What changed in this filing

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Item 1. Business

2023-03-09 compared with 2022-03-22 · 361 added, 231 removed, 385 unchanged (61% of the section changed)

We are revolutionizing how people with chronic conditions manage their health through the innovation of a new category of digital health:

Dario is revolutionizing how people with chronic conditions manage their health through the innovation of a new category of digital health:

Digital Therapeutics as a Service (“DTaaS”).

We believe that our innovative approach to digital therapeutics disrupts the traditional provider-centered system of health care delivery by offering user-centric care that is continuous, customized and multi-condition.

We believe that our innovative approach to digital therapeutics disrupts the traditional provider-centered system of healthcare delivery by offering user-centric care that is continuous, customized supportive of better overall health.

Our solutions combine the power of technologies and behavior science to make better health accessible, affordable, and easy for all by solving for what people need, when and where they want it, with hyper-personalized care that is always connected – to services, devices, and people – and delivered continuously.

This is how we deliver meaningful and sustainable results that result in measurable value for all stakeholders, supporting the full transformation of health care into a more effective and affordable ecosystem.

Market Environment

The United States health care industry is becoming increasingly inefficient, incurring higher, unsustainable health care costs while the chronic conditions that it seeks to address continue to worsen.

According to the Centers of Medicare and Medicaid Services (CMS), the U.S.

spent $4.1 trillion on health care in 2020, with 75% of the costs attributed to care for chronic conditions.

We believe that addressing the cost challenges in chronic condition management will require three main shifts.

First, the market must shift from a provider-centric approach to a consumer centric approach, embracing the transformative effects of consumerization as a means to engage more patients in their own treatment to scale effective chronic condition management.

This consumerization of health care will change how people experience care, create new opportunities to engage people and help them change their behaviors for better health and lower cost of care.

Second, the digitalization of health will enable scale by connecting patients to health care professionals and payers, giving patients access to care for their health between provider visits and shifting healthcare from episodic to continuous care.

Telehealth addresses the synchronous portion of the problem, while digital health provides continuous support at scale.

Finally, value-driven care should become the standard.

In fact, performance-based models are already becoming a reality as the industry reckons with unsustainable costs and growing demands for transparency, creating pressure on stakeholders to find solutions that will address poor health and lower costs of care.

Our solutions are proven to drive savings for health plans and employers by improving the health of their populations.

We began as a direct-to-consumer digital therapeutics company, solving first for the problem of how to engage users and support behavior change to improve clinical outcomes in diabetes.

In the last two years, we made two strategic shifts to transform our business:

first, we significantly expanded commercial growth opportunities by adding a business-to-business product (B2B) and a commercial team alongside the legacy direct-to-consumer channel.

In addition, we began targeting three traditional health business verticals – health plans, employers, and provider groups.

As a result, we believe that our new B2B business now leverages our consumer-centric capabilities as a competitive advantage.

Second, we transitioned from a single condition platform to a multi-condition platform, creating a robust suite of solutions to address the five most commonly co-occurring and expensive chronic conditions, which are also representative of some of the most sought-after digital health solutions:

Beginning in 2020, Dario enacted a strategic shift to transform the business model by deploying a business-to-business-to-consumer (“B2B2C”) approach, leveraging the strengths of our consumer solution platform to enable commercial growth opportunities in traditional health business channels by selling to health plans and employers.

At the same time, we expanded from a single-condition platform to a multi-condition platform, creating a robust suite of solutions to address the five most commonly co-occurring, behaviorally driven, and expensive chronic conditions, which are also representative of some of the most sought-after digital health solutions:

diabetes, hypertension, pre-diabetes/weight management, musculoskeletal and behavioral health.

After building weight loss and hypertension management into the legacy diabetes platform, we made three acquisitions in order to expand into musculoskeletal and behavioral health.

Our acquisition of Upright Technologies Ltd.

(“Upright”) in early 2021 and Physimax in early 2022 enables our musculoskeletal (“MSK”) solutions – “Dario Move.”, our digital behavioral health capabilities were secured through the acquisition of PsyInnovations, Inc.

(dba wayForward) in mid-2021.

We believe a key success factor is our ability to integrate multiple chronic conditions into a single digital therapeutics platform, the “Dario One.” During 2021 we successfully won contracts in all three B2B business segments, including several contracts for Dario One, creating a compounding effect as more members enroll and many in multiple programs.

The combination of moving from direct-to-consumer to the enterprise business market (B2B2C) and expanding from a single condition to multi condition platform, created multiple commercial growth engines as well as a multiplying impact that we believe will improve our financial profile by increasing potential revenue per account and per user.

After building weight loss and hypertension management into the legacy diabetes platform, we made three acquisitions in order to expand into musculoskeletal (“MSK”) and behavioral health (“BH”).

In that regard, we acquired Upright Technologies Ltd.

(“Upright”), PsyInnovations Inc.

(“PsyInnovations”) and Physimax Technology assets to expand into the fields of MSK and BH .

Our approach to integrating all solutions into one digital therapeutics platform follows the “best-of-suite” offering design principal which provides the user one place to monitor all identified chronic conditions and to deliver a seamless user experience for commonly co-occurring chronic conditions..

These two shifts led to the rapid expansion of our B2B2C business over the last two years and positioned the company for success in commercial markets.

We continue to achieve key benchmarks as we rapidly scale our B2B2C model, including more than 100 total signed contracts as of today and the shift in our commercial pipeline where more

than 50% of the contracts signed in the second half of 2022 are for multi-chronic solutions.

We believe we have a unique and defensible position in the market thanks to our unique solution origin in consumer markets.

We continue to generate a significant number of clinical publications.

In that regard, we the have published 38 real world data studies with total of 10 generated in 2022, and several more already planned for 2023.

Recent Developments

Agreement with a Leading Employer Benefits Brokerage

In December 2021, we announced that we entered into a strategic partnership with a leading employer benefits brokerage (the “Partner”) to sell its digital therapeutic solutions for diabetes, hypertension and musculoskeletal health as part of a new premier employee health benefits product for small businesses.

The product has been made available to the Partner's more than 2,300 clients since early 2022.

Employer Contracts and Health Providers

Dario closed 2021 with a total of 54 new contracts in its first full year of selling digital therapeutics in the business-to-business market.

We have a range of health plans, providers and employers taking advantage of our digital therapeutics platform designed to address the most common chronic conditions:

diabetes, hypertension, weight management, musculoskeletal, and behavioral health.

In January 2022, we announced two new contracts with a large U.S.

northeast regional employer in the finance industry set to deploy the Company's full suite of solutions, and a northeast regional employer in the food industry contracted to deploy the Company's digital therapeutic solution for diabetes.

In January 2022, we also announced that we have contracted with a large regional health plan provider to deliver its digital therapeutic solution for diabetes for eligible U.S.

Medicaid members in and around the mid-Atlantic region.

The contract is expected to contribute to revenue beginning in the second quarter of 2022.

In addition, in February 2022, we announced several new contracts to deliver the Company’s digital therapeutics solutions for four new employers.

The new accounts are expected to launch during the first and second quarters of 2022.

The new clients include a northeast regional employer contracted for the Company's diabetes solution and three employers - including two educational organizations and a regional professional services firm - launching with the Company's behavioral health solution.

In March 2022, we also announced new agreements with a regional employer and a regional provider.

The new employer client will deploy Dario's digital behavioral solution to improve access to outcomes-based care, and the new provider contract will deliver both diabetes and hypertension solutions to patients.

The contracts are expected to launch in the second quarter of 2022.

Agreement with Physimax

In January 2022, we announced that we have entered into an agreement to purchase all of the right, title and interest in certain assets of Physimax Technologies Ltd.

("Physimax"), a leading provider of computer vision (CV) technology for Musculoskeletal (MSK) functional screening and predictive risk of injury assessment.

Physimax's technology is currently in commercial use by NBA and NFL teams, the U.S.

military and health care facilities specializing in orthopedic care.

The closing of the acquisition of Physimax's assets is subject to customary closing conditions, including the approval of the Israeli Innovation Authority.

The technology enables automated MSK and injury risk screenings with validated accuracy and Physimax's Artificial Intelligence (AI) engine generates evidence-based personal training programs based on the user's objective scoring outcome to aid in effective injury prevention and recovery.

Physimax's unique technology is validated by a professional motion lab as well as industry experts and proven to be comparable to trained human professionals.

In consideration for the acquisition of Physimax's assets, the Company agreed to issue up to 256,660

shares of its common stock, subject to a lock up period, plus a cash payment of $500,000, as well as agreed to assume certain liabilities in an approximate amount of $1,020,000.

Agreement with Sanofi U.S.

In March 2022, we announced our entering into a strategic agreement with Sanofi U.S., an innovative global healthcare company.

The multi-year, $30 million-dollar agreement, which is subject to certain contingencies, will help accelerate commercial adoption of Dario's full suite of digital therapeutics and drive the expansion of digital health solutions on the Dario platform.

Dario and Sanofi will collaborate on promoting the Dario multi-condition digital therapeutics solution, significantly increasing Dario's sales reach in the health plan market and selectively in the employer channel.

In addition, the agreement calls for Dario and Sanofi to develop new or enhanced solutions leveraging the Dario platform, and for the parties to generate robust evidence to support future commercialization in the health plan channel.

Competitive Advantages

Our competitive advantage is driven by several unique capabilities, including:

Consumer-centric design.

Integration of Dexcom CGM Data

We collaborated with Dexcom to integrate the data from its market-leading Continuous Glucose Monitoring (“CGMs)” technology, which uses a small, wearable sensor to continuously measure and send glucose levels to a receiver or smart device to enable better real-time decision making for people living with diabetes, into our multi-chronic condition platform.

This partnership, signed in early 2023, enables the integration of data from Dexcom CGMs directly into our metabolic solution, making it easy for people using the wearable device to benefit from our highly personalized support.

Our 2022 agreement with Sanofi continues to evolve after the first year of our agreement across all three pillars of the agreement.

First, our co-promotion efforts are yielding a healthy pipeline of health plans and Pharmacy Benefit Managers (“PBMs”), and we have several opportunities in or close to contracting.

Second, our product development has yielded several new features currently in beta testing with our consumer membership.

We expect that these features will be released more broadly to the market in the spring of 2023.

Third and finally, we are preparing our first two research studies with Sanofi with the release of data expected in the summer of 2023.

Director and Officers

In January 2023, we announced that we executed a Termination of Employment and Separation with Dror Bacher, our prior Chief Operating Officer, pursuant to which Mr.

Bacher’s position as Chief Operating Officer was terminated with immediate effect.

We have retained Mr.

Bacher as a member of our advisory board.

In February 2023, on the recommendation of the Nominating Committee of the Board of Directors, we expanded the Board by one seat and appointed Jon Kaplan as a member of the Board.

Market Landscape

The traditional healthcare industry is siloed and service-centric, and it is difficult for people to access care and support, while the healthcare experience itself remains cumbersome and disconnected.

The future of health care is being shaped by digital health technologies that are rapidly becoming more important as access to traditional health care for the management of whole health becomes more difficult.

As a direct-to-consumer pioneer, we presciently identified shifting healthcare consumer behaviors early and designed solutions with the intent of enabling users with easy-to-use technologies that support adoption and engagement.

Our members demanded ease of access and personalization, generally absent in health care but a standard in other consumer service experiences, and our unique approach significantly exceeds those expectations with excellent ratings from our members.

Commercial digital health solutions currently perform poorly in this area, which leads to low engagement and weak outcomes.

As we expand our commercial business, we believe our consumer-centric solutions position us as a leader in digital health through a best-of-suite platform proven to deliver the experience people are demanding.

This enables our service-oriented business model by delivering the engagement our clients demand and yields a stable form of revenue through an Annual Recurring Revenue (“ARR”) model.

Longer term, as the market for digital health solutions faces economic pressures, we believe our consumer origins arm has several natural advantages that will help propel our growth and cement our leadership position.

First, we amassed a trove of billions of data points from our consumer engagement and dozens of clinical publications including multiyear studies with approximately 50,000 participants.

Second, we built what we believe is the best-in-market clinical platform built with a focus on the overlapping chronic health needs present in our user base.

This shift from a single condition platform to a multi-condition platform enables our best-of-suite approach.

Two years post-shift from our business-to-consumer into a B2B2C business model, we believe that the financial impacts are validating our growth and DTaaS theses.

Our pro-forma gross profit for the quarter ended December 31, 2022, excluding acquisition related amortizations, has improved to 50% of revenues in 2022 compared to 39% of revenues in 2021.

In 2022, our commercial revenue exceeded our consumer revenue.

Competitive Strengths

We believe that we are proving the value of our solutions as enterprise business sales continue to grow.

With more than 100 signed contracts to date, we have solid evidence on the key differentiators that lead to new business opportunities:

a consumer-friendly approach that drives engagement;

deep integration capabilities;

and best-in-class clinical outcomes.

Consumer Friendly Approach

Most digital health solutions are built to address the needs of a business and then sold directly to the business, bypassing the difficult step of achieving consumer buy-in with respect to the product.

Our experience as a direct-to-consumer company now leverages those insights to drive B2B2C commercial growth by working with health plans, employers, and provider groups and providing them a solution that their end users are more likely to utilize.

Our experience as a direct-to-consumer company now leverages those insights to drive B2B2C commercial growth by working with health plans, employers, and provider groups and providing them with a solution that their end users are more likely to utilize.

Our current and potential customers recognize that consumer engagement insights are critical to success, and they are prioritizing solutions with more of a consumer-focused experience.

Hyper-personalization.

Unlike other digital health solutions, we personalize the user journey to anticipate and adapt to each individual’s unique circumstances, preferences and changes over time.

Our solution has a 40% member enrollment rate.

Our customized, dynamic user journeys are delivered by our artificial intelligence (“AI”)-driven journey engine which personalizes user experience across a range of factors including timing, tone, channel, content, frequency and intervention.

We believe that this creates an adherence to our solutions that leads to an 80% year-over-year retention rate for consumers on our platform and the ability to sustain clinical improvements for more than two years, as demonstrated in our published studies as discussed more fully below.

Therapeutic value at scale.

The digitization of health care has created an ecosystem of access points and point solutions that are largely disconnected, creating waste and inefficiency without sustainable value.

We believe that our unique approach to connected and continuous health care through the use of our single integrated multi-condition platform leads to superior engagement and retention, reduced costs, and ultimately, improved user health that can be delivered at scale.

These advantages combine to ensure that our users have a better overall experience, with stronger engagement, superior clinical and financial outcomes and a simplified integrated platform that addresses the conditions that matter most to our customers and users.

We believe that impaired user engagement in competitor solutions could also drive enterprise customers to switch to us.

Deep Integration Capabilities

Our platform was designed with a flexible, open-framework that yields multi-faceted benefits for our members and partners including their clinical health and user experience.

Our experience is a best of suite platform that leverages four points of integration to drive a connected, dynamic and adaptive user journey:

● User data is being captured and integrated across the experience, driving a personalized member experience across applications.

● User interface, including mobile applications, have been integrated to support a unified member experience.

● Clinical integration informs recommendations across conditions.

● This is all supported by a fully integrated coaching experience which provides one coach who supports the member across their entire journey.

The native integration of data across our solutions, providing a single view of a member data across all conditions and interactions, fuels our consumer-centric approach to engagement and leads to a more seamless user experience.

Our ability to allow integrations at the platform-level, easily allowing for the ingestion and exportation of data, also positions us as uniquely able to support the more connected healthcare experience that members and our partners increasingly demand.

The recent integration of Dexcom CGM data into our platform is one example of the utility of our open-platform, positioning us as an attractive choice for clients and partners interested in building towards the future state of digital health.

Clinical Outcomes

We believe that we lead the digital therapeutic market in published outcomes with 38 studies across our suite of solutions, including the first clinical research demonstrating the positive impact of managing multiple chronic conditions with one digital health solution.

Our ability to use large, real-world, longitudinal data-sets gives us a natural advantage in the scope and type of studies that can be conducted compared to competitors.

This capability enables one of the unique elements of our partnership with Sanofi, allowing our data to be consumed by a third party for independent analysis and eventual publication in a study in mid-2023.

Our Product Offering

Our user-centric software platform integrates digital therapeutics, coaching, professional human support and medical devices to drive superior clinical and financial outcomes.

Our suite of offerings is modular, allowing for enterprise clients to purchase one or more of our chronic condition management solutions, while enjoying the same best-in-class experience supported by our behavior change journey engine so our partners can be confident in achieving sustainable outcomes and value.

Our suite of digital offerings include:

Our best-of-suite suite of offerings is modular, allowing for enterprise clients to purchase one or more of our chronic condition management solutions, while enjoying the same best-in-class experience supported by our behavior change journey engine so our partners can be confident in achieving sustainable outcomes and value.

Our suite of digital offerings includes:

Dario Metabolic (“Dario Evolve”)

Dario’s metabolic solutions are designed to address some of the most commonly co-occurring metabolic health needs - diabetes, hypertension, and weight management - through a combination of software, our smartphone-connected tools,

interaction with live coaches, and real-time data analysis to help inform and educate users of the relationship between their behaviors and their health outcomes to drive changes that last.

Our metabolic solutions are designed to address some of the most commonly co-occurring metabolic health needs - diabetes, pre-diabetes, hypertension, and weight management - through a combination of software, our smartphone-connected tools, interaction with live coaches, and real-time data analysis to help inform and educate users of the relationship between their behaviors and their health outcomes to drive changes that last.

Dario Musculoskeletal (“Dario Move”)

Our unique approach prevents and treats the most common MSK conditions, including chronic pain, by dealing with the cause and empowers users to create behavioral change.

Our unique approach addresses the most common MSK conditions, including chronic pain, by dealing with the cause and empowers users to create behavioral change.

Dario Move’s digital physical therapy programs and posture training help people improve strength and mobility by using a combination of software, wearable biofeedback sensors, and coaching to drive sustainable improvements in musculoskeletal health.

The inclusion of posture training in the solution supports ongoing engagement in support of prevention and maintenance outside of an exercise therapy program.

Dario Behavioral Health (“Dario Elevate”)

Dario’s behavioral health solution optimizes access to evidence-based care by using an AI-driven screener to triage users and connect them to the most appropriate support across a wide range of mental health needs, including our integrated digital tools and coaching, giving patients a seamless path to proven mental health support.

Our behavioral health solution optimizes access to evidence-based care by using an AI-driven screener to triage users and connect them to the most appropriate support across a wide range of mental health needs, including our integrated digital tools and coaching, giving users a seamless path to proven mental health support.

Dario Full Suite (“Dario One”)

Dario’s full suite of chronic condition management solutions offers the maximum benefit for our partners with a completely seamless and holistic approach to managing chronic conditions.

In addition to a better member experience, our partners deploying Dario One enjoy several benefits from purchasing the entire suite of solutions:

Our full suite of chronic condition management solutions offers the maximum benefit for our partners with a completely seamless and holistic approach to managing chronic conditions.

In addition to a better unified member experience, our partners deploying Dario One enjoy several benefits from purchasing the entire suite of solutions:

better overall health as evidenced by recent research published by us;

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and a more affordable program launches due to lower costs of implementation.

Dario Health Solution Main Components

Users vary significantly in their interests and preferences, and unique user preferences also vary over time with respect to the optimal timing, tone, content, channel, frequency, and interventions required to produce sustained behavior change.

Dario’s Solution Main Components

Users’ interactions with devices, smartphones, coaches, providers, and third-party solutions must be personalized along these axes to ensure optimal engagement, retention, and outcomes.

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Key to our ability to accommodate user behavioral changes is our mature AI-driven user journey engine.

While several in-market solutions now integrate health signals across a range of categories to apply limited, nominal personalization, primarily in the form of nudges, our solution is informed by years of user experience data from over 223,000 users, enabling us to continually personalize and adapt user journeys themselves (and not just messages) over time.

While several in-market solutions now integrate health signals across a range of categories to apply limited, nominal personalization, primarily in the form of nudges, our solution is informed by years of user experience data from over 250,000 users that joined our chronic-condition platform, enabling us to continually personalize and adapt user journeys themselves (and not just messages) over time.

Our journey engine drives our multichannel targeted outreach and enrollment campaigns, informs specific recommendations around a range of categories such as diet, physical activity, self-care, coaching interventions, and provider engagement, and evolves in real time in response to the data exhaust from a user’s interaction with the care ecosystem.

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The engine is designed for integration and scale;

we add populations and conditions for which behaviors are primary drivers of outcomes, our engine becomes more adept at customizing a user’s evolving preferences and needs.

as we add populations and conditions for which behaviors are primary drivers of outcomes, our engine becomes more adept at customizing a user’s evolving preferences and needs.

Software Applications

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Our integrated, evidence-based digital tools and coaching help people learn proven techniques to better manage their emotional health.

DarioEngage and Coaching

Our member health is managed through our proprietary care management platform DarioEngage, an integrated experience from contracting through onboarding, data exchange, enrollment, outcomes, and reporting.

Regardless of which conditions or populations our customers select, and independent of whether they choose to deploy portions of their strategy through other partners, we present a unified application experience in DarioEngage to reporting that simplifies deployments, creates market-leading transparency, and accelerates and broadens user engagement.

DarioEngage also serves to support our coaching staff by providing a member-level view to help monitor progress and track escalations in real-time.

Our professional staff includes trained and certified health coaches who serve as a personal support for each member throughout their journey, and clinical experts who provide expert-level care when members need additional support.

Live Coaching

Live coaching is available as part of the Dario experience to give members a human point of contact for support and motivation, and also provide a level of accountability that is proven to help improve engagement and outcomes.

As an integrated component of our suite of solutions, our professionally trained and certified health coaches serve as a personal support for each member throughout their journey across all solutions and are able to connect members with clinical experts when members need additional support.

Our clinical coaches include Certified Diabetes Educators (“CDCES”), Registered Nurses, Pharmacists and Mental Health Clinicians who are able to assist members throughout their journey.

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● Biofeedback sensor device

Sales and Marketing

In 2021, we invested in building a robust U.S.

commercial team with deep experience in the health care industry to sell into the three key industry segments:

health plans, employers, and providers.

Dario’s sales teams are aligned to commercial channels and charged with maximizing revenue by selling multiple product lines in each channel.

Dario’s marketing resources are focused on three key objectives:

first, engage new consumers on the platform to provide early feedback on new and enhanced solutions;

second, engage eligible individuals with our services as part of an enterprise client population;

and third, attract new enterprise clients across all three sales segments.

Our Commercial Channels

We are focusing the go-forward business strategy around three key market opportunities:

direct sales to employers and payers and partnerships with the ability to multiply our growth opportunities.

We believe that our scalable business model selling digital therapeutics as a service through multi-year contracting relationships establishes a pipeline of ARR and has the potential to improve our gross margins over time.

Our software solutions are sold across a range of channels to create multiple growth engines and support rapid adoption across all segments of the market.

Our integrated product suite is designed to address a common and growing sentiment from enterprise customers expressing frustration with the large number of condition-specific solutions, lack of transparency, lackluster results and poor member experiences.

Our software solutions align to meet the pain points across the three key buyer segments – health plans, employers, and providers – while also delivering value to strategic partners through our differentiated approach in the market.

Finally, our consumer-centric legacy remans a key component of our commercial strategy, bolstering our ongoing solution development by serving as proving grounds for new services and product enhancements.

Our integrated solution aligns with these key buyer pain points and is proven to deliver value to strategic partners through our differentiated approach in the market.

Finally, our consumer-centric legacy remains a key component of our commercial strategy, bolstering our ongoing solution development by serving as an innovation laboratory for new services and product enhancements.

Health Plans :

Although health plans represent the longest and most complex purchasing cycle across our client base, these contracts often represent sizeable opportunities as they typically offer much larger potential member populations.

We currently have two live contracts with health plans, one a regional payer and one a large national plan, with several additional plans in negotiation and contracting at present day.

We currently have three live contracts with health plans, two are regional payers and one is a large national plan, with several additional plans in negotiation and contracting at present day.

Our most robust growth in 2022 came from the employer market, a key buyer to help demonstrate our ability to deliver results.

Today, we have several dozen employer populations actively on our platform, and growth of our employer pipeline continues to grow and mature.

The Centers for Medicare and Medicaid released additional proposed Current Procedural Terminology (“CPT”) codes for remote therapeutics in 2021, expanding our ability to support providers using our solutions to provide Remote Patient Monitoring (RPM) services.

We won provider RPM contracts from several large regional practices in 2021 and continue to see pipeline growth thanks to the growing regulatory acceptance of digital health as form of care delivery, with several practices actively in the negotiation and contracting phase.

Today, we have approximately 80 employer populations actively on our platform, and growth of our employer pipeline continues to grow and mature.

Partnerships:

As part of our strategy for rapid growth, strategic partnerships play a key role in helping to expand our reach across markets quickly and efficiently.

One such significant partnership agreement to come to fruition in early 2022 is our collaboration with Sanofi, a global leader in health care.

The multi-year, $30 million-dollar agreement, as described more fully below, will help accelerate commercial adoption of our full suite of digital therapeutics through the promotion of our solutions in Sanofi sales channels and the collaborative development of new products.

Strategic partnerships play a key role in helping to expand our reach across markets quickly and efficiently.

Our consumer-centric platform, the rate at which we have evolved our product, added and integrated solutions and provided product improvements and ability to easily share data and support a multitude of integrations makes Dario

an attractive choice of partner for many in the market.

One such significant partnership agreement is our collaboration with Sanofi, a global leader in health care, a relationship that resulted after an extensive search determined we are uniquely capable of providing the robust data and analytics required by Sanofi.

The multi-year, $30 million-dollar agreement, is helping to accelerate commercial adoption of our full suite of digital therapeutics through the promotion of our solutions in Sanofi’s sales channels and the collaborative development of new products.

We also entered into partner agreements with several large employer benefits platforms such as Virgin Health Pulse in 2021, helping expand our reach within the employer market.

In addition to our partnership with Sanofi, Dario is actively pursuing distribution partnerships in both the payer and employer verticals.

In 2022, we partnered with Solera to establish a payer channel through their large network of plans.

We also entered into partnership agreements with several large platforms such as Virgin Health Pulse, Alliant Insurance Services, and Vitality Group , helping expand our reach within the employer market.

Dario is actively pursuing new partnerships in both markets in 2023 to enhance our opportunities with a one-to-many approach.

Our ability to engage members and improve health begins with our consumer-centric approach, and this audience remains key to our commercialization at the enterprise client level.

Our direct-to-consumer channel continues to attract members to our platform and provides a neutral audience for testing and learning about our products.

Our direct-to-consumer channel continues to attract members to our platform and provides a neutral audience to test innovative product ideas, something traditional B2B companies are unable to do given limitations on commercial membership.

These insights inform both our AI-driven behavior change journey engine, helping continuously improve engagement and retention, and inform product design to ensure our solutions remain at the forefront of consumer expectations.

On February 28, 2022, we entered into an exclusive preferred partner, co-promotion, development collaboration and license agreement (the “Agreement”) with Sanofi for a term of five (5) years.

Pursuant to the Agreement, we and Sanofi will collaborate as preferred partners to co-promote certain of our products and services, including devices and accessories, and to develop new products and services based on insights derived from our data relating to the use of those devices and services.

In addition, we granted Sanofi a license to access and use certain of our data to derive insights from and improve our products or services, and Sanofi granted us a license under certain intellectual property of Sanofi for purpose of creating and promoting certain products and services in the United States.

On February 28, 2022, we entered into an exclusive preferred partner, co-promotion, development and license agreement (the “Agreement”) with Sanofi for a term of five (5) years.

Pursuant to the Agreement, we and Sanofi will co-promote certain of our products and services, including devices and accessories, and to develop new products and services based on insights derived from our data relating to the use of those devices and services.

In addition, we granted Sanofi a license to access and use certain of our data, and Sanofi granted us a license under certain intellectual property of Sanofi for purpose of developing and promoting certain products and services for Sanofi in the United States.

Pursuant to the Agreement, in consideration of the preferred co-promotion and development rights granted by us, Sanofi agreed to pay us an aggregate amount of up to $30 million over the initial term of the Agreement, consisting of (i) an upfront payment, (ii) annual compensation for development costs per annual development plans to be agreed upon annually and (iii) certain contingent milestone payments upon meeting certain net sales and enrollment rate milestones at any time during the term of the Agreement.

The Agreement also provides for us to make certain revenue sharing payments to Sanofi in a percentile beginning in the low double digits to low twentieth percentile of specified revenues upon qualifying sales through Sanofi introductions achieving a minimum revenue amount, and provided that the qualifying sales through Sanofi introductions remain above a specified percentage of total sales after year 3 of the collaboration.

Revenue sharing in the thirtieth percentile will apply with respect to new solutions or services developed under the collaboration.

Revenue sharing in the thirtieth percentile will apply with respect to new solutions or services developed under the agreement.

The Agreement has a term of five (5) years and may be renewed for a subsequent five (5) year term upon the mutual agreement of the parties.

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or (iv) by Sanofi if we fail to complete a development plan within nine (9) months of the Effective Date, or upon our change of control.

Our Growth Strategies

As a company with multiple product lines operating in several channels, we have multiple growth engines.

Furthermore, because we often bill on a per member per month basis, this enables recurring revenue that grows when users are enrolled into the platform.

The below key factors should have high impact on the business ability to grow.

Add customers across a range of markets and channels .

In 2021, we established a client footprint across all three key enterprise verticals – providers, employers, and health plans – with contracts representing a mix of our solutions.

Each additional contract not only increases revenues, but also the likelihood of attracting additional new customers as they recognize our solutions being adopted and trusted by peers and competitors.

With new and existing clients, we are also focused on expanding client solution contracts across product lines to increase our ability to maximize revenue per member through engagement in multiple condition management programs.

Increase the eligible populations within customers .

The expansion of our solution set to include MSK and behavioral health increases our ability to cover larger portions of our customers’ populations, thereby reducing the need for our customers to engage multiple vendors, and reducing their costs as compared to the alternative of partnering with multiple solutions to cover the conditions and categories that we cover on one single platform.

The addition of medical conditions on our platform in the future can also accelerate the eligible populations for our services.

Drive Engagement .

Our business model is predominantly a subscription model, where we charge per user engaged on the platform.

As our AI matures and as we deploy increasingly dynamic and adaptive personalization, we intend to engage a large portion of eligible populations, potentially driving increased revenue.

Optimize solutions for value .

Our customers primarily engage for 2 key reasons:

the opportunity for cost savings and our competitive advantage in breadth of conditions serviced and our AI technology.

Our pricing strategy is designed to deliver return on investment to our customers soon after engagement, and steadily over time.

As we evolve our solutions to deliver increased value to our users, we can offer customers value-based pricing models that can lead to greater revenue.

The onboarding of client populations across multiple product lines requires the ability to outreach and engage to large numbers of individuals in a coordinated and responsive manner.

We are focused on scaling operations to meet the rapid growth our of enterprise client member base by investing in platform and process technologies.

We also maintain supply agreements with commercial-scale manufacturers to produce our consumer devices, and owns the specialized equipment used to manufacture the Dario Blood Glucose Monitoring System.

Clinical Studies

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Dario reported an Average Reduction in Estimated HbA1C of 1.4% for High-Risk type 2 Diabetes Users.

Dario presented at the 77 th ADA session a study that was titled “Reducing A1C Levels in Individuals with High-Risk Diabetes Using the Mobile Glucose Meter Technology.” In the study Dario reported an average reduction in estimated HbA1C of 1.4% for high-risk type 2 Diabetes users.

We presented at the 77 th ADA session a study that was titled “Reducing A1C Levels in Individuals with High-Risk Diabetes Using the Mobile Glucose Meter Technology.” In the study we reported an average reduction in estimated HbA1C of 1.4% for high-risk type 2 Diabetes users.

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

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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 BGMS on average of 20 measurements per month during 2017.

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.

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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).

The most significant shift occurred after one month of usage (14% decrease) and maintained stability over the following months throughout the full year.

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

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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).

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.

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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 (3.1%, 7.0% and 12.2%, respectively).

In subgroup analysis focusing on users entering their meal reference, high correlation was observed following 3 months with an increase of in-range measurements in 4.6%, 8.4% and 12.0% for 0-1, 1-2 and >2 meal reference tagging per day on average, respectively, and maintained stability over 6 months period (3.2%, 7.4%, and 12.5%, respectively).

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

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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.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 months 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).

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.

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

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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 measurements was observed in a subgroup of 101 patients who started with average blood glucose levels of over 140mg/dL.

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 Advanced Technologies & Treatments for Diabetes (“ATTD”) conference in Madrid, Spain.

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

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

The 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.

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.

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

Reduction of 13% blood glucose average in age group ≥65 (N=298) at six months by 13% sustained for 12 months.

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.

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.

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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.

Post-meal readings ratio of <180 mg/dL per entire post-meal measurements increased by 5% (73.75% vs.

70.42%) on average over a year.

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

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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 on average.

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:

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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.

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

The presented data from these studies showed:

● The use of a digital diabetes platform resulted in a large population are consistent with previous studies and show the potential to promote behavior modification in users with T2D.

The study demonstrated that digital management platforms may assist user to better control their blood glucose levels and sustain behavioral change.

This observational data presented an improvement in high glycemia readings ratios, and an increase in prediabetes fasting blood glucose levels sustained over one year.

● The additional study confirmed the potential of digital diabetes solutions to sustain glycemic achievements in users with type 2 diabetes over two years.

The system may assist the users to experience an actual behavior modification in their diabetes self-management as well as in their long-term routine for self-care.

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.

Post-meal readings ratio of <180 mg/dL per entire post-meal measurements increased by 5% (73.75% vs.

70.42%) on average over a year.

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

A retrospective data evaluation study was performed on high-risk users with type 2 diabetes that measured their blood glucose using Dario ® platform database for two consecutive years.

The study assessed BGavg, estimated A1c (eA1c) values and glycemic variability following 24 months compared to the first month (baseline).

A group of 148 high-risk users with type 2 diabetes, non-Insulin treated was evaluated.

Their BGavg was of >180mg/dL (eA1c>8.0) for users taking ∼ 2 blood glucose measurements per day in the first month and in the 24 th month on average.

Their BGavg was consistently reduced by 18% and sustained (179±45 vs.

219±56 mg/dL) and eA1c was reduced by 1.5 percentage points (9.26±1.3 vs.

Glycemic variability was reduced by 20% (SD:

56) at the end of 2 years.

Additional analysis of 220 users with type 2 diabetes,147 started with eA1c >9.0% and 73 started with eA1c >10%, revealed substantial eA1c reduction of 2.0 percentage points (10.31 ± 1.8% vs.

8.36 ± 1.2%) and 2.4 percentage points (11.15 ± 1.2% vs.

8.73% ± 2.1%) from baseline after 2 years, respectively.

Glycemic variability was reduced by 20% for both (SD:

69 and 59 vs.

74, respectively).

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)

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 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 months 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.

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.

The benefit of implementing a digital diabetes interaction platform to durably improve self-management among users who had not recently measured their blood glucose.

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 by 13% 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 Feb 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.

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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.

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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 “Journal of Diabetes Science and Technology” the article:

“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 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 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 Body Mass Index (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 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