on the medication and keep the weight off after discontinuation by helping the patient develop new, sustainable healthy habits and manage side effects.

Along with offering behavior change support, Dario launched its first eligibility client and its adherence offering that balances cost controls with enhanced rigor around ensuring GLP-1 program participants complete behavior change activities most correlated to weight loss within its program to access initial GLP-1 prescriptions and in some cases to ensure ongoing adherence to program activities.

Presently, an increasing number of our employer customers now subscribe to its GLP-1 offering, and we see this as an important growth engine in the future.

We have also found interest among pharmaceutical companies in providing our GLP-1 solution to support patients on their medication in developing healthy habits to improve outcomes.

Dario Flywheel Integrates All These Growth Strategies

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More B2B Clients:

condition and cross client monetization, such as from behavior health to cardiometabolic health, which increases the average revenue per user, and then increases the D2C users and value.

By getting more B2B customers it increases the number of users on the platform, which increases the data collected and used, increases the value to third-party and inhouse virtual clinical care networks, increases cross condition and cross client monetization, such as from behavior health to cardiometabolic health, which increases the average revenue per user.

User come from both our B2B and D2C market strategies, which drives our data driven innovation, and our value to virtual human care services.

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Dario AI Creating a Hyper-personalized Digital Health Future

We are successfully integrating AI to enhance patient care, streamline operations, and drive continuous innovation on its whole-person digital health platform.

We are successfully integrating AI to enhance patient care, streamline operations, and drive continuous innovation on our whole-person digital health platform.

Our mission has been to empower individuals with personalized, data-driven health solutions while continuously improving clinical outcomes and healthcare efficiency.

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Data and AI as a Strategic Asset

We, along with Twill (formerly a standalone entity before being acquired by us), has built an extensive repository of health data over a cumulative 25 years.

We have built an extensive repository of health data over a cumulative 25 years.

This wealth of information serves as a critical asset, fueling AI-driven insights that enhance decision-making, predict health risks, and optimize patient engagement.

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● Multi-condition focus:

Addressing multiple therapeutic areas Cardiometabolic (diabetes, hypertension, weight management), Behavioral Health (stress, anxiety, depression), and musculoskeletal pain with over 75 million physical and behavioral health measurements collected through our medical devices and tens of billions of data points through its applications.

● Uniquely matched datasets:

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Enabling integration with client-provided care modalities, seamlessly connecting them to Dario’s digital care pathways.

Our AI strategy has three primary pillars:

Operational Efficiency and Simplification :

Optimizing workflows, reducing administrative burdens, and enhancing operational efficiency to drive better healthcare outcomes.

Whole-Person Patient Care :

Expanding our product offerings to provide the most comprehensive and personalized care experience for every individual from digital self-care to virtual clinical care.

Curated generative AI :

Leveraging a cumulative 25 years of proprietary data collection and content creation to develop a unique generative AI model tailored to personalized care in a highly regulated healthcare environment.

Recent advancements in AI model training, particularly in reducing hardware costs, serve as a significant accelerator for Dario’s curated generative AI.

These developments enable us to scale and refine our AI models more efficiently, further enhancing predictive accuracy and real-time personalization.

Operational Efficiency and Simplification

Our AI has been instrumental in improving operational efficiency across multiple functions, enhancing productivity, automating routine tasks, and optimizing decision-making processes.

Specific applications include:

• High-Quality Content Creation :

AI-driven tools assist in generating engaging, evidence-based health content, improving efficiency and consistency.

• Culturally Adapted Content Translation :

Custom trained generative AI models based on our vast content library in more than 10 languages enable automatic translation of new content that maintains a consistent tone of voice and cultural sensitivities across all languages.

• Software Development :

AI accelerates software development by optimizing code generation, debugging, and deployment processes.

• Member Services :

Deploy AI-powered automation to optimize member engagement, enhance customer support, improve response times and member satisfaction.

• Product Management :

Enables data-driven product decisions, enhancing usability and personalization.

• Human Resources (HR) :

Improve recruitment, employee engagement, and workforce planning, streamlining HR processes.

Optimize financial operations, forecasting, and risk management, reducing manual efforts and improving accuracy.

• Internal Knowledge Retrieval :

Retrieval-Augmented Generation (“RAG”) used to facilitate seamless access to organizational knowledge, enabling employees to quickly find relevant data, policies, and historical insights for improved decision-making and efficiency.

Our AI development and adoption is enabling us to reduce operating expenses.

Looking ahead, we expect ongoing AI advancements to drive an additional efficiency gains in the next few years, further reducing costs and improving user experience, customer service, innovation, and value.

Curated Generative AI

We are pioneering a proprietary generative AI model today, which delivers highly personalized care solutions in a tightly regulated healthcare environment.

Our advancements in AI model training reduce hardware dependency and costs and further accelerate the scalability and performance of curated generative AI.

RAG represents a key component of this model that enhances generative AI by integrating real-time, domain-specific proprietary data retrieval, which represents a proprietary advantage.

• Context-Aware Generative AI – Our RAG engine enhances AI-generated content by incorporating the latest medical insights, ensuring accuracy and relevance.

• Unique and Certified Data - Unlike generic GenAI models relying on publicly available internet data, our generative AI is built upon a unique, healthcare-intelligent, and certified dataset.

• Healthcare-Specific Intelligence – Our generative AI integrates domain-specific knowledge, ensuring high accuracy and contextual relevance for patient care applications.

• Regulatory Compliance – We designed our RAG to adhere to strict healthcare regulations.

As such, we supports safe, ethical, and privacy-compliant AI-driven health solutions.

• Commitment to Ethical AI - We prioritize fairness, transparency, and ethical AI development in all our models.

• Regulatory Adherence - Our AI systems comply with healthcare regulations, including Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the EU General Data Protection Regulation (“GDPR”), ensuring data security and patient privacy.

• Bias Mitigation - Continuous refinement of AI models help minimize bias, improving accuracy and equitable healthcare delivery.

• Patient Trust - AI systems are built with patient trust in mind, ensuring that AI-driven insights enhance rather than replace clinical decision-making.

Whole-Person Patient Care

Our AI-powered solutions enhance patient engagement, provide predictive analytics, and deliver personalized treatment plans.

AI applications in patient care include:

• Personalized Digital Therapeutics :

AI-powered algorithms tailor interventions based on individual health data, improving adherence and engagement.

• Predictive Analytics for Chronic Disease Management :

Our predictive model for blood glucose levels demonstrates over 90% accuracy, which can support efforts to guide user behaviors to engage in timely interventions and proactive treatment in cases where early warning signs can ameliorate health deterioration.

• Automated Coaching and Behavioral Insights :

AI-driven behavioral coaching adapts to users in real-time, enhancing self-management and lifestyle modifications.

• Clinical Decision Support :

AI enhances provider decision-making by surfacing actionable insights based upon algorithms that are based upon vast data sources that enhance clinical judgments.

• Recommendation Engine Optimization :

AI-driven recommendation systems refine patient treatment strategies, enhance engagement and improve health outcomes.

Capabilities and Applications

We deliver measurable commercial value by leveraging AI-driven personalization, human expertise, and connected devices to engage users and drive sustained behavior change across the conditions that matter most to its customers, including diabetes, hypertension, weight management, behavioral health, and musculoskeletal health.

We have developed, and made strategic technology acquisitions to enhance, a suite of AI-driven capabilities that leverage years of implementation experience and the Company’s native data assets to support personalized digital health solutions.

These capabilities are deployed across Dario’s platform and support member engagement, content delivery, clinical insights, and operational efficiency.

In the fourth quarter of 2025, we enhanced our digital health platform with DarioIQ, a proprietary AI layer that is intended to support more personalized and efficient member experiences across our solutions.

DarioIQ has been initially introduced within our D2C offerings in order to evaluate safety, performance, and member response in a controlled environment before making the capability more broadly available to our B2B customers as an optional feature.

DarioIQ is designed as a clinically aligned, conversational layer that operates alongside our existing data- and experience-driven applications.

The system is intended to interpret member data, surface relevant insights, and support more tailored guidance while working in coordination with our human-centered care model rather than replacing it.

Over time, we expect DarioIQ to be integrated more deeply across our portfolio of chronic condition solutions as we validate additional use cases.

The DarioIQ platform incorporates multiple AI-driven components that are designed to deliver member-facing support, maintain engagement, and generate decision-support insights for our customers.

These components are built on proprietary and curated healthcare-intelligent data assets and are developed within our existing privacy, security, and compliance framework, including processes intended to align with applicable healthcare data protection regulations.

Key elements of the DarioIQ architecture include:

● Advisor – a member-facing component intended to provide personalized guidance and educational support based on an individual’s profile and interactions.

● Sentinel – an engagement layer designed to identify appropriate moments for outreach and surface timely prompts to help maintain member participation.

● Strategist – an analytics and decision-support layer that aggregates member-level information to generate insights and value measures for our customers.

In addition, we have developed DarioSHIFT, an operations initiative focused on using AI agents and tools and agentic AI capabilities to improve the efficiency and scalability of our business operations.

DarioSHIFT is intended to support functions such as sales development, member services, software development and responses to requests for proposals by automating routine tasks, optimizing workflows and accelerating certain development activities.

DarioSHIFT has already successfully deployed several AI tools and is currently expanding deployment of AI agents across multiple use cases, including sales development representative optimization, member services optimization, developer tools and RFP response support.

Early use cases have shown a positive impact on how AI agents take on repeatable, process-driven activities so that our teams can focus on higher value and more complex work.

These early-stage learnings are intended to inform how we may redesign workflows, staffing models and support technology over time.

In addition, we already have several agents in regular use with demonstrative impacts, particularly within software development workflows, such as an AI-enabled scrum master agent that evaluates user stories against defined quality criteria and surfaces recommendations automatically, which we believe will contribute to increased developer velocity and more efficient use of resources over time.

To help manage the risks associated with AI deployment, we are developing DarioSHIFT under the oversight of a Center of Excellence intended to promote safe, scalable and compliant implementation of AI capabilities across the organization.

This governance model is designed to align AI-related initiatives with our existing data privacy, security, clinical quality and compliance frameworks, and to provide a structure through which new use cases can be evaluated before broader adoption.

As with all forward-looking initiatives, there can be no assurance that DarioSHIFT will achieve its intended benefits, and we expect to continue iterating on its design as we gain additional experience.

On Dario’s AI Roadmap

In 2025, we plan to widen and deepen its utilization of AI in the following four areas:

• GLP-1 optimization :

Utilize AI-powered models to predict members’ level of adherence to GLP-1 prescription prior to prescribing and their level of success in maintaining outcomes post GLP-1 off-boarding.

This capability will allow Dario to intelligently prioritize prescriptions over other weight loss and behavior change programs.

• Advancing RAG -powered Generative AI:

Refining AI-driven personalized healthcare by integrating real-time monitoring, improving predictive accuracy, and adapting models to personalized treatment plans.

Leveraging reinforcement learning enables continuous AI improvements based on patient feedback and outcomes.

• Operational Efficiency and Simplification :

We have several productivity initiatives in multiple areas such as Product Management, Member Services, and Human Resources.

Looking ahead to 2026, we plan to continue the rollout of DarioIQ through a phased, risk-managed roadmap.

We expect to broaden availability within our D2C offerings, explore additional condition areas, and initiate targeted deployments with select employer and health plan customers, subject to ongoing evaluation of safety, performance, and customer needs.

In parallel, we intend to refine DarioIQ’s capabilities, safeguards, and integration points across our platform as we gather additional operational experience, clinical and engagement data, and stakeholder feedback.

We will also continue to mature DarioSHIFT with the meaningful usage and deployment of AI agents and tools and monitor the impact on operational costs and revenue ratios.

We operate in a highly competitive digital health market, characterized by rapid innovation and evolving consumer expectations.

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The first dimension is an increased focus on ROI driving by economies of scale.

Recent surveys of employer’s priorities indicates that they want digital health solutions that have much lower costs that can be broadly deployed among their populations and deliver much higher ROIs than they have accepted in the past.

Recent surveys of employer’s priorities indicate that they want digital health solutions that have much lower costs that can be broadly deployed among their populations and deliver much higher ROIs than they have accepted in the past.

A 2:1 ROI is no longer adequate to meet the needs of employers and health plans.

For this reason, we have leveraged our AI investments, superior user engagement, highly effective user behavior change, and access to virtual digital care and services to deliver the highest ROIs in the industry that generally exceed 5:1.

The second dimension is driven by economies of scope that increases simplicity by decreasing the number of digital health vendor that deliver an increasingly broad scope of digital health offerings.

As AI capabilities become more broadly available, we believe the primary competitive differentiator will be the quality and proprietary depth of the underlying data - not the software layer itself.

Our hardware-generated, longitudinal clinical dataset represents a structural advantage that pure software platforms cannot replicate through technology investment alone.

The second dimension is driven by economies of scope that increases simplicity by decreasing the number of digital health vendors that deliver an increasingly broad scope of digital health offerings.

This simplifies contracting, reporting, value creation, access to users, and the creation of value for users, employers, and health plans.

With these two emerging value creation dimensions that are driving competitive advantage, we see the following companies as its primary competitors:

With these two emerging value creation dimensions that are driving competitive advantage, we see the following companies as their primary competitors:

Broad-based Digital Health Platforms

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(a division of Teladoc), Calm.com, Inc., and Talkspace, Inc., compete in the B2B behavioral health marketplace.

All these companies focus narrowly on behavioral health with no plans to expand their scope to include additional chronic disease conditions.

All these companies primarily focus narrowly on behavioral health rather than multi-condition support.

Wearable Technology Firm

While we integrate with many wearable technology firm’s devices from companies such as Fitbit, Garmin, and Apple, these companies also provide some D2C offerings that could be considered as competitors to our D2C products.

However, these companies do not truly compete in the B2B employer, health plan, and pharmaceutical marketplace with

competitive comprehensive behavioral and cardiometabolic offerings.

However, these companies do not truly compete in the B2B employer, health plan, and pharmaceutical marketplace with competitive comprehensive behavioral and cardiometabolic offerings.

As such, we do not see these companies are true competitors.

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The same is generally true for most health plans, which primarily focus on vendors like us to provide chronic and behavioral health solutions to their members.

Given this competitive landscape, we differentiate ourself through our integrated whole-person health approach, AI and data-driven personalization, and commitment to user-centric design to deliver industry leading levels of sustained user engagement.

Given this competitive landscape, we differentiate ourselves through our integrated whole-person health approach, AI and data-driven personalization, and commitment to user-centric design to deliver industry leading levels of sustained user engagement.

Our focus on measurable outcomes and strong partnerships positions us as a leader in the digital health market that can deliver the economies of scale and scope that delivers the highest ROI and easiest delivery of its individual or bundled solutions.

Recent Developments

In the first quarter of 2024, we launched the Aetna behavioral platform with approximately a dozen customers, whereby we began to generate revenue from that collaboration, and we expect Aetna to continue to add employers to the platform.

A separate self-help program contracted with Aetna last year launched on the platform at the end of the first quarter and is also expected to grow throughout 2024.

Employer Contracts

In April 2024, we announced four new contracts to provide integrated chronic condition management solutions for two employers beginning in the second quarter of 2024.

In November 2024, we announced the signing of four contracts with self-insured employers that are expected to go live in the first quarter of 2025.

The contracts span across the full suite of our platform, with no one opting for a single condition, showing evidence of the value of a multi-condition offering.

Presentation of New Studies

In March 2024, we announced two new clinical studies presented at the International Conference on Advanced Technologies and Treatments for Diabetes (ATTD) 2024, demonstrating a 6.38% reduction in weight for members with a baseline BMI of 30 and above and an overall reduction in blood glucose levels, with average blood glucose levels remaining below 140 mg/dL for one year.

In April 2024, we announced two new studies published in the leading peer-reviewed journal for digital health and medicine, Journal of Internet Medicine (JMIR), including a Randomized Controlled Trial (RCT) demonstrating the impact of a digital stress reduction program for teens.

In April 2024, we announced new research published in the leading peer-reviewed journal for digital health and medicine, JMIR, demonstrating a clinically significant reduction in blood glucose levels for members using Dario to manage weight alongside diabetes.

GLP-1 Updates

In June 2024, we announced a new contract with a national employer to provide its cardiometabolic solution with integrated support for GLP-1s to employees beginning in the third quarter of 2024.

In June 2024, we presented two studies presented at the 84th Annual American Diabetes Association (ADA) Scientific Sessions in Orlando.

The first study provides an analysis of member data for those tracking a GLP-1 medication

in Dario's cardiometabolic solution.

A retrospective analysis was conducted using data from members using Dario to manage Type 2 diabetes or prediabetes and taking either Metformin, a standard medication prescribed for diabetes, or a GLP-1.

Both member groups were tracked for 12 months as they engaged with our digital chronic condition solution to measure blood glucose levels and track lifestyle activities such as diet and exercise.

Members also utilized our Medication Cabinet feature to log Metformin or GLP-1 dataset reminders and report adherence.

The data showed significant improvement in adopting healthy behaviors over a 12-month period across both groups as shown by increased tracking of healthy lifestyle behaviors as shown by logged meals and physical activity beginning in the first three months and sustained through the 12-month period.

Additional research presented by us at the ADA conference examined Dario's ability to help members realize the goal of diabetes remission for people living with Type 2 diabetes.

The ADA considers remission to be achieve when an individual with Type 2 diabetes sustains normal blood glucose levels of less than 6.5% HbA1c for three months without the aid of a diabetic medication.1 This retrospective study analyzed the data of 7,240 individuals with Type 2 diabetes using our platform to help manage their condition without the help of insulin for at least six months.

The results demonstrated a significant impact:

● 31% of our members experienced blood glucose levels reflecting the goal of diabetes remission with average blood glucose readings of less than 140 mg/dL (A1c 6.5%) during a three-month period;

● 70% of our members achieved a blood glucose level of less than 140 mg/dL in their last month of usage maintained it for three-month period, indicating behavior change and improved long-term glycemic control;

● Lifestyle activities as shown by logged meals and physical activity moderated the reduction in average blood glucose levels and high readings ratio.

New Research Reveals How Physical Activity Mediates the Impact of Depression on Blood Glucose Levels in Individuals with Diabetes or Prediabetes

In September 2024, we announced the publication of a new study in the peer-reviewed journal Frontiers in Endocrinology.

The study demonstrates the effectiveness of our cardiometabolic solution for members living with diabetes or prediabetes and depression.

Integration of Twill Behavioral Health Capabilities into Cardiometabolic Health Solution

In September 2024, we announced the integration of condition-specific communities and peer groups with personalized navigation capabilities into our cardiometabolic solution to improve outcomes-based engagement, marking a significant milestone in the integration of the Dario-Twill product offering.

Twill by Dario to Offer a Benefit for AARP Members

In October 2024, we announced a new AARP member benefit that provides members with proven digital behavioral health and well-being solutions from Twill by Dario.

The new benefit is expected to launch in January of 2025 for AARP members.

Integration of Twill Capabilities Across Full Multi-Condition Platform

In October 2024, we announced the full integration of Twill's advanced behavioral health and navigation capabilities into our platform.

The integration completed our effort to create one of the most comprehensive and effective end-to-end digital health solutions in the market.

By unifying data across mental and physical health, we offer a more personalized and effective approach to care.

New Regional Health Plan, Expanding Reach in Medicaid Population

In October 2024, we announced a new contract with a regional health plan in the Medicaid space, which has launched with the full suite of cardiometabolic solutions.

Starting with an initial pilot program, we will work closely with the health plan to bring its proven solutions to the plan's population, which includes nearly 10,000 Medicaid members.

Pharma Collaborations with Global Pharma Leader to Enhance User Engagement

In November 2024, we announced a new collaboration with a pharma company that will utilize Dario Connect (formerly Twill Care) among their patient populations to further their direct-to-consumer efforts using our refined engagement and navigation technologies.

In an effort to strengthen and expand connections across patient populations that are candidates for a new drug to treat psoriasis, a top pharmaceutical company chose us to pilot a cutting-edge initiative aimed to help onboard patients that will engage with the drug via the platform.

This collaboration is designed to collect critical insights on patient outcomes and drug effectiveness, with Dario Connect's innovative community-building capabilities playing a key role in enhancing patient engagement.

GLP-1 Solution with Prescribing Capabilities through Collaboration with MediOrbis LLC, Targeting Employers and Direct-to-Consumer Markets

In January 2025, we announced a collaboration with MediOrbis, a multi-specialty digital health provider, to add prescribing capabilities to our GLP-1 behavior change solution for a comprehensive medical weight loss program.

This strategic addition creates a fully integrated solution for employers covering weight-loss medications and supports direct-to-consumer offerings, expanding our addressable market in one of the fastest-growing segments of digital health.

On November 26, 2024, we were notified of the termination of the Amended and Restated Exclusive Preferred Partner, Co-Promotion, Development and License Agreement with Sanofi U.S.

Services Inc.

(“Sanofi”), dated July 10, 2023, which was originally executed on February 28, 2022.

On December 4, 2024, we transitioned our relationship with Sanofi and entered into a services agreement.

Pursuant to the services agreement, we will configure our Twill Care platform for Sanofi and transition the relationship to a recuring revenue model.

In March 2025, we announced a strategic collaboration with Path CCM, Inc.

d/b/a Rula Health ("Rula”), a leading provider of high-quality behavioral health services, to expand access to mental health support for employers and their workforce nationwide.

Through this strategic collaboration, we will have exposure to Rula’s extensive network of over 15,000 providers.

By leveraging Rula’s high-quality provider network with extensive coverage, we will offer an “easy button” solution for employers looking to implement behavioral health support seamlessly within their existing benefits structure.

Strategic Review Following Multiple Unsolicited Inbound Expressions of Interest

On September 25, 2025, we announced that our board of directors has initiated a comprehensive strategic review to maximize shareholder value following multiple unsolicited inbound strategic inquiries from interested parties.

In relation to this review, our board of directors has established a special committee (the "Special Committee") of independent directors and engaged Perella Weinberg Partners LP as financial advisor.

The Special Committee will consider a full range of potential opportunities including a sale, merger, strategic business combination, or continued execution of our strategy.

Strategic Collaboration to Enhance Fall Risk Prevention and Mobility Insights

On October 6, 2025, we announced a strategic collaboration with OneStep, a FDA-listed digital health company that delivers clinical-grade gait and mobility analysis using only smartphones.

The collaboration expands our multi-condition digital health platform with advanced fall-risk assessment and prevention capabilities designed to support high-risk populations, including individuals with obesity and Medicare Advantage members experiencing frailty and balance challenges.

Clinical Studies

Main Highlights

Our studies below demonstrate the clinical value of our legacy digital therapeutic devices and the ability of our solutions to deliver sustainable outcomes over time.

At the ADA 2018 session, Dario presented three real-world-data analysis studies, as detailed below.

Type 2 Diabetes Users of Dario Digital Diabetes Management System Experience a Shift from Greater than 180 mg/dL to Normal Glucose Levels with Sustainable Results

● Reduction of 19.3% in high glucose readings within 12 months

● Increase of 11.3% in in-range readings within 12 months

A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of all active Type 2 Diabetic (T2D) users that took measurements with Dario TM Blood Glucose Monitoring System (“BGMS”) on average of 20 measurements per month during 2017.

The study assessed the ratio of all high blood glucose readings (180-400 mg/dL) and the ratio of all normal blood glucose readings (80-120 mg/dL) in their first month of use to their last month of use during 2017 as recorded in the database.

For 17,156 T2D users activated during 2017 the average ratio of high events (180-400 mg/dL) was reduced by 19.3% (from 28.4% to 22.9% of the entire measurements).

While at the same time, the ratio of normal range readings (80-120 mg/dL) was increased by 11.3% (from 25.6% to 28.5% of the entire measurements).

Updated Analysis combining 2017 and 2018 data totals 38,838 Type 2 Diabetes active users and 3,318,014 measurements show 14.3% decrease in high readings (180-400 mg/dL) and 9.2 % increase in In-range (80-120 mg/dL) readings.

A decrease in High Readings and Severe Hyperglycemic Events for People with T2D over the Full Year of 2017 in Users Monitoring with Dario Digital Diabetes Management System

● Reduction of 20% of High events (180-400 mg/dL) in T2D sustained within 12 months

● Reduction of 58% of Hyper events (>400mg/dL) in T2D within 12 months

A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of active T2D users that continuously measured their blood glucose using Dario TM BGMS during the full year of 2017 was evaluated.

The study assessed the ratio of high (180-400 mg/dL) and hyperglycemic (>400mg/dL) blood glucose readings during full year of 2017 as recorded in the database.

The average of high and hyperglycemic glucose readings were calculated in periods of 30-60, 60-90, 90-120, 120-150, 150-180, 180-210, 210-240, 240-270, 270-300, 300-330, 330-360 days and compared to first 30 days as a starting point of analysis.

For 225 T2D active users the ratio of high events (180-400 mg/dL) was reduced gradually in 19.6% (from 23.4% to 18.8% of the entire measurements) from baseline compared to the 12 th month of the year.

Moreover, the ratio of severe hyperglycemia events (>400 mg/dL) was decreased in 57.8% (from 0.90% to 0.38% of the entire measurements) at the same period.

Continuous Reduction of Blood Glucose Average during One Year of Glucose Monitoring Using Dario Digital Monitoring System in a High-Risk Population

● The study presented a reduction of 14% Blood Glucose average was observed in T2D within 12 months

● 76% of the population showed 24% improvement in Blood glucose average within 12 months

An exploratory data analysis study reviewed a population of high-risk active type 2 Diabetic users with initial 30 days glucose average above 180 mg/dL during a full calendar year.

The study assessed the average blood glucose readings along a year of usage.

The average glucose readings was calculated per user in periods of 30 days intervals from 30-60 to 330-360 days and compared to the first 30 days as the starting point baseline of analysis.

Overall of 238 highly engaged T2D users (more than one daily measurement in average) whose average blood glucose level was above 180mg/dL in the first 30 days of measurements (225±45 mg/dL) showed continuous reduction in glucose level average vs.

Reduction in blood glucose average level was demonstrated gradually, in the succeeding 3, 6 and 12 months showing average decrease of 7%, 11% and 14% vs.

baseline, respectively.

Furthermore, 76% of the entire population (180 out of 238 users) improved their average blood glucose level over a year.

Those 180 users (average blood glucose 228±46) showed an average decrease of 10%, 16% and 24% in their glucose average following 3, 6 and 12 months, respectively.

At the American Association of Diabetes Educators (AADE) 2018 Dario presented a study titled “Decrease in Estimated A1C for people in High-risk over a full year of users monitoring with a digital Diabetes management system.”

A reduction of 1.4% in estimated HbA1C in Type 2 Diabetes high risk users from baseline after one year of the Dario system use.

A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of high-risk (with baseline A1C > 7.5 percent), active users that continuously measured their blood glucose using Dario TM BGMS during a full year was evaluated.

The study assessed estimated A1C values based on blood glucose readings during a full year as recorded in the database.

The estimated A1C values were calculated in periods of 3, 6, 9 and 12 months and compared to first 30 days as a starting point of analysis.

A group of 363 high-risk Dario BGMS users (A1C>7.5) with greater than two blood glucose measurements taken per day in the first 30 days and in the 12 th month of the year was selected.

Estimated A1C was improved by -0.7, -0.8 and -1 percent from baseline to 3, 6 and 9 months respectively, and remained -1 percent lower following 12 months of usage (8.65±0.96 vs.7.65±1.0).

Moreover, subgroup analyses by diabetes type revealed substantial estimated A1C improvement among people with T2D showing improvement of -1 percent from baseline to 3, 6 months and 1.4 percent following 12 months (8.5 ± 0.91% vs.

7.14% ± 0.98%).

An additional study evaluated the potential improvement in glycemic variability in Type 2 diabetes over six months in patients monitoring with Dario Digital Diabetes Management System.

Dario presented the study results at the Advance Technologies and Treatment for Diabetes (ATTD) conference in February 2019 in Berlin.

We presented two additional studies outcomes at ADA 2019 conference.

Decrease in Glycemic Variability for T2D over Six Months in Patients Monitoring with Dario Digital Diabetes Management System

● The study demonstrated a reduction of 14%-18% in measurements variability was observed in T2D within 6 months

● Hypo events (<70 mg/dL) remained <1 event on average

A retrospective data evaluation study was performed on the Dario TM database.

A population of T2D high-risk patients (blood glucose measurements average (GM avg ) >180 mg/dL) measuring more than 20 times in the first 30 days (analysis baseline) was evaluated on days 60-90 (3 months) and 150-180 days (6 months).

Standard deviation (SD) and GM avg were calculated and compared to the baseline.

A group of 698 T2D high-risk Dario TM users was selected.

GV was reduced by 10% and 14% from baseline through 3 and 6 months, respectively (SD of 55.7, 58.4 vs.65.0).

GM avg was reduced by 8% and 12% from baseline through 3 and 6 months, respectively (201.1±25.57, 192.8±54.3 vs.

219.5±38.5) while patient’s hypoglycemic event (<70mg/dL) was in average, less than one (<1) during this period.

Subgroup analyses (355 patients) revealed substantial

GV improvement among non-Insulin T2D patients.

The GV was reduced by 14% and 18% from baseline through 3 and 6 months, respectively (SD of 52.8, 50.7 vs.61.7).

T2D Users of Dario Digital Diabetes Management System Experience an Increase of in-range Glucose Levels Linked to App Engagement

Relative Increase of 10 % In-range linked to App engagement

A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of active T2D users (>15 measurements per month on average) was evaluated.

The study assessed the ratio of in-range blood glucose readings (70-140 mg/dL) as a function of App engagement level for 6 months as recorded in the database compared to first 30 days as a starting point of analysis.

A population of 4917 T2D non-insulin users measuring more than 15 times per month on average during 6 months in a row was evaluated.

The ratio of in-range (70-140 mg/dL) readings was increased following 3 months in correlation to the level of tagging meal reference/carbs/physical activity occurrences (4.0%, 9.1% and 11.9% for tagging 0-1, 1-2 and >2 times per day on average, respectively) and sustained for 6 months.

Reduction of Blood Glucose Average Less than 140mg/dL in People with Type2 Diabetes Using Dario Digital Diabetes Management System

30-40% of T2D Dario users experienced Reduction of Blood Glucose Average below 140 mg/dL

A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of active T2D users that continuously measured for 6 months was evaluated.

The study assessed their BG avg and estimated A1C (eA1C) values based on blood glucose readings as recorded in the database.

Values were calculated in periods of 3 and 6 months and compared to their first 30 days as a starting point analysis.

A group of 1248 Dario BGMS T2D active users (1.98 measurements per day on average during 6 months in a row) with BG avg >140mg/dL (eA1C>6.5) was evaluated.

All 1248 (100%) reduced their BG avg along 6 months on average.

A group of 31% (387) achieved BG avg of <140 mg/dL (eA1C<6.5) following 3 months showing 19% reduction on average from baseline (132.38±13.36 vs.162.79±25.41 mg/dL and eA1C 6.24±0.46 vs 7.3±0.88) and sustained their glycemic control during a 6 month period (131.57±13.86 mg/dL and eA1C 6.21±0.48).

Subgroup analyses of 568 non-insulin users revealed that 40% (226) achieved a BG avg <140 mg/dL following 3 months (131.95±13.21 vs.161.67±24.18 mg/dL and eA1C 6.22±0.46 vs 7.26±0.84) and sustained for 6 months period (131.03±13.70 mg/dL and eA1C 6.19±0.47).

Along the 6 months period, hypo events (<50mg/dL) per user per month on average remained stable.

In August 2019 another study was presented at the AADE 2019 in Atlanta.

The study evaluated the “Impact of Digital Intervention on In-range Glucose Levels in Users with Diabetes.” The study results showed 6% improvement in average blood glucose levels over 3 months intervention program for a group of 162 users.

A 39% increase in the in-range (80-130 mg/dL;

<180mg/dL post-meal) measurements was observed in a subgroup of 101 patients who started with average blood glucose levels of over 140mg/dL.

In November 2019, another analysis was presented in Diabetes Technology conference “The Effect of Digital Intervention on Glycemic Control in Users with Diabetes” looking on total in-range measurements ratio 70-180 mg/dL showing increase of 19% following 3 months on the Dario Engage platform.

In February 2020, we presented an additional clinical study at the ATTD conference in Madrid, Spain.

The presented data shows the Dario digital therapeutics platform successfully assists insulin dependent patients with diabetes in reducing hypoglycemic events.

Decrease in Hypoglycemia Events Over Two Years in Patients Monitoring with Dario’s Digital Diabetes Management System

A retrospective data analysis was performed on the Dario real-world database.

Insulin dependent of users with type 1 or type 2 diabetes population was evaluated for two years of continuous system use.

Average numbers of level 1 hypoglycemia (<70mg/dL) and level 2 hypoglycemia (<54 mg/dL) events were calculated monthly and compared to baseline (first month).

For 1481 type 1 and type 2 insulin dependent users, average of level 1 hypoglycemia events and level 2 were reduced by 24% and by 17% after 6 months and by 50% and 57% after 2 years vs.

baseline respectively.

Users with type 1 diabetes (N=363) reduced level 1 hypoglycemia events by 50% and Level 2 by 55% after 2 years.

Moreover, a 40% reduction in high blood glucose readings was observed as well after 2 years.

In June 2020, we presented two clinical studies at the ADA virtual conference.

The presented data from these studies showed:

Estimated A1C Reduction in High-Risk Patients Over Two Years of Using a Digital Diabetes Management Platform

This study presented data indicated the potential for a digital diabetes management solution to effect and sustain glycemic control improvements and demonstrated long term reduction of blood glucose average (eA1c) and glycemic variability in type 2 diabetes over two years.

The system assists users through a variety of mechanisms including behavior modification in diabetes self-management and in long-term routines for self-care.

A retrospective study of high-risk users (BG avg >180 mg/dL equivalent to e A1c 8.0) 2 with type 2 diabetes that measured their blood glucose using the Dario® platform database over two consecutive years was performed.

The minimum engagement level for inclusion was at least two blood glucose measurements per day on average taken in Month 1 and Month 24.

Actual blood glucose readings were taken by the Dario meter and loaded into the cloud database.

These were evaluated for the blood glucose average (“BGavg”), estimated A1c (eA1c) values and glycemic variability (by Standard Deviation;

SD) following 24 months compared to the first month (baseline).

368 high-risk, T2D active and engaged users for at least consecutive 2 years were identified and assessed for their risk-level and insulin usage.

A group of 148 T2D, non-Insulin users that started with a blood glucose average (BG avg) >180 mg/dl (equivalent to eA1c>8.0) consistently reduced their BG avg by 18% on average and sustained these values (179±45 vs.

219±56 mg/dL) following 2 years on the Dario platform.

Glycemic variability was reduced over two years by 20% on average (SD:45 vs.

Substantial reductions were observed for higher risk groups (insulin and non-insulin treated).

The subset that started with average BG levels > 212 mg/dL (eA1c >9.0) and average BG levels >240 mg/dL (eA1c>10) reduced their average BG by 22.5% and 25.7% respectively on average over two years.

The equivalent reductions in eA1c were 1.95% and 2.42%.

Users with type 2 diabetes using a digital platform experienced sustained improvement in blood glucose levels.

A retrospective data evaluation (Q1:2018-2019) was performed on the Dario ® data base.

A population of active users (18 measurements per month with the Dario ® System on average) with T2D, non-Insulin treated was evaluated over a full year.

High blood glucose readings (180-400 mg/dL, >250 mg/dL), fasting readings (<126 mg/dL) and post-meal readings (<180mg/dL) ratios were assessed in their first month of use until the 12 th month.

For 9,200 users with T2D, non-Insulin users, the average ratio of high glycemia events (180-400 mg/dL) from entire set of measurements was reduced by 26% (18.62% vs.

23.43%) while readings of >250mg/dL were reduced by 33% (4.65% vs.

6.93%) over a year.

Fasting measurements analysis revealed an increase of 16% in ratios of readings <126 mg/dL per entire set of fasting measurements (40.59% vs.

34.92%) on average.

In August 2020, we presented an additional clinical study at the Virtual Association of Diabetes Care and Education Specialists (ADCES) conference.

The presented observational study data demonstrated better glycemic and blood pressure control.

Patients using an integrated chronic disease management digital platform have the potential to improve user activation which may assist to better manage their blood glucose and blood pressure levels and sustain behavioral change.

Impact of Digital Management on Clinical Outcome in Patients with Chronic Conditions:

diabetes and hypertension.

The study presented Hypertension and Diabetes clinical outcomes.

Hypertension:

Increase in normal level % measurements from 6% to 12% while hypertension stage 2 measurements decreased from 53% to 45%.

70% of the users (243 out of 345) improved their blood pressure levels by 8.4 mmHg Systolic and 6.2 mmHg Diastolic, on average.

Glucose levels:

A reduction of 33% in high readings (>250 mg/dL) and 67% in severe events (>400 mg/dL) was observed over six months .

A retrospective data evaluation study was performed on the Dario TM cloud database.

A population of active users that measured both blood pressure and blood glucose for at least 3 months was observed.

Blood pressure and blood glucose levels were evaluated.

First month measuring on Dario platform was used as study baseline.

Clinical outcomes examined were blood pressure values, percentage of blood pressure categories, BGavg and high blood glucose readings (>250 mg/dL, >400 mg/dL) ratios.

A group of 345 active users started at baseline with Hypertension stage 1, 2 or hypertensive crisis levels and measured following 3 months was evaluated.

● Blood pressure outcomes:

o Normal levels increased from 6% to 12% and percentage of users with hypertension stage 2 decreased from 53% to 45%

o 70% of the users (243 out of 345) improved their blood pressure levels in 8.4 mmHg Systolic and 6.2 mmHg on average (Systolic 134.2±12 vs.142.6±14;

Diastolic 89.9 ±11 vs.83.7 ±8.7)

● Blood Glucose outcomes:

o A group of 345 users measured with Dario their blood glucose in addition to blood pressure, 89% are type 2 and pre-diabetes - average age is 60.4.

o For the group of 345 users a reduction of 33% (5.4% vs.8.0%) in high readings ratio (>250 mg/dL) and 67% (0.3%vs.0.9%) in severe events ratio (>400 mg/dL) was observed following six months on average.

A subset of 114 users with diabetes in higher risk started with BG average >160 mg/dL improved their average blood glucose by 14% (207±47 vs.177±50 mg/dL) following six months compared to baseline.

In November 2020, we presented additional clinical study data at the Virtual Diabetes Technology Society (“DTS”) meeting.

The Effect of a Digital Therapeutic Platform on Glycemic Control in Adults above Age 65 with Type 2 Diabetes.

This study showed reduction of 13% blood glucose average in age group ≥65 (N=298) at six months sustained for 12 months, and reduction of 38.1% in high readings ratio (>250 mg/dL) in the ≥65 age group at six months and by 41.5% at 12 months.

In February 2021 we published in the first time in a peer-reviewed journal “ Journal of Medical Internet research (JMIR) Diabetes”, the article:

“Role of Digital Engagement in Diabetes Care Beyond Measurement:

Retrospective Cohort Study”

This study sheds light on the source of the association between user engagement with a diabetes tracking app and the clinical condition, highlighting the importance of within-person changes versus between-person differences.

Our findings underscore the need for and provide a basis for a personalized approach to digital health.

This retrospective real-world analysis followed 998 people with type 2 diabetes who regularly tracked their blood glucose levels with the Dario digital therapeutics platform for chronic diseases.

Subjects included “nontaggers” (users who rarely or never used app features to notice and track mealtime, food, exercise, mood, and location, n=585) and “taggers” (users who used these features, n=413) representing increased digital engagement.

Within- and between-person variabilities in tagging behavior were disaggregated to reveal the association between tagging behavior and blood glucose levels.

The associations between an individual’s tagging behavior in a given month and the monthly average blood glucose level in the following month were analyzed for quasicausal effects.

A generalized mixed piecewise statistical framework was applied throughout.

Analysis revealed significant improvement in the monthly average blood glucose level during the first 6 months ( t =−10.01, P <.001), which was maintained during the following 6 months ( t =−1.54, P =.12).

Moreover, taggers demonstrated a significantly steeper improvement in the initial period relative to nontaggers ( t =2.15, P =.03).

Additional findings included a within-user quasicausal nonlinear link between tagging behavior and glucose control improvement with a 1-month lag.

More specifically, increased tagging behavior in any given month resulted in a 43% improvement in glucose levels in the next month up to a person-specific average in tagging intensity ( t =−11.02, P <.001).

Above that within-person mean level of digital engagement, glucose levels remained stable but did not show additional improvement with increased tagging ( t =0.82, P =.41).

When assessed alongside within-person effects, between-person changes in tagging behavior were not associated with changes in monthly average glucose levels ( t =1.30, P =.20).

In February 2021, we also presented two studies virtually in ATTD.

Impact of a Digital Intervention Engine on Diabetes Self-management

A digital diabetes platform has the potential to consistently interact with users, improve self-management and sustain among users who had not recently measured their blood glucose.

A retrospective study was performed on a population of 246 Dario active members who had not measured blood glucose for a 7-day period.

127 of these users were randomly assigned to a Test group and experienced a digital intervention flow, and the remaining 119 users were assigned to a Control group.

Digital engagement levels were observed following 60 days in both groups.

Differences between Test group and Control group were observed.

In the Test group, the percent of users who measured blood glucose was significantly higher (P<0.001):

14% in first 30 days and 22% in 30-60 days;

average number of measurements was 6% higher in the first 30 days and 17% in 30-60 days;

number of interactions (e.g.

logging fasting glucose) with the digital platform was 10% higher in first 30 days and 15% in 30-60 days.

Difference in average days between measurements, defined as “recency” was 30% lower in the test group.

Impact of a Digital Therapeutic on Insulin Self-Management

The potential benefit of a digital diabetes management platform in the self-management required from insulin treated users, incorporating its use on a daily base, and sustaining behavioral change.

A retrospective study was performed on a population of 285 active Dario users (85% with type 2) under insulin therapy, that measured with Dario for at least three months and logged basal insulin usage.

The group included 112 users whose starting average blood glucose >180 mg/dL.

Among this group the average age was 50±20.8.

The group also included 173 users whose starting average blood glucose was <180 mg/dL with average age 54±19.9.

First month measuring on platform was used as study baseline.

In the sub-group of 112 users the average amount of basal insulin increased by six units after three months (45 vs.39).

Their fasting blood glucose was significantly reduced (9%) after three months (186±57 vs.

204±62) without change in hypoglycemia events ratio (<70 mg/dL) on average, and 15% of the users reduced their fasting average to <126 mg/dL.

However, in the sub-group of 173 users, basal insulin usage and fasting glucose levels remained stable following three months.

In May 2021, a prospective pilot study was published in a peer reviewed journal “Journal of Diabetes Science and Technology”:

“Digital Therapeutics for Type 2 Diabetes:

Incorporating Coaching Support and Validating Digital Monitoring”

The study suggests that a diabetes digital platform with real-time feedback and access to coaching improved diabetes outcome measures such as HbA1c with a reduction in GV.

Importantly, we provide clinical validation for digital self-monitoring to deliver personalized care for patients with type 2 diabetes mellitus (“T2DM”).

Future research should replicate our findings using a larger sample.

In this study (ClinicalTrials.gov:

NCT04057248), 12 participants with baseline HbA1c >8.5% were provided with Dario digital therapeutic platform (connected blood glucose meter, test strips, mobile app and access to live certified diabetes care and education specialist (“CDCES”)).

At both study enrollment and completion, participants completed blood testing and a satisfaction report.

During 3-month intervention, participants tracked their blood glucose levels through the app and were routinely contacted by CDCES.

Clinical outcomes and self reported data before and after intervention were compared.

● Significant reduction in lab values such as HbA1C (2 points), Fasting Blood Glucose (18%) and BMI (10%)

● Statistically significant improvement in glucose variability (21%)

● Significant improvement in self-reported evaluation in weight and glucose control satisfaction

● Weekly engagement with CDCES predicted reduction of participants’ GV during the following week

In June 2021, two studies were presented in 81 th ADA:

Impact of Digital Intervention Tools on Engagement and Glycemic Outcomes

Product updates to digital platforms that guide on healthy eating and help users understand their glucose readings in context may assist users in improving the management of their diabetes.

A retrospective data evaluation study was performed on Dario TM members during the time before and after product modification.

Digital engagement and clinical outcomes were measured on first to six months per each period to examine if habit formation was achieved.

A group of total 9794 users who had enrolled in a membership for 6 months or longer was evaluated.

The digital engagement was improved.

The ratio of measurements logged with context (fasting, pre-meal, post-meal, bedtime) was increased significantly by 56% in the first month following product modification on average (51.3%.

32.8%) (P<0.001).

Differences in the level of digital engagement remained stable over a 6-month period.

The average number of days between measurements, i.e.

“recency” decreased by 21% on average (2.71 vs.

Average ratios of high readings (180-400 mg/dL) were reduced by 12% on average over six months.

Users with high-risk type 2 diabetes using a digital therapeutic platform experience a change in blood glucose levels

Digital diabetes platform has the potential to enhance self-care behaviors across socioeconomic statuses and among different language speakers.

A retrospective data evaluation study was performed on the Dario TM data base.

A population (“high-risk users”) of all users with type 2 diabetes activated during 2017-2020 who took measurements with Dario in the first 2 months and who started with an average blood glucose above 180 mg/dL was evaluated.

The ratios assessed were target range (70-180 mg/dL) and high blood glucose (>180 mg/dL) readings over a year.

Socioeconomic status was matched by applying zip code data to census.gov data.

For 11,101 users, the average ratio of target range readings (70-180 mg/dL) was significantly increased from 28.4% to 54.8% (P<0.001).

Average high events ratio (>180 mg/dL) was significantly reduced from 71.3% to 44.4% over a full year usage (P<0.001).

The change appeared in the earliest months and was maintained over a year.

Average number of days between measurements, i.e., “recency” was 3.3 days.

A subset of Spanish language app users (N=169) was also evaluated, and comparable trends were observed.

Matching Census.gov data on study population showed that 20% of users resided in low-income zip codes, 70% in middle and 10% in upper income zip codes.

In August 2021, we presented additional clinical study data at the ADCES meeting.

Efficacy of a tailored digital intervention tool targeting patients with clustered recurrent high glucose readings

The potential benefit of implementing a real-time digital diabetes intervention journey to recognize episodes of high blood glucose measurement clusters and assist patients in improving self-management and clinical outcomes.

A retrospective data evaluation study was performed on a population of 3,609 users who experienced a cluster event of frequent high blood glucose levels above 250 mg/dL (>=4 times in 4 different days along 7 days) and measured with Dario at least one month before and after the event during 2021.

A group of 1,084 users was assigned to a Test group who experienced a digital intervention flow with personalized messages via various channels.

The remaining 2,525 users were assigned to a Control group.

The clinical outcome examined was the monthly average of high blood glucose readings ratio calculated as the number of blood glucose measurements >250 mg/dL per total number of measurements in a month.

This was measured during the event month and in the following month.

T-test was used to compare the changes in high readings ratio in the Test group and Control group in the following month versus event month.

A significant difference of 19% vs.

control group (N=3,609), 18% for the group with type 2 (N=2307) and 42% for the group with type 2 non-insulin, in the reduction in average monthly ratio of high readings (above 250 mg/dL) per total blood glucose measurements in the following month.

The results indicate personalized communications are effectively influencing positive lifestyle behavior change

A group of 454 users experienced the cluster event in a 6-month period before the digital journey was activated and after.

A significant difference was observed after the digital journey versus before the digital journey in the following month’s change in high readings ratio (-8% vs.

P-value <0.03)

In February 2022, another manuscript was published in “ Journal of Medical Internet research (JMIR)”

“Blood Pressure Monitoring as a Digital Health Tool for Improving Diabetes Clinical Outcomes:

Retrospective Real-world Study”

The results of this study shed light on the association between BG and BP levels and on the role of BP self-monitoring in diabetes management.

Our findings also underscore the need and provide a basis for a comprehensive approach to understanding the mechanism of BP regulation associated with BG.

In this retrospective, real-world case-control study, we extracted the data of 269 people with T2D who tracked their BG levels using the Dario digital platform for a chronic condition.

We analyzed the digital data of the users who, in addition to BG, monitored their BP using the same app (BP-monitoring [BPM] group, n=137) 6 months before and after starting their BP monitoring.

Propensity score matching established a control group, no blood pressure monitoring (NBPM, n=132), matched on demographic and baseline clinical measures to the BPM group.

A piecewise mixed model was used for analyzing the time trajectories of BG, BP, and their lagged association

Analysis revealed a significant difference in BG time trajectories associated with BP monitoring in BPM and NBPM groups ( t =–2.12, P =.03).

The BPM group demonstrated BG reduction improvement in the monthly average BG levels during the first 6 months ( t =–3.57, P <.001), while BG did not change for the NBPM group ( t =0.39, P =.70).

Both groups showed similarly stable BG time trajectories (B=0.98, t =1.16, P =.25) before starting the use of the BP-monitoring system.

In addition, the BPM group showed a significant reduction in systolic ( t =–6.42, P <.001) and diastolic ( t =–

4.80, P <.001) BP during the first 6 months of BP monitoring.

Finally, BG levels were positively associated with systolic (B=0.24, t =2.77, P =.001) and diastolic (B=0.30, t =2.41, P =.02) BP.

In February 2022, we presented virtually in ATTD:

Impact of a digital therapeutic platform on weight loss and diabetes self-management

This observational study demonstrates the potential for digital platforms to durably improve diabetes and weight self-management among users with BMI of ≥30 kg/m 2 .

A retrospective study was performed on 715 Dario active members who started with a baseline BMI of ≥30 kg/m 2 (51% male;

80% with type 2 diabetes) and who recorded weight measurements for at least 12 months.

Weight measurements and blood glucose readings were observed over 12 months.

The total population of 715 users who participated in the study improved their weight level on average (p<0.05).

Nearly two-thirds of the population improved their weight, with an average reduction of 7.4% (p<0.05) and an average reduction in BMI of 2.8 kg/m 2 .

Over 30 percent achieved weight loss of 5% or greater over 12 months.

A subset of 237 engaged users who started with BMI of ≥35 kg/m 2 achieved weight loss of 5% over 12 months (p<0.05).

The subgroup of 108 users that started at high-risk blood glucose levels (average blood glucose >180 mg/dL) reduced their weight by 4.9%, average blood glucose by 16.1% and high readings ratio by 38% over 12 months (p<0.05).

In June 2022, three retrospective data analysis studies were presented in 82 th ADA:

Persons with high-risk diabetes, depression and stress using a Digital health platform experience improvement in glycemic management

The use of a multi-condition digital therapeutic platform may be associated with improved glucose management for persons with “high risk” glycemia who cope with depression and stress.

The present study revealed that a digital multi-condition platform has the potential to enhance self-care behaviors among people with diabetes that suffer from stress and depression.

A retrospective data analysis on the Dario TM database of users who activated the mobile app during 2019-2021 and who self-reported stress and depression in the app questionnaire.

Participants who took at least 5 measurements during their 1 st and 12 th months with Dario and who started with an average blood glucose >180 mg/dL were termed “high-risk”.

A statistical analysis (T-test) was used to evaluate the differences in average blood glucose and high blood glucose (>180 mg/dL) readings ratio over a year.

The high-risk group of 491 users significantly reduced their average blood glucose by 13% (204±60 vs.

234±55) (P<0.001).

A subset of high-risk users with type 2 (N=379) was also evaluated and significantly reduced their average blood glucose by 14% (P<0.001) (201±66 vs.

Moreover, high glucose events ratio (>180 mg/dL) was significantly reduced from 72 .6% to 55.8% over a full year of usage (P<0.001) (N=343).

Hypertension control among persons with diabetes using a self-management multicondition digital platform

A multi-condition digital therapeutic platform may promote behavioral modifications and result in sustainable improvements in both glycemic control and blood pressure levels.

The study demonstrates an improvement in multiple chronic conditions (diabetes and hypertension) for people using one digital platform.

A retrospective data evaluation was performed on the Dario database.

A population of active users who started with hypertension stage 1 (Systolic ≥130 mmHg or Diastolic ≥ 80mmHg) as their baseline since 2019 was identified.

Blood glucose and blood pressure readings were assessed at first and sixth month of use.

A subgroup of users who started at hypertension stage 2 was evaluated as well.

A statistical analysis (T-test) was used to evaluate differences in Systolic and Diastolic pressures and average blood glucose.

For the 2554 users with diabetes and hypertension stage 1 and above, more than two thirds improved their systolic blood pressure by 13 mmHg (P<0.001;

144±14 to 131±13) and diastolic blood pressure by 8 mmHg (P<0.001;

91±12 to 83±10) over six months.

Additionally, a group of 38.7% (N=990) moved to a lower hypertensive stage (P<0.001) according to American Heart Association definitions.

The subset of 1367 users with stage 2 hypertension improved their systolic blood pressure from 150±12.4 to 141±15.2 mmHg on average and 43.9% (N=600) improved their blood pressure by more than 10 mmHg over six months (P<0.001).

The subgroup of 306 users who started at high-risk blood glucose levels significantly reduced their blood glucose average by 15% over 6 months (232.4±46 to 198±65 mg/dL) (P<0.001).

Blood Glucose Levels in High-Risk Type 2 Diabetes Users of a Digital Therapeutic Platform by Race/Ethnicity

Digital therapeutic platforms may promote behavior modification in high-risk patients with type 2 diabetes to create sustainable outcomes and allow the users to become more active participants in their chronic condition.

The study revealed that the digital diabetes platform has the potential to enhance self-care behaviors across diverse populations.

A retrospective data study was performed on the Dario database.

A group of Dario digital therapeutic users with type 2 diabetes that was active during 2019-2021 and took at least three blood glucose measurements in the first and 12 th months was evaluated.

The group started with average blood glucose above 180 mg/dL in the first month and reported Ethnicity in the app:

White, Latino, Black, or Asian.

The baseline was defined as the first month’s average blood glucose.

A statistical analysis (Wilcoxon and Kruskal – Wallis tests) was used to evaluate the difference between groups in their average blood glucose levels over a year.

A group of 1,000 users was analyzed, male 483 (48%) and female 517 (52%) .

Average blood glucose was significantly reduced in all users and per ethnic group over a year:

All users by 14% (230±58 vs.

197±47) (p<0.001);

White by 14% (229±58 vs.

197±47) ) (p<0.001);

Latino by 15% (237±59 vs.

202±48) (p<0.001);

Black by 15% (230±63 vs.

196±48) (p<0.001) and Asian by 15% (229±55 vs.195±43) (p<0.005).

No difference between the groups was found at 12th month(P=0.751).

In August 2022, we presented a retrospective data analysis study in the ADCES.

Digital therapeutic platforms improve blood glucose management across rural/nonrural groups.

The study supports the hypothesis that digital diabetes platforms have the potential to enhance self-care behaviors across challenging population from varied socioeconomic statuses in high-risk patients with T2DM.

A retrospective data study was performed on the Dario database.

A group of T2DM “high-risk” users started with an average blood glucose of 180 mg/dL and above in the first month (baseline), was evaluated.

The group of Dario users were active at 2019-2021 and took at least six blood glucose measurements in the first, 6 th and 12 th months.

Members residency was defined as rural or nonrural based on whether their community was eligible to apply for Rural Health Grants by the Federal Office of Rural Health Policy (“FORHP”) (10).

Nonparametric tests were used to evaluate the differences in average blood glucose levels over a year.

● A group of 1333 users was analyzed with demographic characteristics as follows:

Nonrural 1157 (87%) and Rural 176 (13%).

● The blood glucose average mg/dl was significantly reduced (Friedman tests) in all users and in each rural/nonrural group over a year:

Nonrural reduced by 17% from T 0 to T 12 (228±59 vs.

190±47) (P<0.001);

Rural reduced by 13% from T 0 to T 12 (224±60 vs.

196±51) (P<0.001).

● No significant difference between Rural/Nonrural groups was found at first, 6 th and 12 th months periods (Kruskal-Wallis, P=0.235/0.163/0.142 respectively).

In August 2022, we published in the first-time two retrospective data analysis on behavioral health outcomes, Depression and Anxiety in the American Psychology Association (the “APA”).

Effectiveness of a Digital Behavioral Health Solution for Depression Symptoms

This study provides preliminary insights into the effectiveness of a digital chronic condition platform to facilitate symptom reduction in individuals screened for depression.

A retrospective data evaluation study was performed on the Dario database.

The Patient Health Questionnaire-9 (“PHQ-9”) was utilized to screen for depression severity and track progress over time.

The current sample is based on individuals who used the Dario Behavioral Health platform between 2019-2021, and completed at least two PHQ-9 assessments, one at baseline and the second between baseline and 12 weeks of platform utilization.

Scores were calculated based on PHQ-9 scoring guidelines.

Users were stratified based on severity as minimal-mild (score 0-9), mild-moderate and severe-moderate (10-19), or Severe (>=20).

A group of 496 platform users (376 women, 108 men, 12 other) who completed two assessments of PHQ-9 was evaluated.

The population included 269 users who started at minimal-mild severity and 227 who started at moderate or severe severity (175 moderate;

52 severe).The minimal-mild group mostly maintained at the same level of average PHQ-9 score post assessment.

The moderate-severe group significantly improved their average PHQ-9 score (P<0.001).

A proportion of 72% of moderate-severe users showed improvement in their post PHQ-9 assessment and 38% of moderate-severe users reported scores in the minimal-mild range over the study period.

Moreover, 44% of the moderate-severe population experienced a clinically significant score reduction (reduction of >5) in the full PHQ-9 over the study period.

Out of 175 users who started at a moderate depression level, and 162 (93%) improved or maintained their level and out of 52 users who started at a severe depression level, 30 (58%) users reduced their level to moderate or minimal-mild.

Effectiveness of a Digital Behavioral Health Solution for Anxiety Symptoms

This study provides preliminary insights into the effectiveness of a digital chronic condition platform to facilitate symptom reduction in individuals screened for anxiety.

A retrospective data evaluation study was performed on the Dario database.

The Generalized Anxiety Disorder Assessment (GAD-7) was utilized to screen for anxiety severity and track progress over time.

The current sample is based on individuals who used the Dario Behavioral Health platform between 2019-2021, and completed at least two GAD-7 assessments, one at baseline and the second between baseline and 12 weeks of platform utilization.

Scores were calculated based on GAD-7 scoring guidelines.

Users were stratified based on severity as minimal-mild (score 0-9), moderate (10-14), or Severe (>=15).

● The group of 523 platform users who completed two assessments of GAD-7 was evaluated;

297 users had baseline scores in the minimal-mild range and 226 were moderate or severe.

The severe group significantly improved their average GAD-7 score (P<0.001;

paired t-test).

A proportion of 68% from the severe users improved their score, and 42% of the severe users reported scores in minimal-mild range over the study period (P<0.001).

Moreover, 40% of the severe population experienced a clinically significant score reduction (reduction of >5) in GAD-7 over the study period.

● The minimal-mild group mostly maintained their levels and hence did not escalate to higher severity while using the care platform.

Additionally, out of 100 users who started at a moderate anxiety level, 84 (84%) improved or maintained their level (P<0.001), and out of 126 users started at a severe anxiety level, 69 (55%) reduced their level to moderate or minimal-mild (P<0.001).

In September 2022, a retrospective data analysis study was published in “International Association for the Study of Pain” large conference.

Pain level reduction mediated by perceived posture quality and training duration in patients using digital therapeutic biofeedback technology

The study sheds light on the nature of the linkage between posture biofeedback technology and pain reduction.

Based on the findings of our mediation model constructed on a lagged association between training duration, perceived posture quality, and pain levels, we suggest that posture quality is a potential mechanism for posture training-related analgesia.

A retrospective real-world study examined 981 users who used the Dario posture trainer.

Training duration, defined as the time the device is worn (hours), was recorded.

This study utilized the Dario posture trainer, Upright in Dario Health, a wearable postural biofeedback device.

Posture biofeedback training duration was significantly associated with pain levels (B=-0.0002, p<0.001).

Also, the training duration predicted the following week’s posture quality (B=0.0004, p<0.001) and in turn posture quality predicted the following week’s pain.

Finaly, posture quality mediated the effect of weekly training duration on the pain levels in two weeks.

In December 2022, the first manuscript was published in a peer-reviewed journal “ Frontiers in Physiology ” on retrospective data analysis on UpRight posture biofeedback platform.

The two-stage therapeutic effect of posture biofeedback training on back pain and the associated mechanism:

A retrospective cohort study

The study findings provided a better understanding of the therapeutic dynamic during digital biofeedback intervention targeting pain, modeling the associated two-stage process.

Moreover, the study sheds light on the biofeedback mechanism and may assist in developing a better therapeutic approach targeting perceived posture quality.

This retrospective real-world evidence study followed 981 users who used the UpRight posture biofeedback platform.

Piecewise mixed models were used for modeling the two-stage trajectory of pain levels, perceived posture quality, and weekly training duration following an 8-week biofeedback training.

Also, the mediation effect of perceived posture quality on the analgeic effect of training duration was tested using Monte Carlo simulations based on lagged effect mixed models.

The analysis revealed significant pain level reduction of 50% ( p <.0001) and posture quality improvement ( p <.0001) during the first 4 weeks of the training, maintaining similar pain levels and perceived posture quality during the next 4 weeks.

In addition, weekly training duration demonstrated an increase during the first 3 weeks ( p <.001) and decreased during the next 5 weeks ( p <.001).

Moreover, training duration predicted following-week perceived posture quality ( p <.001) and in turn perceived posture quality predicted following-week pain ( p <.001) ( p = 0.30).

Finally, perceived posture quality mediated the effect of weekly training duration on the pain levels in 2 weeks ( p <.0001).

In January 2023, a manuscript was published in a peer-reviewed journal “ MDPI-Applied sciences ” on retrospective data analysis glycemic management across Racial/Ethic groups:

Glycemic Management by a Digital Therapeutic Platform across Racial/Ethnic Groups:

A Retrospective Cohort Study

Our findings demonstrate improvement in blood glucose levels in high-risk racial/ethnic minority populations with T2DM, showing that in this group of users who are motivated to use a digital device there appears to be no difference in the outcomes between racial/ethnic groups.

The retrospective real-world analysis followed a group of 1,000 people with Type 2 diabetes who used the Dario digital therapeutic platform over 12 months.

Participants included in the study had a blood glucose average > 180 mg/dL (hyperglycemia, high-risk) in their first month.

The differences between/within the groups’ average blood glucose level (Avg.bg) and glycemic variability were evaluated.

Furthermore, three general linear models were constructed to predict the Avg.bg by the number of blood glucose measurements (Bgm) in Model 1 (with the moderator White persons ( " WP " )/people from racial and ethnic minority groups ( " REM " )) and by the frequency of measurements by months (F.m) within REM and WP in Model 2 and Model 3, respectively.

The Avg.bg was significantly reduced in each group over a year with no differences between REM/WP users.

Blood glucose measurements in Model 1 and frequency of measurements by months in Model 2 and Model 3 predicted the Avg.bg.

Findings indicate a positive association between digital engagement and glycemia, with no differences between REM and WP participants.

In February 2023, a manuscript was published in a peer-reviewed journal “ PAIN reports ” on an analytical framework of retrospective data for personalized pain management using piecewise mixed-effects model trees:

Personalizing digital pain management with adapted machine learning approach

This analytical framework offers an opportunity for investigating the personalized efficacy of digital therapeutics for pain management, taking into account users' characteristics and boosting interpretability and can benefit from including more users' characteristics.

We demonstrated the implementation of the model with posture biofeedback training data of 3610 users collected during 8 weeks.

The users reported their pain levels and posture quality.

We developed personalized models for nonlinear time-related fluctuations of pain levels, posture quality, and weekly training duration using age, gender, and body mass index as potential moderating factors.

Pain levels and posture quality demonstrated strong improvement during the first 3 weeks of the training, followed by a sustained pattern.

The age of the users moderated the time fluctuations in pain levels, whereas age and gender interactively moderated the trajectories in the posture quality.

Train duration increased during the first 3 weeks only for older users, whereas all the users decreased the training duration during the next 5 weeks.

In February 2023, we presented two additional clinical studies at the ATTD conference in Berlin, Germany:

Decrease in Hypoglycemia Events over Year in Older adults with Diabetes Monitoring with Digital Diabetes Management System

Older adults using a digital diabetes management platform have the potential to promote behavioral change and prevent hypoglycemia, demonstrating better glycemic outcome.

A retrospective data analysis was performed on the Dario database.

A cohort of users aged 67 or older with Type 1 or Type 2 diabetes and using Dario over a year was evaluated.

Average numbers of Hypoglycemia Level 1 (<70mg/dL) and Level 2 (<54 mg/dL) events as defined by the ADA were observed monthly and compared to baseline (first month).

In the cohort of 28 44 users, hypoglycemia level 1 events were reduced by 31% and 35% from baseline (0.54, 0.51 vs.

0.78) on average within 6 months and sustained over a year (p<0.05).

Hypoglycemia level 2 events were reduced by 53% (0.08, 0.08 vs.

0.17) on average within 6 months and sustained over a year (<0.05).

The ratio of hypoglycemia readings per total measurements significantly reduced as well.

Subgroup analyses (1353 patients) of Dario users aged 67

or older with Type 1 or Type 2 using Insulin revealed a substantial reduction of severe hypoglycemia Level 2 of 42% (0.11 vs.

0.19) (p<0.05) and significant reduction in hypoglycemia events ratio as well over a year.

Impact of Digital Coaching on Diabetes

Self-management and Glycemic Outcomes for People with Type 2 Diabetes

Self-monitoring blood glucose and digital engagement have a mediating role in the effect of digital coaching on blood glucose levels.

Coaching interactions have the potential to lead to behavioral change, which can positively impact the trajectory of a low-engaged user.

By constantly learning from the user's data, the digital therapeutic platform can continually improve and adapt to the user's individual needs, leading to better outcomes.

The study demonstrated that our platform is digital first where the human coaching intervention is provided to the right user at the right time and with the right intervention.

Retrospective data analysis was performed on a sample size of 712 users with type 2 diabetes with baseline average >180 mg/dL measured blood glucose over 12 months on the platform.

534 did not use a coaching service and 178 users interacted with a coach over a year.

Monthly Average blood glucose level significantly reduced in both groups w and w/o coach interaction over a year (18% vs.

Blood glucose measurements and digital engagement activities mediated the effect of coaching on average blood glucose levels.

For individuals who are less inclined to measure their blood glucose, coaching can help establish regular monitoring habits and to understand the importance of monitoring their levels.

In June 2023, we presented three clinical studies at the 83 th ADA conference:

Blood Glucose Reduction and Long-term Sustainability in High-risk Patients with Type 2 Diabetes Over Three Years Using a Digital Platform

The study showed that digital diabetes monitoring has the potential to enhance users’ awareness and affect and sustain glycemic control improvements over 3 years.

Moreover, it is highly expected that engagement to app features in a chronic condition management may help users with type 2 diabetes consistently taking care of their lifestyle behaviors to maintain better clinical outcomes.

A retrospective data analysis was performed on users with T2D in high-risk (baseline BG avg>169 mg/dL in month1;

equivalent to A1C 7.5) who activated between 2017-2020 and measured their BG using Dario platform over three consecutive years (at months 1,6,12,24 and 36).

The outcomes assessed were average blood glucose (BG avg) and high BG readings ratio (>180 mg/dL).

Digital engagement was assessed by additional parameters including measurement type (fasting/premeal/post meal/bedtime), carbohydrate intake, meal type and physical activity alongside glucose measurement.

A group of 1,239 users significantly reduced their BG avg consistently over three years by 15.6% (179±55 vs.

212±42) (p<0.05) and high readings ratio by 39% (p<0.05).

A subset of users who completed at least one engagement type following months 12, 24, and 36 (N=433) demonstrated significantly greater reductions versus the complementary group (N=806):

BG avg by 18.8% (172±51 vs.

212±45) and high readings ratio by 45% (p<0.05).

Digital Platform Users Managing Three Chronic Conditions Diabetes, Hypertension and Overweight Experience Better Outcomes than those Who Manage One Condition Following Six Months

Monitoring several conditions on an integrated platform may have the potential to offer a greater means for a person with diabetes to effectively manage glycemia, engage with the treatment and improve outcomes.

This study can illuminate the relative contribution of multi chronic conditions management driving behavioral change to successful diabetes outcomes.

A retrospective data analysis was performed on users who were active during 2019-2022 and measured blood glucose (BG) using Dario platform for at least six months.

The test group included users who measured blood pressure (BP) and weight within 6 months from their first BG measurement;

a matched control group of users who measured BG only in the first six months was generated.

BG levels were assessed by average BG (BG avg) and BGMS engagement was assessed by counting BG measurements per month.

High-risk users were defined as those with baseline BG avg>180mg/dL in Month 1.

A total number of 17,108 users were included in the study:

a test group of 2154 users measured BG, BP and Weight in the first six months on the platform and a control group of 14,954 users measured BG only in the first six months on the platform.

The test group (N=2,154) demonstrated significantly greater (1.7-fold) engagement evaluated by higher number of BG measurements, than the control group (N=14,954) in Month 1 and Month 6 (p<0.01).

A subgroup of the test group, 343 users at high-risk who measured 3 conditions BG, BP and weight was evaluated.

A matched control group of 1,579 high-risk users was generated.

The high-risk test group (N=343) demonstrated significantly greater reduction in BG avg versus the control subgroup (N=1579) measured BG only, after 6 months (17% vs.11%) (p<0.01).

Moreover, the ratio of population that reduced their BG avg to lower than 180 mg/dL after 6 months (equivalent to A1C 8.0;

HEDIS measure) was significantly higher in the test subgroup versus control subgroup in high-risk (by 30%;

Impact of a Digital Health Educational Feature on Engagement and Glycemic Outcomes

The present study demonstrates that by providing improved knowledge, increased motivation, and personalized learning digital health educational features can help users feel more empowered to manage their diabetes effectively.

A retrospective data evaluation study was performed on Dario TM members with type 2 (T2D) and prediabetes who experienced the educational feature.

Engagement (blood glucose measurements and logging carbs to Dario mobile app) and glycemic outcomes were assessed three months pre-post experiencing the feature.

Glycemic outcomes were assessed by average blood glucose (mg/dL) and glycemic variability (SD).

A group of 994 people with type 2 and prediabetes who were active in the mobile app and measured their blood glucose three months before using the new feature and in the following three months after, was evaluated.

The average number of blood glucose measurements increased by 34% (p<0.05) following the introduction of the new learning feature.

A subgroup of 303 users with type 2 and prediabetes that reported depression in the app as a co-existing condition increased carbs logging event by 39%.

In a subgroup of 234 high-risk users (baseline >180 mg/dL) the average blood glucose and glucose variability were significantly reduced by 13% and 11% on average, respectively (p<0.05).

In August 2023, we presented an additional clinical study on the benefits of engagement with a digital therapeutic for better clinical outcomes at the ADCES conference.

Users managing Diabetes with Large-scale Digital Therapeutics Platform Experience a Change in Blood Glucose and Engagement Over Two Years.

The present study demonstrates the benefits of engagement with a digital therapeutic platform for diabetes management in high-risk patients, demonstrating an improvement in glycemic outcomes and sustainment for a significant period.

A retrospective real-world data study was performed on the Dario database.

The current sample is based on active users since 2019 with at least two months measurements for two years.

Engagement was assessed by BG and weight measurements.

Clinical outcomes assessed were average BG and high readings (>180mg/dL) ratios.

Linear mixed effects models investigated changes in engagement and clinical outcomes.

A population of 119,482 platform users was included, Age:

High-risk subgroup included 31,562 users with first month (baseline) average BG>180 mg/dL.

Total users’ engagement increased significantly by 29% (14.3 to 18.5) over two years (p<0.001).

High readings ratio (>180mg/dL) in high-risk subgroup decreased significantly by 38% (38.8% vs.

63.1%) over two years (p<0.001).

The monthly average BG of the high-risk subgroup was reduced significantly by 16% (218.1mg/dL to 183.4mg/dL) over two years (p<0.001).

A negative interaction effect was found with monthly engagements and the monthly average BG, as users with increased engagements (+1 SD) demonstrated stronger reductions in monthly average BG.

In September 2023, a manuscript was published in a peer-reviewed journal “ Journal of Medical Internet research (JMIR) Diabetes” on the contribution of specific digital engagement tools to mental health conditions – Depression and Anxiety.

Specifying the Efficacy of Digital Therapeutic Tools for Depression and Anxiety:

Retrospective, 2-Cohort, Real-World Analysis

This study demonstrated general improvement followed by a period of stability of depression and anxiety symptoms associated with cognitive behavioral therapy–based digital intervention.

Interestingly, engagement with a coaching session but not a breathing exercise was associated with a reduction in depression symptoms.

Moreover, breathing exercise but not engagement with a coaching session was associated with a reduction of anxiety symptoms.

These findings emphasize the importance of using a personalized approach to behavioral health during digital health interventions.

Depression and general anxiety symptoms were evaluated in real-world data cohorts using the digital health platform for digital intervention and monitoring change.

This retrospective real-world analysis of users on a mobile platform–based treatment followed two cohorts of people:

(1) users who started with moderate levels of depression and completed at least 2 depression assessments (n=519) and (2) users who started with moderate levels of anxiety and completed at least 2 anxiety assessments (n=474).

Levels of depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) were tracked throughout the first 16 weeks.

A piecewise mixed-effects model was applied to model the trajectories of the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 mean scores in 2 segments (1-6 weeks and 7-16 weeks).

Finally, simple slope analysis was used for the interpretation of the interactions probing the moderators:

coaching sessions and breathing exercises in both depression and anxiety cohorts.

Analysis revealed a significant decrease in depression symptoms ( β =–.37, 95% CI –0.46 to 0.28;

P ≤.001) during the period of weeks 1-6 of app use, which was maintained during the period of 7-16 weeks.

Coach interaction significantly moderated the reduction in depression symptoms during the period of weeks 1-6 ( β =–.03, 95% CI –0.05 to –0.001;

A significant decrease in anxiety symptoms ( β =–.41, 95% CI –0.50 to –0.33;

P ≤.001) was revealed during the period of 1-6 weeks, which was maintained during the period of 7-16 weeks.

Breathing exercises significantly moderated the reduction in anxiety symptoms during the period of 1-6 weeks ( β =–.07, 95% CI –0.14 to –0.01;

In November 2023, we presented additional clinical study data at the virtual DTS meeting that investigated the association between monthly aggregated blood glucose measurements and walking activity (number of steps).

Non-linear Association between Blood Glucose Levels and Walking in an Integrated Digital Health Platform for Diabetes Management

This study sheds light on the importance of walking in diabetes management.

Our findings highlight the potential of digital health platforms in promoting physical activity using a diabetes tracking app to improve clinical outcomes.

By integrating the information that counts steps people with diabetes can access a single platform that helps them feel supported in their daily diabetes care and lifestyle management.

In this retrospective real-world study, a cohort of 989 platform users with Type 2 diabetes and pre-diabetes, who regularly tracked their blood glucose levels for 12 months using the Dario digital platform was evaluated.

The association between blood glucose levels and the number of steps was examined over time.

A piecewise linear mixed effects model was applied to test the trajectories over time of monthly average blood glucose and monthly average number of steps a day in two time periods defined by previous research 3 as well as to test non-linear association between them.

The sample included 437 (44%) women, 546 (55%) men and 6 (0.6%) others.

The average age was 62.5 (SD ±12.7) and the average BMI was 32.5 (SD ±6.9).

The baseline average BG was 142.5 mg/dL (SD ±37.7).

808 (82%) users have type 2 diabetes and 181 (18%) have pre-diabetes.

Analysis revealed that during the first 4 months there is a positive trend of monthly average steps ( B =.02, P <.001) while there is a negative trend of blood glucose levels ( B = -2.00, P <.001) in the same time frame.

Significant improvement in monthly average blood glucose was observed in users with at least 400 steps a day (B= -2.26, P <.001), while for those with less than 400 steps a day there was no significant change.

Certain clinical studies were published by Sanofi on our data in 2023.

The first poster was published at ISPOR May 2023.

Comparison of All-Cause Healthcare Resource Utilization Rates between Patients with Type 2 Diabetes Who Use a Digital Diabetes Solution Versus Non-Users:

A 12-Month Retrospective Cohort Study

In this retrospective cohort study, utilizing Dario Diabetes Solution (DDS) demonstrated a significantly greater reduction in all-cause HCRU and inpatient hospitalization rates during 12-month follow-up compared with non-users receiving usual care.

This retrospective cohort study (January 2017–April 2021) included adults (≥18 years) with T2DM receiving anti-diabetic medication(s) with ≥1 inpatient or ≥2 outpatient visits ≥30 days apart during baseline period.

Baseline was 12 months before index date (first DDS registration [users] or first medical encounter in the quarter with medical claims [non-users]);

follow-up was 12 months.

User and non-user cohorts were matched 1:3 using exact and propensity score matching.

Analysis included patients with access to care 12 months pre- and post-index date.

Primary endpoint was all-cause HCRU (inpatient hospitalizations + ER visits) rates during follow-up.

Data were analyzed using a generalized linear model with negative binomial distribution.

Of 9779 patients, DDS users (n=2445) and non-users (n=7334) were matched;

mean±SD age was 58.2±10.6 and 58.3±12.5 years, respectively.

At 12 months, mean (95% CI) all-cause HCRU rate (inpatient hospitalization + ER visits) was 0.475 (0.438–0.516) and 0.524 (0.500–0.549) events/year for users and non-users, respectively.

Users had 9.3% lower HCRU rate compared with non-users (incidence rate ratio [IRR], 0.907 [0.826–0.996];

Mean all-cause inpatient hospitalization rate was 0.166 (0.147–0.186) and 0.216 (0.203–0.230) events/year for users and non-users, respectively.

Users had 23.5% lower inpatient hospitalization incident rate versus non-users (IRR, 0.765 [0.671–0.873];

ER visit rates were similar in both cohorts (IRR, 1.01 [0.907–1.125];

Three studies were presented by Sanofi at the 83 th ADA conference:

Impact of Digital Diabetes Solution on Glycemic Control in Adults with Type 2 Diabetes Mellitus in the United States—A Retrospective Cohort Study

The study showed adults with uncontrolled T2DM using DDS had better outcomes at 6 months, with more significant HbA1c reductions than matched nonusers across various BL HbA1c levels, showing incremental improvements to usual care.

This retrospective cohort study included adults with T2DM with a baseline (BL) HbA1c ≥7% who used DDS (users) or received usual care (nonusers) between January 1, 2017, to October 31, 2021.

BL period was 1 year before index date (first DDS registration [users] or first claim date in the quarter [nonusers]);

follow-up period was 6 months.

DDS user and nonuser cohorts were matched 1:3 using exact and propensity score matching.

Primary endpoint was change in HbA1c from BL to 6 months, with subgroup analyses of patients (pts) with BL HbA1c >7.5%, >8%, >9%, and ≥1% drop from BL.

Difference-in-difference results are reported using least squares (LS) means from linear models.

The study included 568 DDS users and 1699 nonusers.

For all 2267 pts, mean ± SD age was 57.5±11.3 years and HbA1c was 9.14±1.83% at BL.

At 6 months, LS mean difference between groups was −0.23% (mean HbA1c change vs BL:

users, −1.02% [95% CI, −1.15, −0.89];

nonusers, −0.79% [−0.87, −0.71];

HbA1c drop ≥1% from BL to 6 months was achieved by 47% of users vs 37% nonusers (difference:

Subgroup analysis at all BL HbA1c showed users achieved more significant HbA1c reductions vs nonusers ( P <0.05).

For pts with BL HbA1c >9%, the healthcare effectiveness data and information set performance measure, mean difference between groups was -0.47% (users, -2.25% [-2.50, -1.99];

nonusers, -1.78% [-1.92, -1.63];

Use of Digital Diabetes Solution Is Associated with Improved Glycemic Control without Increased Risk of Severe Hypoglycemia in Adults with Type 2 Diabetes Mellitus in the United States—Retrospective Cohort Study

In this retrospective study, a larger proportion of adults with uncontrolled T2DM (BL HbA1c ≥8%) achieved HbA1c <8% after using DDS vs nonusers, with no increased risk of severe hypoglycemia (SH).

This retrospective cohort analysis included adults with T2DM who used DDS (users) and nonusers from 1JAN2017 to 31OCT2021.

BL period was 1 year before index date (users, first DDS registration;

nonusers, first claim

date in the quarter);

follow up was 6 months.

DDS users and nonusers were sequentially matched 1:3 using exact and propensity score matching.

Secondary endpoints included SH (event requiring medical intervention) rates for all patients (pts) and for pts with BL HbA1c ≥8% who achieved predefined target HbA1c <8%.

SH incidence in users vs nonusers was examined.

Overall cohort included 568 DDS users and 1699 nonusers:

mean age, 57.5±11.3 years;

mean BL HbA1c, 9.14±1.83%;

oral antidiabetic drugs, 51%;

BL SH was rare (users, 7/568;

nonusers, 12/1699).

There were 387 users and 1089 nonusers with BL HbA1c ≥8% (mean BL HbA1c, 10.0±1.7%).

In this subgroup, HbA1c <8% was achieved by 9% more DDS users (174/387 [45%]) vs nonusers (393/1089 [36%]) at 6 months;

At 6 months, overall SH rate was 38.8 (users) vs 10.6 (nonusers) events/1,000 pts per year (incidence rate ratio, 0.9;

No observed increase in SH risk was associated with DDS in this population.

SH was rare in pts who achieved HbA1c <8% (users, 1/174;

nonusers, 3/393).

Effect of a Digital Diabetes Solution on All-Cause Health Care Resource Utilization Charges for Patients with Type 2 Diabetes—A Retrospective Cohort Study

In this retrospective cohort study, pts with T2DM who utilized DDS incurred significantly lower all-cause HCRU and OV charges vs nonusers.

This retrospective cohort study (pt selection window:

1JAN2017 - 31APR2021) included adults (≥18 years) with T2DM receiving antidiabetic medication(s) with ≥1 inpatient or ≥2 outpatient visits ≥30 days apart during the baseline (BL) period.

BL was 1 year before index date (users, 1st DDS registration;

nonusers, 1st claim date in the quarter);

follow up was 1 year.

User and nonuser cohorts were matched 1:3 using exact and propensity score matching.

Study assessed HCRU rates and charges.

A 2-part gamma distribution model was used to determine 1) likelihood (odds ratio, OR) of users vs nonusers to incur charges, then 2) total charges per patient per year (PPPY) including all-cause HCRU and office visit (OV) charges.

Of 9779 pts, 2445 DDS users and 7334 nonusers were matched;

mean age, 58.2±10.6 and 58.3±12.5 years, respectively.

At 1 year, users were 9% less likely to incur all-cause HCRU charges vs nonusers (OR, 0.91;

All-cause HCRU charges were 26% lower for users vs nonusers ( P <0.0001;

$12552 [adjusted] PPPY savings).

Users were more likely to incur all-cause OV charges vs nonusers ( P =0.04).

However, users had 19% lower all-cause OV charges vs nonusers ( P <0.0001;

$1790 [adjusted] PPPY savings).

The percentages of pts who incurred T2DM related HCRU charges were low (users, 3.1%;

nonusers, 3.0%).

Three posters were published at AMCP-Nexus, in October 2023:

The impact of a digital health technology on healthcare quality measures and clinical outcomes in adults with type 2 diabetes mellitus

In this retrospective study, in adults with T2DM, a greater proportion of DDS users with BL A1c greater than or equal to 8% achieved A1c less than 8% and a smaller proportion with BL A1c greater than 9% remained greater than 9%, compared with a matched cohort of nonusers, without increasing the risk of severe hypoglycemia.

DDS offers improved quality outcomes based on HEDIS A1c criteria.

Cohorts of 568 DDS users and 1,699 nonusers were compared.

Inclusion criteria were as follows:

adults with a diagnosis of T2DM, receiving at least 1 diabetes medication, A1c greater than or equal to 7.0%, and not using a continuous glucose monitor between January 1, 2017, and October 31, 2021.

The primary endpoint was a change in A1c from baseline (BL) during a 180-day follow-up period, with subgroup analyses of people with BL A1c greater than 7.5%, greater than 8%, and greater than 9%.

Exploratory analyses were conducted to evaluate whether DDS use could facilitate a lowering of BL A1c from greater than or equal to 8% to less than 8% and from greater than 9% to less than 9% in adults with T2DM.

Secondary endpoints included severe hypoglycemia (event requiring medical intervention) rates for all included DDS users and nonusers and for those with BL A1c greater than or equal to 8% who achieved a predefined target A1c of less than 8%.

Overall, DDS user and nonuser cohorts were well matched , including by payer type (70% commercial and 18% Medicare for both groups).

Among 387 DDS users with BL A1c greater than or equal to 8%, 174 (45%) had A1c less than 8% during follow-up, compared with 393 (36%) of 1,089 nonusers (P=0.0021).

In a subgroup analysis of people with BL A1c greater than 9%, among 237 DDS users, 86 (36%) had follow-up A1c greater than 9%, compared with 347 (49%) of 713 nonusers (P=0.0009).

There was no increase in rates of severe hypoglycemia comparing groups (P>0.4).

Association between more frequent engagement with the Dario Diabetes Solution, a digital health technology, and a reduction in HbA1c in adults with type 2 diabetes mellitus

Higher DDS engagement was associated with a significantly greater reduction in A1c in adults with T2DM.

The highest engagement was in the first 2 months of follow-up and correlated with the greatest reductions in HbA1c.

Engagement decreased over time during follow-up.

Further research is needed to assess additional interventions that may sustain engagement over time.

This analysis included DDS users receiving at least 1 diabetes medication, with A1c ≥7.0%, and not using a continuous glucose monitor between January 1, 2017, and October 31, 2021.

Baseline (BL) was 1 year before the index date (first registration for DDS), with follow-up of 180 days from the index date.

Engagement activities were collected via the DDS app.

Engagement activity was measured in active days (ie, number of days when a user performed any engagement activity).

Ten DDS engagement activities were evaluated, including measuring BG, tagging (timing of BG measurement or meal type), food logging, and sharing logbook.

Associations between overall DDS engagement and change in A1c were analyzed over 180 days using a linear regression method, and associations were evaluated at 60- day intervals over those 180 days.

Individual components of engagement were also analyzed.

568 DDS users were included.

At BL, their mean age was 57.3 years (SD ±11.3) and mean A1c was 9.14±1.78%.

Median engagement activity was 65 active days of 180.

Each day with any DDS engagement activity was associated with a 0.01% change in A1c (P<0.0001).

Users in the most engaged quartile had 5× greater reduction in A1c than the least engaged quartile.

Individual engagement activities with significant associations with reduced A1c were BG measurement, tagging (meal type), and inputting insulin dose.

A retrospective cohort study comparing health care resource utilization, length of stay and 30-day readmissions in users and non-users of a digital diabetes health intervention for patients with type 2 diabetes mellitus.

In this real-world analysis, all-cause HCRU, inpatient, and 30-day readmission rates were significantly lower among DDS users vs nonusers (9%, 23%, and 36%, respectively), and LOS was significantly shorter (1.6 days).

In this retrospective cohort study, adults (aged >18 years) receiving therapy for type 2 diabetes who used DDS from January 1, 2017, to April 30, 2021, were identified;

index date was defined as the date of first DDS registration.

Anonymized DDS user data were linked to patient-level claims data within the Symphony Health Integrated Dataverse.

The DDS cohort was matched 1:3 using exact and propensity score matching to a nonuser cohort from the Symphony Health Integrated Dataverse with medical claims for type 2 diabetes mellitus during the study period.

For nonusers, the index date was the first medical claim date in the matched quarter.

All patients were required to have 12 months’ post-index follow-up and to have at least 2 outpatient claims (>30 days apart) or at least 1 inpatient claim within this period.

This analysis compared all-cause HCRU rates (inpatient + emergency department), LOS, and 30- day readmission rates in DDS users and nonusers.

Negative binomial generalized linear models adjusting for baseline rates were used to generate incidence rates (per personyear) and incidence rate ratios (IRRs) and corresponding 95% Cis for all-cause HCRU and 30-day readmission rates.

LOS was compared between groups using a two-sample t-test.

DDS users (n=2,445) and nonusers (n=7,334) were well matched (mean+SD age:

58.2+10.6 vs 58.3+12.5 years;

sex, 53.3% female for both).

At follow-up, the all-cause HCRU rate was 0.47 (95% CI= 0.44-0.52) in DDS users and 0.52 (95% CI= 0.50-0.55) in nonusers (IRR=0.91;

95% CI=0.83-1.00;

The mean all-cause inpatient event rate was 0.17 (95% CI= 0.15-0.19) in DDS users and 0.22 (95% CI= 0.20-0.23) in nonusers (IRR= 0.77;

95% CI= 0.67-0.87;

there was no significant difference in emergency department visits.

DDS users with an inpatient event (users, n=327;

nonusers, n=1,196) had a shorter LOS (7.2 vs 8.8 days;

P=0.017) and lower 30-day readmission rate (IRR= 0.64;

95% CI= 0.45-0.92;

P=0.014) vs nonusers.

Additional poster was presented at ISPOR EU, in November 2023.

The Impact of Patient Engagement with a Digital Diabetes Solution on All-Cause Healthcare Resource Utilization Rates and Charges

Overall engagement with DDS was associated with a reduction in all-cause HCRU and lower likelihood of incurring HCRU-related charges.

Patient-level claims data for adult DDS users (>18 years;

registered 01-Jan-2017 to 30-Apr-2021) receiving therapy for T2DM were retrieved from Symphony Health Integrated Dataverse.

All patients had >2 outpatient (>30 days apart) or >1 inpatient visit within 12 months prior to index (date of first DDS registration).

This analysis reports all-cause HCRU (inpatient + emergency room visits) and odds of incurring HCRU-related charges >$0 based on user engagement with any of 10 DDS activity metrics (‘components’ of activity metrics:

measuring BG, measuring blood pressure, measuring weight, tagging [BG timing and meal type], food logging, inputting insulin dose, recording physical activity, sharing logbooks, reading articles, coach interaction).

Overall engagement was defined as number of days any component was used within 12 months post-index.

All-cause HCRU rates and charges per 100 days of engagement were adjusted for baseline values with a negative binomial generalized linear model and logistic model, respectively;

incidence rate ratios (IRR) for HCRU and odds ratios (OR) for charges >$0 were derived.

We identified 2445 DDS users (mean+SD age, 58.2+10.6 years;

53.3% female).

Overall engagement (use of any DDS component) was associated with a 10% reduction in all-cause HCRU (IRR:

Overall DDS engagement was associated with 15% decreased odds of incurring all-cause HCRU-related charges >$0 (OR:

Another poster was presented at Diabetes Technology Society at Nov 2023, the abstract will be published in JDST early 2024.

The title is:

“Impact of a Digital Diabetes Solution on Medication Adherence in Adults in the United States with Type 2 Diabetes Mellitus”.

In March 2024, we presented two clinical studies at the ATTD conference in Florence, Italy:

Impact of a digital health intervention on awareness of vaccination against influenza among adults with diabetes

leveraging digital health technology to deliver knowledge and information can enhance influenza vaccination rates in diabetes population to reduce public health.

A real-world implementation study of a 6-month digital diabetes intervention was performed in U.S Dario users with diabetes.

A group of 64,952 users were randomly sorted to:

real-world group (RW) received messages designed in the digital platform;

A RCT group received messages as designed in previous published RCT;

Control group (C) received no intervention.

Difference in self-reported vaccination rates and flu risk awareness levels were tested.

A total of 8431 users (13% response rate) with diabetes typ1 or type 2 reported vaccination status.

No compensation was offered during digital intervention.

After a 6-month intervention, a numerical increase was observed in the real-world group (N=3068) versus the RCT (N=3505) and the Control group (N=1858) (71.9% vs.

71% and 70.5%, respectively) (p=0.521).

Awareness to the risk in getting Flu in diabetes and the impact of the content materials were significantly higher (p<0.005) in the real-world group vs RCT (1.2-fold) and Control (1.35-fold).

Impact of digital therapeutic platform on blood glucose and weight levels in prediabetes population

This study demonstrates the potential of digital platforms to improve self-management and clinical outcomes among users with prediabetes, thus assisting in lowering the risk of developing type 2 diabetes.

A retrospective data analysis was performed on the prediabetes population using the platform in 2020-2023, with at least 2-months measuring BG or weight.

Monthly Avg.BG, weight and digital activities were analyzed versus baseline (month 1).

A linear mixed model tree was applied testing potential moderators.

A group of 6853 users with prediabetes who managed their BG on the platform was included (Age 55.4±13;

53% females).

In the subgroup with baseline ≥154 mg/dL (A1c 7.0) (N=819) a significant reduction of 15% in AvgBG was observed after 6 months and maintained along the year (198.9 to 168.2 mg/dL, p<0.001).

In a subgroup with baseline ≥140 mg/dL (A1c 6.5) (N=1282) 66% have improved AvgBG and 40% reduced AvgBG <140mg/dL (p<0.001).

A significant reduction of 6.3% in weight was observed in users with baseline BMI≥30 (N=1186, p<0.001).

Meal tagging activity moderated the trajectory of weight improvement, monthly average >5 meal taggings had a statistically significant and stronger reduction in the average weight (-0.11, p<0.001) compared to ≤5 monthly average meal tagging (-0.08, p<0.001).

In February 2024 we published in a peer-reviewed journal “Journal of Medical Internet research (JMIR)”, the article:

The Impact of Digital Self-Monitoring of Weight on Improving Diabetes Clinical Outcomes:

Quasi-Randomized Study

This study highlights the substantial benefits of self-monitoring of weight in managing BG levels in patients with diabetes, facilitated by a digital health platform, and advocates for the integration of digital self-monitoring tools in chronic disease management.

We also provide initial evidence of testing the underlying mechanisms associated with BG management, underscoring the potential role of patient empowerment.

In this retrospective, real-world quasi-randomized study, 50% of the individuals who regularly used the weight monitoring (“WM”) feature were propensity score matched with 50% of the users who did not use the weight monitoring feature based on demographic and clinical characteristics.

All the patients were diagnosed with T2D and tracked their BG levels.

We analyzed monthly aggregated data 6 months before and after starting their weight monitoring.

A piecewise mixed model was used for analyzing the time trajectories of BG and weight as well as exploring the disaggregation effect of between- and within-patient lagged effects of weight on BG.

The WM group exhibited a significant reduction in BG levels post intervention (P<.001), whereas the non-monitoring group showed no significant changes (P=.59), and both groups showed no differences in BG pattern before the intervention (P=.59).

Furthermore, the WM group achieved a meaningful decrease in BMI (P<.001).

Finally, both within-patient (P<.001) and between-patient (P=.008) weight variability was positively associated with BG levels.

However, 1-month lagged back BMI was not associated with BG levels (P=.36).

Three studies were presented at the 84th ADA conference in June 2024:

Digital platform users taking GLP-1 and managing Diabetes adapt lifestyle behavior change over twelve months

The study showed how lifestyle monitoring components in a metabolic digital disease management solution have the potential to drive behavior change and enhance clinical care among users taking GLP-1 medications.

These lifestyle changes may be important in driving outcomes in users taking GLP-1 medications.

This study followed behavior change in users utilizing a new “medication cabinet” feature for medication logging and were identified as existing GLP-1 users, versus non-GLP-1 users.

The purpose of the study was to investigate monthly activities over twelve months of using a digital platform in GLP-1 users versus non-GLP-1 Metformin users.

A retrospective data analysis was performed on early users of “medication cabinet” with T2D and prediabetes who measured their blood glucose (BG) at months 1,3,6,9,12.

The GLP-1 group included users who reported taking GLP-1 and non-GLP-1 group reported taking metformin.

A piecewise mixed effects model was applied to follow monthly average BG and lifestyle digital activities (logging meal/reference, carbohydrate intake and calories burned).

A cohort of 107 users was evaluated:

GLP-1 (N=35) and non GLP-1 users (N=72).

The groups were statistically equivalent in baseline average BG (150 vs.

152 mg/dL) and monthly average BG measurements (31.3 vs 30.5).

GLP-1 users showed significant reduction in BG at months 1-5 (p=0.02) maintained throughout the year.

GLP-1 and non-GLP-1 users both demonstrated a statistically significant increase in lifestyle activities during their first three months (p<0.001, p=0.02 respectively) maintained for a year.

Moreover, mixed-effects model revealed a statistically significant increase in monthly average weight measurements over the year among GLP-1 users (p<0.001).

Deep sleep interaction with blood glucose levels in people using an integrated digital health platform for diabetes management

A digital health platform that aims to help users adjust deep sleep and manage blood glucose levels can be a powerful tool in promoting overall health and well-being.

Sleep quality assessment connected with blood glucose monitoring on one single platform may provide actionable insights and help users understand the impact of sleep on their metabolic health.

A retrospective data analysis included people with T2D and prediabetes who used iPhone and integrated data into Dario digital health platform during Dec 2022-Dec 2023.

Weekly aggregations of average BG and time of deep sleep were calculated.

A mixed model analysis was used to determine whether the weekly avg BG can be predicted by weekly avg duration of deep sleep over time.

A cohort of 417 users with type 2 and prediabetes was evaluated (Age 60.4±12.3;

female 50.3%).

A significant difference between weekly avg BG levels in different durations of weekly avg deep sleep was demonstrated by the model (B=-.00, CI 95% -0.00- -0.00, p=.029).

Moreover, simple slope analysis showed that users with increased weekly avg deep sleep duration have significantly stronger reductions in avg BG (B=-.26, CI 95% -0.50- -0.03, p=.03) compared to users with low weekly avg deep sleep duration (B=-.13, CI 95% -0.37- 0.12, p=.31).

Sustained reduction in blood glucose levels reflecting diabetes remission in people with type 2 diabetes using a digital health platform

This study exhibits the potential role of digital health technology to change individuals' behaviors during management of T2D and support patients to achieve remission.

A retrospective data analysis was performed on users with T2D who have reported not using insulin and were active on Dario platform >6 months during 2018-2024, measured their BG in the first month and >3 measurements in the last month.

Monthly Avg.BG and percentage of high readings (>180 mg/dL) versus baseline (first month) were evaluated Paired sample t-test was used for testing differences in AvgBG.

A linear mixed-effects model was applied to evaluate the changes in AvgBG and high-readings percentage over time.

Finally, a simple slope analysis was used for the interpretation of the interaction of AvgBG and high-readings percentage with lifestyle activities.

A group of 7240 users was evaluated (Age 53.8 (SD ±24.6);

41% females).

A ratio of 44% (3169/7240) reduced their last monthly AvgBG to <140 mg/dL (equivalent to estimated A1c of 6.5).

A sustained AvgBG of <140 mg/dL for at least three consecutive months was observed in 70% (2223/3169) of the users reflecting diabetes remission.

The AvgBG was reduced by 15% vs.

baseline (P<.001) in this group.

In addition, users at high-risk with a baseline AvgBG ≥183 mg/dL demonstrated significant reductions in AvgBG and high-readings percentage in their last month moderated by the number of monthly lifestyle activities (logging carbs, meals and physical activities) as revealed by the model (B=-.00, P=.02 and B=-.00, P=.002 respectively).

In August 2024 we published in a peer-reviewed journal “Frontiers in Endocrinology” the article:

Walking away from depression:

the mediating role of walking activity in depression impacting blood glucose levels of people with diabetes or prediabetes

This study shows how regular walking may reduce the negative impact of depression on BG levels in people with T2D.

Our findings advocate for the integration of walking activity into treatment protocols as a cost-effective, accessible intervention strategy to improve glycemic management and depressive symptoms in this population.

A cohort of 989 users with T2D and prediabetes, who regularly tracked their steps levels and BG levels for 12 months using the Dario digital health platform was evaluated.

The mediating role of the monthly average number of steps on the relationship between the self-reported depression status and lagged monthly average BG was assessed.

Additionally, the association between monthly walking activity and monthly average BG was tested using a piecewise linear mixed effects model

Users with self-reported depression demonstrated increased BG levels compared to users without depression (B=8.00, P=.01).

The association between depression and monthly average number of steps was significant (B=-.27, P<.005) and monthly average number of steps significantly predicted the following months’ average BG (B=-.81, P=.001), adjusting for depression.

The monthly average number of steps significantly mediated the effect of self-reported depression on the following month’s average BG (M=.22, P<.005).

Further sensitivity analysis demonstrated model robustness over various periods.

Finally, non-linear dynamics of walking activity over time was validated using unseen data showing a decrease in monthly average BG for users with over an average of 400 steps per day (B=-1.87, P<.01).

In March 2024 two studies were published in the behavioral health field.

An RCT study was published on Happify for Teens (Twill) we published in a peer-reviewed journal “Journal of Medical Internet research (JMIR)”, the article:

Effects of a Digital Mental Health Intervention on Perceived Stress and Rumination in Adolescents Aged 13 to 17 Years:

Randomized Controlled Trial.

Happify for Teens was effective at reducing perceived stress, rumination, and loneliness among adolescents over 12 weeks when compared to a waitlist control group.

Our data reveal the potential benefits of DMHIs for adolescents, which may present a more scalable, destigmatized, and cost-effective alternative to school-based programs.

This was a 12-week, 2-arm decentralized randomized controlled trial of adolescents aged 13 to 17 years who presented with elevated levels of perceived stress and brooding.

Participants were randomly assigned to engage with a self-guided DMHI (Happify for Teens) or to a waitlist control.

Participants assigned to the intervention group were given access to the program for 12 weeks.

Happify for Teens consists of various evidence-based activities drawn from therapeutic modalities such as cognitive behavioral therapy, positive psychology, and mindfulness, which are then organized into several programs targeting specific areas of concern (eg, Stress Buster 101).

Participants in the waitlist control received access to this product for 12 weeks upon completing the study.

Participants in both groups completed measures of perceived stress, brooding, optimism, sleep disturbance, and loneliness at baseline, 4 weeks, 8 weeks, and 12 weeks.

Changes in outcomes between the intervention and waitlist control groups were assessed using repeated-measures multilevel models.

Of the 303 participants included in data analyses, 132 were assigned to the intervention and 171 to the waitlist.

There were significantly greater improvements in the intervention condition for perceived stress (intervention:

95% CI –1.82 to –1.19;

P<.001 and control:

95% CI –0.44 to 0.26;

P=.61), brooding (intervention:

95% CI –1.00 to –0.68;

P<.001 and control:

95% CI –0.47 to –0.12;

P=.001), and loneliness (intervention:

95% CI –1.2 to –0.73;

P<.001 and control:

–0.64 to –0.12;

P=.005) over the 12-week study period.

Changes in optimism and sleep disturbance were not significantly different across groups (Ps≥.096).

A retrospective data analysis study published in a peer-reviewed journal “JMIR Formative Research” in the article:

Association of Digital Engagement with Relaxation Tools and Stress Level Reduction:

Retrospective Cohort Study

This study sheds light on the association between stress level reduction and specific components of engagement in a digital health app, breathing exercises, and cognitive behavioral therapy–based video sessions.

Our findings provide a basis for further investigation of current and moderating factors that contribute to the personalization of digital intervention.

In addition, results may aid in developing a more comprehensive understanding of how digital intervention tools work for mental health and for whom they are most effective.

Stress levels were evaluated in a real-world data cohort using a behavioral health app for digital intervention and monitoring change.

This retrospective real-world analysis of users on a mobile platform–based treatment followed users (N=490) who started with moderate and above levels of stress and completed at least 2 stress assessments.

The levels of stress were tracked throughout the first 10 weeks.

A piecewise mixed effects model was applied to model the trajectories of weekly stress mean scores in 2-time segments (1-6 weeks and 6-10 weeks).

Next, a simple slope analysis was used for

interpreting interactions probing the moderators:

breathing exercises and video sessions.

Piecewise mixed-effects models were also used to model the trajectories of specific perceived stress item rates in the stress questionnaire in the 2 segments (1-6 weeks and 6-10 weeks) and whether they are moderated by the relaxation engagements.

Simple slope analysis was also used here for the interpretation of the interactions.

Analysis revealed a significant decrease in stress symptoms (β=–.25;

95% CI –0.32 to –0.17;

P<.001) during the period of 1-6 weeks of app use that was maintained during the period of 6-10 weeks.

Breathing exercises significantly moderated the reduction in stress symptoms during the period of 1-6 weeks (β=–.07;

95% CI –0.13 to –0.01;

P=.03), while engagement in digital video sessions did not moderate stress scores.

Engagement in digital video sessions, as well as breathing exercises, significantly moderated the reduction in perceived sense of burden and lack of productivity during weeks 1-6 and remained stable during weeks 6-10 on both items.

Evidence Generation Strategy

Strategic Investment in Clinical Research

We have made sustained, strategic investments in clinical research and real-world evidence generation to support the validation, differentiation, and long-term value of its digital health platforms.

Over the past eight years, the company has invested approximately $8 million in clinical studies and evidence development.

Scope and Breadth of the Evidence Base

We have built one of the most extensive evidence bases in digital health, spanning diabetes, cardiometabolic disease, weight management, musculoskeletal health , and behavioral health.

The research portfolio includes over 100 publications, abstracts, and conference presentations across leading medical, scientific, and health-economics venues, such as American Diabetes Association (“ADA”), the Journal of Medical Internet Research (“JMIR”), Frontiers, Advanced Technologies And Treatments For Diabetes, and the International Society for Pharmacoeconomics and Outcomes Research (“ISPOR”).

Studies encompass retrospective cohort analyses, pragmatic and quasi-experimental designs, randomized controlled trials, machine-learning–driven analyses , and claims-based economic evaluations conducted across employer, health plan, and life-sciences populations.

Real-World Evidence and Clinical Outcomes

A central pillar of the research strategy is real-world evidence generation, leveraging large-scale longitudinal data from the Company’s platforms to evaluate clinical effectiveness, engagement, and healthcare utilization in routine care settings.

Across multiple real-world studies, use of the Dario digital diabetes and cardiometabolic solutions has been associated with clinically meaningful and sustained improvements in glycemic control, reductions in hypoglycemia events ( including among older adults ), improvements in blood pressure and weight, and favorable outcomes across diverse demographic and high-risk subpopulations .

Claims-based analyses have also demonstrated associations with reductions in healthcare utilization and total cost of care in certain populations .

Multi-Condition Management and Specialized Programs

The evidence base extends beyond diabetes to include studies evaluating GLP-1 therapy support and weight management, emphasizing the role of behavioral engagement and personalization in adherence and durability of outcomes.

In musculoskeletal health, peer -reviewed and conference studies demonstrate associations between posture and biofeedback technologies and reductions in pain, ergonomic risk, and functional impairment.

In behavioral and mental health , randomized and real-world studies show improvements in stress, anxiety, depressive symptoms , wellbeing, and productivity , as well as favorable economic impact from payer and employer perspectives .

Advanced Analytics , Personalization, and Data-Driven Insights

Dario integrates advanced analytics and machine learning into its research and product development to personalize interventions, predict outcomes, and optimize care pathways at scale.

Consumer and D2C data analyses further support employer and health plan value propositions and inform engagement and product strategy .

Independent Validation and Scientific Leadership

To enhance credibility and transparency, Dario periodically engages independent third-party evaluators and external partners to assess clinical and economic outcomes.

Findings are disseminated through peer-reviewed journals and scientific conferences, reinforcing the Company’s scientific leadership and contribution to the digital health evidence base.

Notable Findings

Consistent with the Company’s evidence-generation strategy described above, Dario’s clinical and real-world evidence portfolio includes peer-reviewed publications and scientific presentations spanning the cardiometabolic, behavioral health, and musculoskeletal conditions addressed by our platform.

The studies below represent a sample from our broader research portfolio and illustrate findings across clinical outcomes, healthcare utilization and economic impact, engagement and predictive analytics, and outcomes in behavioral health and musculoskeletal programs.

Results reported in these studies represent associations observed in retrospective, observational, or pragmatic study designs, and outcomes vary by population, engagement level, and context.

Clinical Outcomes in Cardiometabolic Health

Impact of Digital Diabetes Solution on Glycemic Control in Adults with Type 2 Diabetes Mellitus in the United States—Retrospective Cohort Study (Sanofi;

A retrospective cohort study comparing Dario Diabetes Solution (“DDS”) users with matched non-users receiving usual care demonstrated greater HbA1c improvement among DDS users at six months, including among individuals with higher baseline HbA1c levels.

DDS users were more likely to achieve a ≥1% HbA1c reduction and showed greater improvements among individuals with baseline HbA1c greater than 9%.

Use of Digital Diabetes Solution and Risk of Severe Hypoglycemia in Adults with Type 2 Diabetes Mellitus—Retrospective Cohort Study (Sanofi;

A related retrospective analysis in adults with uncontrolled type 2 diabetes reported that a greater proportion of DDS users achieved HbA1c levels below 8% compared with matched non-users, with no increased risk of severe hypoglycemia reported.

Digital Intervention Messages for High Blood Pressure (JMIR Cardio 2025).

A real-world retrospective study of 408 users evaluated targeted digital intervention messages for high blood pressure events.

Users receiving the intervention experienced greater reductions in monthly average systolic blood pressure compared with a control group, with higher levels of lifestyle activity associated with greater improvements.

GLP-1 Adherence and Post-Discontinuation Outcomes (ADA 2025).

A study presented at the ADA evaluated the role of a digital health platform in supporting GLP-1 medication adherence and outcomes following treatment discontinuation.

The Study showed that lifestyle-related digital engagement activities, including meal and physical activity logging, moderated reductions in monthly average blood glucose, and blood glucose and weight remained stable during the six months following treatment discontinuation.

Digital Health Intervention to Improve Influenza Vaccination Awareness Among Adults with Diabetes—Pragmatic Randomized Study (JMIR 2025).

This pragmatic randomized study evaluated a digital intervention designed to improve awareness of influenza vaccination among adults with diabetes and demonstrated the potential of targeted digital messaging to support preventive care behaviors in real-world populations.

Healthcare Utilization and Economic Outcomes

Comparison of Healthcare Resource Utilization Between Digital Diabetes Solution Users and Non-Users—12-Month Retrospective Cohort Study (Sanofi;

This claims-based analysis reported lower inpatient hospitalization rates and lower overall healthcare resource utilization among DDS users over a 12-month period, while emergency department visit rates were reported as similar between groups.

Observational Medical Cost Analysis in Employer Populations (ISPOR 2025).

An observational analysis presented at the ISPOR conference evaluated medical cost outcomes among an employer population participating in the platform.

The study reported reductions in total medical and inpatient costs on a per-member-per-month basis, with the largest reductions observed among individuals with multiple cardiometabolic conditions.

Engagement, Personalization, and Predictive Analytics

Predictive Modeling Using Clinical Biomarkers (ADA 2025).

This study described a machine learning–based predictive model integrating digital behavioral data with clinical biomarkers to support personalized diabetes management.

Predictive variables included blood glucose patterns, measurement frequency, step count, and food and activity tracking, demonstrating the potential of combining behavioral and clinical data to forecast future glycemic outcomes.

Machine Learning Decision Trees for Glycemic Response Stratification (ADA 2025).

Machine learning decision trees were used to identify glycemic response patterns among individuals with type 2 diabetes.

The model stratified users by insulin use and years since diagnosis, with stronger early improvements observed among individuals with higher engagement in glucose monitoring.

Machine Learning and Demographic Factors in Blood Glucose Management (ADA 2025).

This analysis examined demographic influences on blood glucose outcomes within the digital platform.

Age was identified as a key factor influencing glucose variability, while gender, BMI, and ethnicity did not significantly moderate outcomes.

Members over age 60 demonstrated increased engagement in lifestyle activity tracking during early program participation.

Additional Outcomes in Behavioral Health and Musculoskeletal Care

Digital Therapeutics for Depression and Anxiety—Real-World Outcomes (JMIR 2023).

A retrospective real-world analysis reported significant reductions in depression and anxiety symptoms during early engagement with a digital therapeutic program, with improvements maintained over time.

Coaching interactions and breathing exercises were associated with enhanced outcomes in specific symptom domains.

Posture Biofeedback Training for Back Pain—Retrospective Cohort Study (Frontiers in Physiology 2022).

A real-world evidence study of posture biofeedback training demonstrated substantial reductions in back pain over an eight-week period, with a majority of participants achieving clinically meaningful improvement.

Government Regulation

The principal markets that we have initially targeted for Dario are the United States, Canada, the European Union, Australia, and New Zealand.

The following is an overview of the regulatory regimes in these jurisdictions.

The following is an overview of the regulatory authorities in the jurisdictions we operate in.

United States Regulation Generally

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A predicate device is a legally marketed device that is not subject to PMA, meaning, (i) a device that was legally marketed prior to May 28, 1976, or pre amendments device, and for which a PMA is not required, (ii) a device that has been reclassified from Class III to Class II or I, or (iii) a device that was found substantially equivalent through the 510(k) process.

The FDA typically issues a decision within 90 days of receipt of a 510(k)

submission but may stop the review clock for up to 180 days to request that the applicant respond to the agency’s requests for additional information about the proposed device.

The FDA typically issues a decision within 90 days of receipt of a 510(k) submission but may stop the review clock for up to 180 days to request that the applicant respond to the agency’s requests for additional information about the proposed device.

If the FDA agrees that the device is substantially equivalent to the predicate device identified by the applicant in a premarket notification submission, the agency will grant 510(k) clearance for the new device, permitting the applicant to commercialize the device.

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If FDA grants the De Novo request, the device may be legally marketed in the United States.

However, the FDA may reject the classification request if the agency identifies a suitable legally marketed predicate device that provides a reasonable basis for review of substantial equivalence or determines that the device is not low to moderate risk or that general controls would be inadequate to control the risks and adequate special controls cannot be developed.

and adequate special controls cannot be developed.

De Novo classification requests are subject to user fees, unless a specific exemption applies.

Premarket Approval (PMA) .

Premarket Approval .

The PMA process is more demanding than the 510(k) and De Novo classification processes.

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If the FDA’s evaluation of a PMA application or manufacturing facility is not favorable, the FDA will deny approval of the PMA or issue a “not approvable letter.” The FDA may also determine that additional studies are necessary, in which case the PMA approval may be delayed for several months or years while such additional studies are conducted, and data is submitted in an amendment to the PMA.

The PMA process can be expensive, uncertain and lengthy, and each PMA submission is subject to a substantial user fee

unless a specific exemption applies.

The PMA process can be expensive, uncertain and lengthy, and each PMA submission is subject to a substantial user fee unless a specific exemption applies.

PMA approval may also be granted with post-approval requirements such as the need for additional patient follow-up or requirements to conduct additional clinical trials.

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In general, software that is intended for a medical purpose, whether it is included with a hardware device or is standalone software, is considered a medical device and subject to the same regulatory pathways described above, as long as it meets the definition of a “device” in Section 201(h) of the FDCA.

However, the 21st Century Cures Act, which became law in December 2016, expressly excluded from the FDCA’s device definition some software functions, such as software to support healthcare facility administration, general wellness software, electronic health records and certain clinical decision support software.

However, the 21st Century Cures Act, which became law in December 2016, expressly excluded from the FDCA’s device definition some software functions, such as

software to support healthcare facility administration, general wellness software, electronic health records and certain clinical decision support software.

In September 2019, the FDA published a revised guidance, General Wellness:

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The FDA issued a Final Rule on February 2, 2024, describing amendments to harmonize the QSR with the 2016 edition of the International Organization for Standardization publication Medical Devices:

Quality management systems—Requirements for regulatory purposes (ISO 13485:2016), which will become effective on February 2, 2026.

Quality management systems—Requirements for regulatory purposes (ISO 13485:2016), which became effective on February 2, 2026.

The harmonization process is not expected to have a significant impact on the quality system compliance operations of device manufacturers because most requirements described in the QSR correspond to requirements set forth in ISO 13485:2016.

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The EU presently requires that all medical products be certified to meet the EU’s safety and performance requirements for such products and bear a CE mark, an international symbol of adherence to quality assurance standards and demonstrated clinical effectiveness.

Prior to May 26, 2021, all medical devices placed on the EU market had to meet the relevant essential requirements laid down in Council Directive 93/42/EEC, or the Medical Device Directive (MDD), and if applicable, the Council Directive 90/385/EEC, or the Active Implantable Medical Device Directive (AIMD), or for in vitro diagnostic devices, Council Directive 98/79/EC, or the In Vitro Diagnostic Directive (IVDD).

Active Implantable Medical Devices (AIMD) are defined as medical devices that rely on a source of electrical energy or any source of power other than that generated by the body, which are totally or partially introduced, either surgically or medically, into the human body and intended to remain after the procedure.

Prior to May 26, 2021, all medical devices placed on the EU market had to meet the relevant essential requirements laid down in Council Directive 93/42/EEC, or the Medical Device Directive (“MDD”), and if applicable, the Council Directive 90/385/EEC, or the Active Implantable Medical Device Directive (“AIMDD”), or for in vitro diagnostic devices, Council Directive 98/79/EC, or the In Vitro Diagnostic Directive (“IVDD”).

Active Implantable Medical Device (“AIMD”) are defined as medical devices that rely on a source of electrical energy or any source of power other than that generated by the body, which are totally or partially introduced, either surgically or medically, into the human body and intended to remain after the procedure.

On May 26, 2021, the Medical Devices Regulation, EU 2017/745, (“MDR”) became effective, repealing and replacing the MDD and the AIMDD.

The MDR is directly applicable in all EU member states.

The MDR changed several aspects of the regulatory framework for medical device marketing in Europe in order to increase regulatory oversight of all medical devices marketed in the EU (which, in turn, increased the costs, time and requirements to place innovative or high-risk medical devices on the European market).

The MDR changed several

aspects of the regulatory framework for medical device marketing in Europe in order to increase regulatory oversight of all medical devices marketed in the EU (which, in turn, increased the costs, time and requirements to place innovative or high-risk medical devices on the European market).

The MDR among other things (i) strengthens the rules on placing devices on the market and reinforces post-market surveillance;

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A Notified Body typically audits and examines a product’s technical dossiers and the manufacturer’s quality management system (which must, in particular, comply with ISO 13485).

If satisfied that the AIMD or other medical device conforms to the relevant GSPRs, the Notified Body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration

of conformity.

If satisfied that the AIMD or other medical device conforms to the relevant GSPRs, the Notified Body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity.

The manufacturer may then apply the CE-Mark to the device, allowing the device to be legally marketed throughout the EU.

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Under the IVDR and subsequent amendments, IVDs already certified by a Notified Body under the IVDD may remain on the market until May 26, 2025, and IVDs certified without the involvement of a Notified Body may be placed on, or remain in, the market for up to three additional years (until May 26, 2028) depending on the classification of the IVD.

The manufacturers of such devices remaining on the market must comply with specific requirements in the IVDR, but ultimately, such products, as with all new IVDs, will have to undergo the IVDR’s conformity assessment procedures.

The manufacturers of such devices remaining on the market must comply with specific requirements in the IVDR, but ultimately, such products, as with all new IVDs, will have to undergo the IVDR’s

conformity assessment procedures.

In addition, the IVDR imposes additional requirements relating to post-market surveillance and submission of post-market performance follow-up reports.

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Clinical trials are almost always required to support PMA applications and are sometimes required to support 510(k) and De Novo classification submissions.

All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s good clinical practice (GCP), regulations, including the investigational device exemption (IDE) regulations that govern investigational device labeling, prohibit promotion of investigational

devices, and specify recordkeeping, reporting and monitoring responsibilities of trial sponsors and investigators.

All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s good clinical practice (“GCP”), regulations, including the investigational device exemption (“IDE”) regulations that govern investigational device labeling, prohibit promotion of investigational devices, and specify recordkeeping, reporting and monitoring responsibilities of trial sponsors and investigators.

If the device presents a “significant risk,” as defined by the FDA, the agency requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical studies.

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If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the trial, the FDA may permit a clinical trial to proceed under a conditional approval or the sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

In addition, the trial must be approved by, and conducted under the oversight of, an institutional review board, or IRB, for each clinical site.

In addition, the trial must be approved by, and conducted under the oversight of, an institutional review board (“IRB”), for each clinical site.

If the device presents a non-significant risk to the patient according to criteria established by FDA as part of the IDE regulations, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate authorization from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.

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Information about certain clinical studies, including details of the protocol and eventually trial results, also must be submitted within specific timeframes to the National Institutes of Health (“NIH”), for public dissemination on the ClinicalTrials.gov data registry.

Information related to the product, patient population, phase of investigation, trial sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial.

Information related to the product, patient population, phase of

investigation, trial sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial.

Sponsors are also obligated to disclose the results of their clinical studies after completion.

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Department of Health and Human Services’ Final Rule and NIH’s corresponding policy on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and the government has brought enforcement actions against non-compliant clinical trial sponsors.

Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and more frequently if unanticipated serious adverse events, or SAEs, occur.

Progress reports detailing the results of the clinical studies must be submitted at least annually to the FDA and more frequently if unanticipated serious adverse events, occur.

The FDA or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

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the interim results of a study may not be satisfactory leading the sponsor or others to terminate the study, there may be an insufficient number of patients who qualify for the study or who agree to participate in the study or the investigator at the site may have priorities other than the study.

Also, there can be no assurance that the clinical study will provide sufficient evidence to assure

regulatory authorities that the product is safe, effective and performs as intended as a prerequisite for granting market clearance.

See “Clinical Trials” above for clinical trials performed to date.

Also, there can be no assurance that the clinical study will provide sufficient evidence to assure regulatory authorities that the product is safe, effective and performs as intended as a prerequisite for granting market clearance.

Post-Clearance Matters

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A device user facility must report any device-related death to both the FDA and the device manufacturer, or any device-related serious injury to the manufacturer (or, if the manufacturer is unknown, to the FDA) within 10 days of the event.

Device user facilities are not required to report device malfunctions that would likely cause or contribute to death or serious injury if the malfunction

were to recur but may voluntarily report such malfunctions through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

Device user facilities are not required to report device malfunctions that would likely cause or contribute to death or serious injury if the malfunction were to recur but may voluntarily report such malfunctions through MedWatch, the FDA’s Safety Information and Adverse Event Reporting Program.

Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:

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International sales of medical devices are subject to foreign government regulations, which may vary substantially from country to country.

In order to maintain the right to affix the CE Mark to sell medical devices in the European Union, periodic surveillance audits of the company premises and, if needed, at major subcontractors’ premises must to be carried out by a Notified Body.

Notified Body.

In addition, all manufacturers placing medical devices into the market in the EU must comply with the EU medical device vigilance system.

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Our advertising for our products in the United States is subject to federal truth-in-advertising laws enforced by the Federal Trade Commission (“FTC”), as well as comparable state consumer protection laws.

Under the Federal Trade Commission Act, or FTC Act, the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce;

Under the Federal Trade Commission Act (“FTC Act”), the FTC is empowered, among other things, to (a) prevent unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce;

(b) seek monetary redress and other relief for conduct injurious to consumers;

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● The Civil Monetary Penalties Law , which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program;

● The HIPAA imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters;

● The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for executing a scheme to defraud any health care benefit program or making false statements relating to health care matters;

● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, and its implementing regulations, also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

● The federal transparency requirements under the Physician Payments Sunshine Act require manufacturers of FDA-approved drugs, devices, biologics and medical supplies covered by Medicare or Medicaid to report, on an annual basis, to the Center for Medicare and Medicaid Services (“CMS”) information related to payments and other transfers of value to physicians, certain advanced non-physician healthcare practitioners, and teaching hospitals or to entities or individuals at the request of, or designated on behalf of, such physicians, non-physician healthcare practitioners, and teaching hospitals as well as certain ownership and investment interests held by physicians and their immediate family members;

healthcare practitioners, and teaching hospitals as well as certain ownership and investment interests held by physicians and their immediate family members;

● Analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by nongovernmental third-party payors, including private insurers.

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Such service providers are called "Business Associates." Under HIPAA, as amended by the HITECH Act, HHS has issued regulations to protect the privacy and security of PHI used or disclosed by Covered Entities and Business Associates.

HIPAA also regulates and standardizes the codes, formats and identifiers used in certain

healthcare transactions and standardization of identifiers for health plans and providers, for example insurance billing.

HIPAA also regulates and standardizes the codes, formats and identifiers used in certain healthcare transactions and standardization of identifiers for health plans and providers, for example insurance billing.

Any non-compliance with HIPAA and HITECH and related penalties, could adversely impact our business.

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A single breach incident can violate multiple requirements.

Additionally, a person who knowingly obtains or discloses PHI in violation of HIPAA may face a criminal penalties (including fines and imprisonment), which increase if the wrongful conduct involves false pretenses or the intent to sell, transfer or use PHI for commercial advantage, personal gain or malicious harm.

Additionally, a person who knowingly obtains or discloses PHI in violation of HIPAA may face criminal penalties (including fines and imprisonment), which increase if the wrongful conduct involves false pretenses or the intent

to sell, transfer or use PHI for commercial advantage, personal gain or malicious harm.

Covered Entities are also subject to enforcement by state Attorneys General who were given authority to enforce HIPAA.

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The California Confidentiality of Medical Information Act (“CMIA”) imposes restrictive requirements regulating the use and disclosure of health information and other personally identifiable information.

The California Consumer Privacy Act of 2018 (the “CCPA”) went into effect January 1, 2020.

The California Consumer Privacy Act of 2018 (“CCPA”) went into effect January 1, 2020.

The CCPA, among other things, creates new data privacy obligations for covered companies and provides new privacy rights to California residents, including the right to opt out of certain disclosures of their information.

It also creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling certain personal information.

The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches which has led to an increase data breach litigation.

The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches which has led to an increase in data breach litigation.

Although the law includes limited exceptions, including for PHI maintained by a covered entity or business associate under HIPAA and medical information maintained by healthcare providers under the CMIA, it may regulate or impact our processing of personal information depending on the context.

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The CPRA imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data and expands the application of the CCPA to all human resources personal information of California-based employees.

It also created a new regulatory entity, the California Privacy Protection Agency data protection agency, which is authorized to issue substantive regulations under the CPRA and is expected to result in increased privacy and information

security enforcement.

Other states have implemented similar laws protecting identifiable health and personal information, and most such laws differ from each other in significant ways and may not be preempted by HIPAA, thus complicating compliance efforts.

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In the European Union, increasingly stringent data protection and privacy rules that have and will continue to have substantial impact on the use of personal and patient data across the healthcare industry became stronger in May 2018.

The GDPR applies across the European Union and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

The General Data Protection Regulation (“GDPR”) applies across the European Union and includes, among other things, a requirement for prompt notice of data breaches to data subjects and supervisory authorities in certain circumstances and significant fines for non-compliance.

The GDPR fine framework can be up to 20 million euros, or up to 4% of our total global turnover of the preceding fiscal year, whichever is higher.

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providing expanded disclosures about how their personal data will be used;

higher standards for organizations to demonstrate that they have obtained valid consent or have another legal basis in place to justify their data processing activities;

higher standards for organizations

to demonstrate that they have obtained valid consent or have another legal basis in place to justify their data processing activities;

the obligation to appoint data protection officers in certain circumstances;

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Facebook (Case C-311/18), called Schrems II.

This decision (a) called into question commonly relied upon data transfer mechanisms as between the European Union member states and the United States (such as the Standard Contractual Clauses) and (b) invalidateds the EU-U.S.

Privacy Shield on which many companies had relied as an acceptable mechanism for transferring such data from the EU to the United States.

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Intellectual Property

Patent applications

Granted Patents

On May 8, 2011, certain of our founders filed a Patent Cooperation Treaty (“PCT”) Application No.

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We believe these early patents represent critical intellectual property recognition and a significant initial validation of our intellectual property efforts.

Further, a corresponding European patent was granted to us in May 2016, as European patent No.

2569622 for testing of fluids through an audio jack connection.

An additional corresponding patent was granted in Israel in April 2016.

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Additional patent applications are in the process of being discussed and developed, and we believe that we have a rich potential pipeline of future technologies that we intend to develop.

For example, we are further seeking to develop and protect new intellectual property around future generations of our hardware and software with the goal of achieving enhanced functionality, user interface, data usability, cyber protection, and artificial intelligence enhancement.

In early 2022, we acquired Physimax and acquired the following patent – US 10,709,374 B2 titled “System and Method for Assessment of Musculoskeletal Profile of a Target Individual.”

This patent was also submitted as EP application #19767795.8 on the 05/03/2019 and is currently pending.

Design patents and patent applications on the Dario Blood Glucose Monitoring System

To further protect our market distinction and branding for the Dario Blood Glucose Monitoring System, three U.S.

Design Applications have been filed and granted covering the glucose meter, the cartridge, and connection dongle.

At least some of these applications were granted and registered in the United States, as well as, Canada, Europe, and Hong Kong.

Trademark applications

We have also filed several families of trademark applications covering the “Dario” name (wordmark), the Dario name and logo (logo), the Dario logo alone (logo), the DARIO-LITE wordmark, the LABSTYLE INNOVATIONS wordmark, the DARIOHEALTH wordmark, and the DARIOHEALTH logo.

In particular, the “Dario” wordmark is registered as a trademark in Australia, Canada, China, Costa Rica, United States, Israel, Hong Kong, South Africa, Japan,

Costa Rica, Europe, Israel, Korea, Mexico, New Zealand, Panama and Russia.

The “DARIOHEALTH” wordmark is registered as a trademark in the United States, Canada, China and India.

Upright also added the following trademarks to our list:

UPRIGHT, UPRIGHT GO – registered in the US, AU and EM, and UPRIGHT DASHBOARD, UPRIGHT DESKTOP, UPRIGHT GO 2, UPRIGHT POSTURE IS WITHING REACH – registered in the U.S.

Utility Models

We have been granted Utility Models for our core invention in Japan.

Other intangible assets

As the number of Dario users grows, an ever-growing amount of data is being collected from diabetic patients, including their blood sugar levels, meal compositions, routines, physical exercise (intensity and duration) as well as many other factors, and lately also blood pressure data, which are all useful for creating meaningful correlations between these factors and insulin use.

We expect that this database will be highly valuable and may be capitalized in many ways.

The accumulation of this type of know-how and related algorithms are protected as trade secrets using specialized confidentiality protocols.

Twill Intellectual Property

Granted Patents

As a result of our acquisition of Twill, we have acquired the following patents:

On October 27, 2020, the United States Patent Office issued Patent No.

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When one or more of the plurality of conditions are determined not as satisfied, the process includes generating a prompt designed to elicit, from the user, a response specific to satisfying the missing conditions.”

There are also pending associated patent applications filed in the European Patent Office (Application 18835438.5), Canada (Application 3070229), and Hong Kong (Application 620200109481).

On February 7, 2023, the United States Patent Office issued Patent No.

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The abstract contained in the patent award describes this patent as “A dynamic interactive network system provides an online service and social community for engaging, learning, and training skills for happiness.

The system includes a processor and memory storing instructions which when executed by the processor configure the processor to provide the online service.

The system includes a processor and memory storing instructions

which when executed by the processor configure the processor to provide the online service.

The instructions further configure the processor to provide tracks including activities, provide an initial happiness level and a track to a user based on a self-assessment completed by the user upon signing up, monitor progress of the user based on self-assessments periodically completed by the user, modify the track based on the self-assessments, suggest followers to the user from the users whose profiles match the profile of the user in terms of demographics, psychographics, and rating of the users on the online service, and generate a happiness graph for the user that correlates the activities and the followers with their impact on happiness level of the user.”

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The system/method further includes retrieving of a pair of sequential user response and follow-up prompt from the database, displaying user-selectable ratings, each rating designating a respectively different quality to the follow-up prompt, receiving selection of a rating and a related comment, and associating the selection and the comment to the follow-up prompt.

There are also pending associated patent applications filed in the European Patent Office (Application 19847959.4), Canada (Application 3109113).

Design patents

To further protect our market distinction and branding for the Dario Blood Glucose Monitoring System, three U.S.

Design Applications have been filed and granted covering:

D706935, the glucose meter;

D7066934, the cartridge;

and D706933, connection dongle.

As a result of our acquisition of Upright, we have acquired the following two design patents:

D852656, the Upright wearable device, and D958784, the wearable posture detection device.

We have filed several families of trademark applications covering the “Dario” name (wordmark), the Dario name and logo, the Dario logo alone, the DARIO-LITE wordmark, the LABSTYLE INNOVATIONS wordmark, the DARIOHEALTH wordmark, and the DARIOHEALTH logo.

In particular, DARIO (word mark, name and logo), is registered in the United States, China, the EU, Canada, Hong Kong, Australia, Brazil, and is also registered as a WO (WIPO registration).

DARIOHEALTH, is registered in the United States, China, the EU, Canada, Hong Kong, Australia, Brazil, Israel, Japan, India, and is also registered as a WO.

DARIO-LITE, is registered in the United States, Brazil, and

DARIO MOVE, DARIO ELEVATE, DARIO CONNECT, DARIO MIND, DARIO LC, DARIO EVOLVE, DARIO ONE, are registered in the United States.

DARIO ENGAGE is registered in the EU.

As a result of our acquisition of Upright, we have acquired the following trademarks:

UPRIGHT, UPRIGHT GO, are registered in the Unites States, China, England, and the EU.

UPRIGHT GO 2 is registered in the Unites States.

As a result of our acquisition of Twill, we have acquired the following trademarks:

HAPPIFY, is registered in the United States, China, England, the EU, India, and as a WO.

TWILL, is registered in China, England, the EU, India, Australia, Brazil, Canada, Japan and as a WO.

ASPIRO, is registered in China, England, the EU, India, Australia, Brazil, Canada, Japan, and as a WO.

THERAPEUTIC MEDIA and Circular Design (Talk Bubble Design), are registered in the United States.

Patent Applications

On June 17, 2021, PCT/IL2021/050739 was filed for the WO, titled POSTURE DETECTION DEVICE AND SYSTEM.

On December 8, 2021, patent application 2022/0181004 was filed in the United States Patent office.

Titled “ CUSTOMIZABLE THERAPY SYSTEM AND PROCESS”, the abstract for this application describes as “The present invention is directed to a computing system and a process carried out by such system for providing a therapy session personalized to the circumstances of the user.

The therapy session includes an audio component that is automatically generated by an algorithm that makes a voice seem to be that of an actual person.

In a similar way, a video component to the therapy session may also be presented.”

Titled “ CUSTOMIZABLE THERAPY SYSTEM AND PROCESS”,

On October 12, 2022, patent application 2023/0111078 was filed in the United States Patent office.

Titled “DISTRIBUTED NETWORK FOR MODIFIABLE INTERACTIVE SESSIONS AND ADHERENCE ENHANCEMENT THEREOF ”.

On October 12, 2022, patent application 2023/0112522 was filed in the United States Patent office.

Titled “PHARMACEUTICAL ADMINISTRATION TRACKING AND TREATMENT COMPLIANCE SYSTEM ”.

On October 12, 2022, patent application 20230112908 was filed in the United States Patent office.

Titled “Modifiable pharmaceutical protocol for migraine treatment and assessment of drug efficacy thereof ”.

On January 26, 2022, patent application 2022/0237709 was filed in the United States Patent office.

Titled “ SENSOR TRACKING BASED PATIENT SOCIAL CONTENT SYSTEM”, the abstract for this application describes as “A computing system that includes a server, the system functions as a patient social content system (PSCS) which, among other functions, provides content to a patient/user.

A device with a network connection to the computing system permits the patient to provide information to the computing system.

In addition, one or more sensors are configured to detect changes in various physical parameters relevant to the patient.

Electrical signals from the sensors are conveyed to the computing system so that the computing system is aware of changes in physical parameters of the patient.

Based on the changed physical parameters of the patient, the computing system provides different content to the user that is relevant to the changes.

Overall, processes carried out by the system establish and maintain a patient social content system that utilizes tracking data received from one or more sensors.”.

Associated applications have been filed in the WIPO (Application No.PCT/US 2022/046487 and EPO (Application No.

Granted Trademarks

Registration No.

Registration Date

Therapeutic Media

Circular Design (Talk Bubble Design)

HAPPIFY HEALTH

Madrid Protocol

1738488 (AU,UK)

As of March 3, 2025, we had 196 full-time employees and 6 part-time employees.

Titled “ SENSOR TRACKING BASED PATIENT SOCIAL CONTENT SYSTEM”.

On April 19, 2023, patent application 20230260423 was filed in the United States Patent office.

Titled “ Systems and methods for managing dynamic user interactions with online services for enhancing mental health of users”.

On August 15, 2023, patent application 20230385555 was filed in the United States Patent office.

Titled “ Systems and methods for dynamic user interaction for improving mental health”.

Other intangible assets

As the number of our users grows, an ever-growing amount of data is being collected from patients, including their blood sugar levels, meal compositions, routines, physical exercise (intensity and duration) as well as many other factors, and lately also blood pressure data, which are all useful for creating meaningful correlations between these factors and insulin use.

We expect that this database will be highly valuable and may be capitalized in many ways.

The accumulation of this type of know-how and related algorithms are protected as trade secrets using specialized confidentiality protocols.

As of March 11, 2026, we had 160 full-time employees and five part-time employees.

We have employment agreements with our four executive officers.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business