10-K
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tm211148d1_10k.htm
FORM 10-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
For the fiscal year ended December 31,
2020
For the transition period fromto
Commission File No. 001-37704
DARIOHEALTH CORP.
(Exact name of registrant as specified in
its charter)
(Address of principal executive offices) (Zip Code)
(646) 665-4667
(Registrant’s telephone number, including
area code)
Securities Registered pursuant to Section 12(b) of
the Act
Title of each class Trading Symbol(s) Name of each exchange on which registered:
Common Stock, par value $0.0001 per share DRIO The Nasdaq Stock Market LLC
Warrants to purchase Common Stock DRIOW The Nasdaq Stock Market LLC
Securities registered pursuant to Section 12(b) of
the Exchange Act: None
Securities registered pursuant to Section 12(g) of
the Act: Common Stock, par value $0.0001 per share; Warrants to purchase Common Stock
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ̈No x
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ̈ No x
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ̈
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period
that the registrant was required to submit such files). Yes x
No ̈
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ̈ Accelerated filer ̈
Non-accelerated filer x Smaller reporting company x
Emerging growth company ̈
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
̈
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by
the registered public accounting firm that prepared or issued its audit report. ̈
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ̈ No x
The aggregate market value of the voting
and non-voting common equity held by non-affiliates computed by reference to the closing price as of the last business day of the
registrant’s most recently completed second fiscal quarter is $26,029,228.
As of March 5, 2021, the registrant had
outstanding 15,273,389 shares of common stock, $0.0001 par value per share.
Documents Incorporated By Reference: None.
TABLE OF CONTENTS
Item No. Description Page
Cautionary Note Regarding Forward-Looking Statements 1
PART I
Item 1. Business 3
Item 1A. Risk Factors 21
Item 1B. Unresolved Staff Comments 44
Item 2. Properties 44
Item 3. Legal Proceedings 44
Item 4. Mine Safety Disclosures 44
PART II
Item 6. Selected Financial Data 48
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 57
Item 8. Financial Statements and Supplementary Data 57
Item 9A. Controls and Procedures 58
Item 9B. Other Information 59
PART III
Item 10. Directors, Executive Officers and Corporate Governance 60
Item 11. Executive Compensation 65
Item 14. Principal Accounting Fees and Services 80
PART IV
Item 15. Exhibits and Financial Statement Schedules 81
Signatures 84
CAUTIONARY NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This Annual Report
on Form 10-K, or the Annual Report, contains “forward-looking statements,” which includes information relating
to future events, future financial performance, financial projections, strategies, expectations, competitive environment and regulation.
Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,”
“continue,” “expects,” “anticipates,” “future,” “intends,” “plans,”
“believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking
statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate
indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when
those statements are made or management’s good faith belief as of that time with respect to future events, and are subject
to significant risks and uncertainties that could cause actual performance or results to differ materially from those expressed
in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited
to:
● our launch and market penetration plans;
● the expected execution of agreements with various providers for our solution;
● our ability to develop, launch and commercialize the Dario Loop;
● our ability to maintain our relationships with key partners;
● our ability to retain key executive members;
● our ability to internally develop new inventions and intellectual property;
● interpretations of current laws and the passages of future laws; and
● acceptance of our business model by investors.
The foregoing does
not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors
that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. Please
see “Risk Factors” for additional risks that could adversely impact our business and financial performance.
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Moreover, new risks
regularly emerge and it is not possible for our management to predict or articulate all the risks we face, nor can we assess the
impact of all risks on our business or the extent to which any risk, or combination of risks, may cause actual results to differ
from those contained in any forward-looking statements. All forward-looking statements included in this Annual Report are based
on information available to us on the date of this Annual Report. Except to the extent required by applicable laws or rules, we
undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future
events or otherwise. All subsequent written and oral forward-looking statements attributable to us or persons acting on our behalf
are expressly qualified in their entirety by the cautionary statements contained above and throughout this Annual Report.
When used in this Annual
Report, the terms “DarioHealth,” “the Company,” “we,” “our,” and “us”
refer to DarioHealth Corp., a Delaware corporation and our subsidiary LabStyle Innovation Ltd., an Israeli company. “Dario”
is registered as a trademark in the United States, Israel, China, Canada, Hong Kong, South Africa, Japan, Costa Rica, and
Panama. “DarioHealth” is registered as a trademark in the United States and Israel.
All information in
this Annual Report relating to shares or price per share reflects the 1-for-20 reverse stock split effected by us on November 18,
2019.
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PART I
Item 1. Business
Overview
We are a leading global
Digital Therapeutics (“DTx”) company revolutionizing the way people manage their health across the chronic condition
spectrum to live a better and healthier life. Our mission is to transform how affected individuals manage their health and chronic
conditions by empowering our customers to easily manage their conditions and take steps to improve their overall health. Most chronic
conditions are driven by personal behaviors and the individual actions that are or are not taken. We believe that changing these
behaviors can dramatically improve our customers’ overall health and substantially reduce unnecessary health spending. However,
behavioral change and habit formation are difficult, especially in managing chronic disease and related conditions. Our digital
therapeutics endeavor to produce lasting behavior changes in our customers by applying a novel combination of artificial intelligence
(“AI”)-driven dynamic personalization and behavioral science at scale. This allows us to engage and support our customers,
and offer them a complete virtual care solution, ideally resulting in improved health outcomes and reduced total cost of care.
Our
principal operating subsidiary, LabStyle Innovation Ltd., is an Israeli company with its headquarters in
Caesarea, Israel. We were formed on August 11, 2011, as a Delaware corporation with the name LabStyle Innovations
Corp. On July 28, 2016, we changed our name to DarioHealth Corp. We began our sales in the direct-to-consumer space,
solving first for what we deemed the most difficult problems: how to engage users and support behavior change to improve
clinical outcomes in diabetes. Our most developed AI tools leverage the direct-to-consumer experience from over 150,000
members to drive superior engagement and outcomes. In early 2020, we broadened our solutions to include other medical
conditions in addition to diabetes, and to serve business customers who seek to improve the health of their stakeholders.
Presently, we have deployed solutions for diabetes, hypertension, and pre-diabetes, and through our acquisition of Upright
Technologies Ltd. (“Upright”), we now offer solutions for musculoskeletal (“MSK”) conditions. We are currently
delivering B2B2C solutions for providers, employers, and pharmaceutical companies, and we plan to develop a full-risk health
plan business, which we expect will provide our AI driven, remote patient monitoring (“RPM”) and coaching
for a variety of chronic conditions, across a range of customer product lines in 2021.
Upright Technologies
Ltd., which we acquired in February 2021, is a leading digital MSK health company focused on preventing and treating the most
common MSK conditions through behavioral science, biofeedback, coaching, and wearable tech. Upright has over 90,000 active users
and its clinically validated solution is recommended by more than 500 clinics worldwide.
In-market first-generation
digital health solutions offer static or nominal personalization at best, integrating signals to customize nudges or personalize
communications in a manner that does not significantly adapt to changing user needs over time, while user journey’s, or experiences,
remain fairly static. First generation solutions generally lack user experience benefit of insight from tens of thousands of direct-to-consumer
engagements over years that adaptively personalize user journeys for high engagement and outcomes. These solutions are often described
as “fingerprinted,” but while fingerprints don’t change over time, users do. As a result, any static or minimally
dynamic approaches are not sufficiently customized to address user needs.
Market intelligence
confirms that enterprise customers are frustrated by existing solutions with static user journeys, limited transparency, inability
to integrate with existing technologies and workflows, low engagement and retention and challenges with flexible deployments. Some
customers want a single solution for most-major chronic conditions, others wish to deploy piecemeal solutions or may have already
invested in solutions for a portion of their populations. Health systems and health plans have invested significantly in their
technology and digital strategy and require solutions that interoperate with their existing and planned deployments. First generation
digital health solutions that have piloted with complex customers such as health plans have been forced to pivot their business
strategies to employers and others owing to enrollment, integration, return on investment and reporting challenges. Our solutions
are designed from the ground-up for integration, can be deployed for single or multiple conditions, deliver behavioral-science
informed dynamically personalized and integrated user journeys, deliver clear returns on investment in required time horizons and
allow for real-time granulated customer reporting.
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Unlike other digital
health solutions, we also personalize user experience beyond nudges. Healthcare journeys and pathways must be individualized, informed
by behavioral science, and dynamically responsive to drive engagement and outcomes. Customized, dynamic user journeys are delivered
by our AI-driven journey engine, the “Dario Loop” (formerly called Dario Intelligence), which personalizes user experience
across a range of factors including timing, tone, channel, content, frequency, and intervention. We believe that our dynamic personalized
approach ensures superior engagement and retention, reduced costs, and ultimately, improved user health. This is reflected in our
user experience feedback, with an unparalleled 4.9 out of 5 stars across more than 15 thousand reviews in the Apple App Store,
a best-in-class net promoter score of 76, and industry-leading, published improvements in clinical metrics such as estimated glucose
monitoring (“HbA1c”), hypertension (“HTN”), pain and health-related quality of life.
Our Solutions
We offer a customized,
user-centric, modular platform integrating digital therapeutics, coaching, devices, and care providers. Our suite of offerings
includes Dario Tools, which are devices that integrate with applications on a user’s smartphone, DarioEngage, a population
health management platform (“DarioEngage”), and the Dario Loop, our AI-driven journey engine.
Dario Tools
Our platform is designed
for integration across a range of devices including partner devices. Our digital architecture and user experience can easily integrate
with partnered devices such as continuous glucose monitor (“CGM”) and other remote patient monitoring devices. For
example, we recently partnered with one of the “big 4” diabetes companies to integrate their meter as well in certain
commercial deployments. Our native devices include:
• All-in-one smart glucose meter
• Bluetooth connected blood pressure cuff
• Digital Scale
• Upright MSK training device
Because of the widespread
and growing use of smartphones and the evolution of user preferences, our primary device is the user’s smartphone. Our connected
device strategy has been to develop or acquire devices when existing market requirements are not adequately met (for example, our
smart glucometer and Upright’s MSK device), and to partner with best-in-class devices for the remaining applications (including,
for example, our digital scale, blood pressure cuff, and CGM).
DarioEngage
Dario targets conditions
for which behaviors drive a significant portion of the outcomes, and which conditions bear a substantial cost burden to our users.
We combine our “Dario Tools” with our software, by which we offer RPM of their conditions and progress. Dario divides
its solutions into metabolic and non-metabolic categories:
• Non-Metabolic conditions currently deployed include MSK conditions.
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We present our users
with a digital center of excellence - a low friction 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 that simplifies
deployments, creates market-leading transparency, and accelerates and broadens user engagement.
The Dario Loop
Users vary significantly
in their interests and preferences, and unique user preferences also vary over time, insofar as optimal timing, tone, content,
channel, frequency, and intervention required to produce sustained behavior change. Users interactions with devices, smartphones,
coaches, providers, and third-party solutions must be personalized along these axes to ensure optimal engagement, retention, and
outcomes. To engage and sustain user interest and participation, and to drive outcomes, platforms must be dynamically responsive.
Because of a lack of responsiveness to these types of variances, many digital health platforms that achieve high initial engagement
often fail to retain users over time.
Key to our ability
to accommodate user behavioral changes is our mature AI-driven user journey engine, the “Dario Loop.” 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 150,000 users, enabling us to continually
personalize and adapt user journeys over time. The Dario Loop 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.
The Dario Loop combines
complex behavioral science insights with data from tens of thousands of users over several years to recommend AI-driven initial
and updated care journeys in response to a user’s engagement with the platform. Most digital health solutions consist primarily
of tracking, content, and nudges. These are often perceived by users as non-rewarding work, and often do not feel relevant to their
concerns, particularly as they evolve over time. We believe that current in-market solutions trivialize within person changes over
time and do not appropriately respond to dynamically evolving interests of users. This results in reduced engagement and impaired
outcomes. The Dario Loop adapts user journeys’ to drive engagement, retention, and clinical outcomes by optimizing timing,
tone, channel, content, frequency and intervention to deliver dynamically personalized user journeys that are more likely to result
in the behavior changes needed to drive improved outcomes across a range of conditions. As we partner with solutions in additional
conditions or categories, we “loop them in” to our solution, enhancing the engagement and efficacy of these partnered
solutions to deliver additional value to our users. The engine is designed for integration and scale; as we add populations and
conditions for which behaviors are primary drivers of outcomes, our engine becomes more adept at customizing a user’s preferences
and needs.
Our Growth Strategies
Add
customers across a range of channels. Due to our unique ability to deploy flexibly and interoperability, and since we
cover the range of chronic conditions of common concern to health plans, providers and employers, we are experiencing increased
interest in our behavior change platform for chronic diseases. We have already engaged with several large providers and one fortune
500 company subsidiary, and are in late stage negotiations to enter contracts with several health plans on their fully insured
businesses. We anticipate continued growth and demand in these channels as we acquire customers. 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.
Increase
the eligible populations within customers. Initially, Dario’s solutions were deployed for type I and type II diabetes.
Since that time, we have added HTN, MSK. Each new condition added 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.
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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. A user is considered as an engaged user if (i) the user is measuring high
blood glucose and/or blood pressure using our app and our connected devices, (ii) a user is interacting with our coach via
one of the communication channels such as chat, SMS, email or phone call, or (iii) a user who is performing one of the following
activities on his application such as: reading messages of articles sent to him over the app, setting or updating goal on his application,
updating his profile, tagging meals, recording intake of drugs and other activities available on our application.
Optimize
solutions for value. Our customers primarily engage for 3 key reasons: (1) the opportunity for cost savings; (2) our
competitive advantage in breadth of conditions serviced and our AI technology; and (3) revenue opportunities from our digital
center of excellence. 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.
Acquisitions
and Partnerships. In early 2021, as part of our plan to expand our suite of offerings to provide a wider range of solutions
to our potential customers, we acquired Upright, and we are now planning to deploy a comprehensive MSK virtual
clinic in the second half of 2021.
Post-COVID
Rebalancing: The COVID-19 pandemic has had a major impact on health. Our members and eligible members were disproportionately
affected as researched showed that chronic condition comorbidities increased the risk of hospitalization and death from COVID-19.
In 2020, telehealth and digital care spiked significantly, as health plans and providers sought to deliver solutions virtually.
Across the industry, telehealth use spiked in 2020 and has since withdrawn some, albeit to still more than 50x pre-pandemic levels.
However, telehealth as delivered today is not appreciably different from how it was delivered 30 years ago, with largely telephone
only visits, and even where video is present, remote monitoring, real-time data and device integration remain mostly absent. Our
customers and potential customers recognize the tremendous potential of building on the shift to telehealth with the evolution
of more complete virtual care models as they see the limitations of pure telehealth-based care for chronic conditions.
Sales and Marketing
Our initial marketing
efforts in the United States were focused on the early adopter users who have diabetes and who are paying out of pocket for their
monitoring tools to manage their chronic condition, and we have concentrated our efforts in gaining market share and brand awareness
through direct-to-consumer marketing efforts.
In 2018, we began to
expand our marketing efforts to the insured population by offering our DarioEngage platform to a variety of healthcare providers
who are supporting and coaching individuals with diabetes. We believe this will help us to diversify our revenues, from only selling
our Dario Blood Glucose Monitoring System and its consumables to revenues generated from providing online real-time monitoring,
supervising and coaching capabilities to all relevant healthcare providers who support individuals with diabetes and hypertension,
and in the longer terms also other chronic conditions. As part of these efforts, during 2019 we announced our planned cooperation
with Attain Health, Giant Eagle, BestBuy, and Better Living Now (BLN).
On the marketing side,
we primarily utilize online marketing in order to create awareness of Dario. Rather than solely rely on an online advertisement,
we will also consider revenue sharing with affiliate networks and a variety of other pay-for-performance methods commonly used
in online commerce.
We also expect to collaborate
with the medical community to showcase what we expect will be the Dario Smart Diabetes Management Solution’s clinical equivalence
and usability superiority through DarioEngage and Dario Loop.
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As part of transforming
our offering from the direct-to-consumer market to the (B2B2C and payors market, in the beginning of 2020, we hired a President
and General Manager for North America who is leading our sales and marketing organization in the United States aimed to offer
our digital solution to health plans, employers, hospital, clinics, and remote patient monitoring centers. We expect this organization
to grow as we enter into service agreements with such payors. In that regard, in 2020, we announced a variety of agreements expanding
our sales in the B2B2C market including: (i) in January 2021, our announcement that we entered into an agreement to
provide its digital therapeutics solution to eligible employees of a subsidiary of a U.S. based Fortune 500 technology and engineering
company, which was obtained through our partnership with the Vitality Group (“Vitality”); (ii) in December 2020,
we announced that we entered into an agreement to provide our RPM solution to Presbyterian
Medical Services, one of the largest integrated healthcare systems in the State of New Mexico, effective January 1,
2021; (iii) in November 2020, we announced that we entered into an agreement to provide our digital therapeutics solution
to eligible employees of a U.S.-based Fortune 500 technology company; (iv) in October 2020, we announced our
inclusion in Vitality’s Gateway Flex offering, allowing our digital therapeutics platform to be marketed to Vitality's vast
employer base that provides benefits solutions to 20 million people, (v) in September 2020, we announced our partnership
with HMC Healthworks, that extends our reach into HMC's vast multi-employer client base through which HMC is currently managing
more than one million members; (vi) in July 2020, we announced that we entered the U.K. RPM market through an agreement
with Williams Medical, making our platform available to healthcare professionals throughout the U.K. and Ireland; and (vii) in
June 2020, we announced two RPM agreements in the U.S., allowing healthcare providers to monitor patients between office
visits while utilizing new CMS reimbursement codes, an added source of revenue.
Manufacturing
As we do not directly
manufacture our products ourselves, we have supply agreements with manufacturers for the Dario Blood Glucose Monitoring System,
glucose test strips, lancing devices, lancets, blood pressure monitor and weight scale. We have arrangements in place
with commercial-scale manufacturers for both the Dario Blood Glucose Monitoring System, for our test strips and the other
devices. As a result of investments, we have made over the past several years, we own the specialized equipment used to manufacture Dario
Blood Glucose Monitoring System.
During 2015, we commenced
the manufacturing of our Dario Blood Glucose Monitoring System with a Chinese manufacturer as part of our efforts to further reduce
manufacturing cost. At the beginning of 2016, we transitioned our manufacturing to a new Chinese manufacturer as part of our effort
to increase our manufacturing capacity and improve cost savings.
Our primary
product offering is primarily subscription based software and services which do not require manufacturing, and which are
developed by us.
Clinical Studies and Outcomes
Our platform is planned
to target different chronic conditions. Our initial focus has been on diabetes because that is a condition in which we believe
there is the biggest opportunity to make a meaningful impact and improve healthcare outcomes and lower costs. It is also a condition
that is associated with multiple different comorbidities, each of which represents a significant health and economic burden. The
majority of our end-users are individuals with type 2 diabetes. Most people with type 2 diabetes are diagnosed after age 45 and
have at least two co-existing chronic conditions. The most common chronic condition in people living with type 2 diabetes include
hypertension (73.6%), overweight/obesity (87.5%), hyperlipidemia (75.2%), chronic kidney disease (36.5%), and cardiovascular disease
(32.2%). Typically, the health of people with type 2 diabetes is managed by a primary care physician, although few may also be
seen by an endocrinologist.
On average, people
with type 2 diabetes see a physician more than five times per year. While there are a number of metrics that physicians use to
track the health of these patients, the most common is hemoglobin A1c, or HbA1c, which measures the average 90-day glycemic (blood
glucose) level in red blood cells. Clinical guidelines published by the ADA suggest that a reasonable HbA1c target for many non-pregnant
adults is less than 7%, or 154 milligrams per deciliter. A higher HbA1c has been associated with increased health risk and associated
costs. The ADA estimates that annual healthcare costs for a person with diabetes cost an average of $16,750 compared to $7,151
for a healthy individual. Research published by Oxford University in the United Kingdom suggests that a 1% reduction in HbA1c levels
leads to a 21% reduction in death from diabetes, a 14% reduction in heart attacks and a 43% reduction in peripheral vascular disease.
Monitoring HbA1c levels is typically done through routine blood work in a clinical laboratory with a physician order. Treatment
can involve a range of therapies, the most common of which is lifestyle management such as nutrition, physical activity and medication.
Physicians will also employ various strategies to manage diabetes-associated comorbidities.
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We believe that patients
using a digital diabetes management platform have the potential to promote behavioral modification and sustain adherence to diabetes
management, demonstrating better glycemic control. Our sophisticated customer-focused solutions provide significant, meaningful
improvements in the measurable clinical outcomes of our members.
Clinical Studies
The system accuracy and user performance
of our product has been evaluated in several studies that we have performed, in over 1,300 diabetic patients from 2015 through
2017, and was found compliant with the most stringent current requirements of FDA guidelines and international standards then in
effect.
Clinical validation
of our product was performed with 350 diabetic patients for each product type, namely the meter with the audio jack and the meter
with the lightning connector, and the results that were achieved were as follows:
Published Clinical Data
Since 2017, we have
conducted numerous real-world-data studies through analyzing the clinical data of our user’s utilizing the rapidly increasing
database that is stored on our data cloud.
Several scientific
studies were published by us between 2017 and through 2020 in leading diabetes conferences such as the ADA, AADE and ATTD.
Main Highlights
In all of the below
studies, we believe that the results show a trend of continued improvement, demonstrating a direct correlation between using the
Dario Blood Glucose Monitoring System and app and improving clinical parameters. The combination of Dario’s Blood Glucose
Monitoring System and app may promote behavioral modification and enhanced adherence to diabetes management, demonstrating improvement
in glycemic outcomes and sustainment for a long period of time.
Dario reported
an Average Reduction in Estimated HbA1C of 1.4% for High-Risk type 2 Diabetes Users.
Dario presented at
the 77th 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.
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
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Method:
A retrospective data evaluation study was performed on the DarioTM cloud database. A population of all active Type 2
Diabetic (T2D) users that took measurements with DarioTM 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.
Results:
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). 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
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 58% of Hyper events (>400mg/dL) in T2D within 12 months
Method:
A retrospective data evaluation study was performed on the DarioTM cloud database. A population of active Type 2 Diabetic
(T2D) users that continuously measured their blood glucose using DarioTM 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.
Results:
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 12th 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
· Reduction of 14% Blood Glucose average was observed in T2D within 12 months
Methods:
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 of 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.
Results:
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. baseline. 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.
9
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.
Method:
A retrospective data evaluation study was performed on the DarioTM cloud database. A population of high-risk (with baseline
A1C > 7.5 percent), active users that continuously measured their blood glucose using DarioTM 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.
Results:
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 12th 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 on 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
· Hypo events (<70 mg/dL) remained <1 event on average
Method:
A retrospective data evaluation study was performed on the DarioTM database. A population of T2D high-risk
patients (blood glucose measurements average (GMavg) >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 GMavg
were calculated and compared to the baseline.
Results:
A group of 698 T2D high-risk DarioTM 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). GMavg 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
Method:
A retrospective data evaluation study was performed on the DarioTM cloud database. A population of active Type 2 Diabetic
(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.
10
Results:
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
30-40% of T2D Dario
users experienced Reduction of Blood Glucose Average below 140 mg/dL
Method:
A retrospective data evaluation study was performed on the DarioTM 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.
Results:
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).
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 measurements was observed in a subgroup of 101 patients
who started with average blood glucose levels of over 140mg/dL.
In February 2020,
we presented an additional clinical study at the Advanced Technologies & Treatments for Diabetes (“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
Method:
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 year 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).
Results:
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 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. The system assists users
through a variety of mechanisms including behavior modification in diabetes self-management and in long-term routines for self-care.
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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.
Method:
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).
Results:
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. 56)
. 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%
In August 2020, we
presented an additional clinical study at the Virtual Association of Diabetes Care & 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.
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 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.
Methods:
A retrospective data evaluation study was performed on the DarioTM 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, average blood glucose (BGavg) and high blood glucose readings (>250
mg/dL, >400 mg/dL) ratios.
Results:
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:
· Blood Glucose:
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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:
Users with type 2 diabetes using a digital platform experienced
sustained improvement in blood glucose levels.
Method:
A retrospective data evaluation (Q1:2018-2019) was performed on the Dario® data base. A population of active