• Retrospective cohort study presented at the American Diabetes Association 83^rd Scientific Sessions analyzed real-world data of Dario users against matched controls to demonstrate a greater reduction when compared to non-users who achieve a 1.8 point reduction with the usual standard of care

NEW YORK, June 26, 2023 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, announced today the presentation of research at the American Diabetes Association 83^rd Scientific Sessions (the "Scientific Sessions") demonstrating significant reductions in HbA1c for Dario users compared to non-users. The study was conducted by Sanofi U.S. ("Sanofi") under its strategic agreement with Dario. The Scientific Sessions are being held from June 23^rd to June 26^th in San Diego, CA.

Significant Improvements in HbA1c for Dario Users with Serious Diabetes 

In an industry first, the analysis found statistically significant reductions in HbA1c compared to matched controls across real-world user data, including claims, for users and non-users of a digital health solution. Further analysis revealed that when baseline HbA1c reflected more serious diabetes the difference was even greater.

The analysis segmented study participants into four bands according to baseline HbA1c and analyzed HbA1c lab results for Dario users against a closely matched population of non-users over a period of six months. The matching process used included a unique factor: matching for motivation by selecting non-users who also had a similar HbA1c testing behavior under usual care with a physician.

The study demonstrated clinically significant differences in reductions in HbA1c for all Dario users compared to non-users, and those users with a baseline HbA1c greater than 9 points demonstrated the greatest improvement with a 2.3 point reduction in HbA1c in Dario users compared to a 1.8 point reduction for non-users.

Setting a New Standard for Digital Health Evidence Generation

This research study is the second set of end points published as a result of Dario and Sanofi's ground-breaking collaboration to set new standards in digital health research by analyzing real-world digital health data using the evidence generation standards of a pharmaceutical study. The first set of end points examined economic impact, demonstrating a 9.3% reduction in all-cause Healthcare Resource Utilization (HCRU) with a 23.5% reduction in hospitalization, was presented at ISPOR in May 2023.

The new research presented at the Scientific Sessions used HIPAA-complaint deidentified patient data linking claims, electronic medical record and laboratory results data to construct a study cohort of 568 Dario users and 1,699 matched non-users. 

"There is a growing need to bring higher quality evidence generation in digital health. We believe that Sanofi's new research ensures Dario is leapfrogging others in the space in terms of quality of evidence as well as clinical effect sizes," said Omar Manejwala, Chief Medical Officer of Dario. "With payers rightly demanding rigor in evidence for digital health solutions, this new evidence ensures that Dario is uniquely positioned to exceed these requirements."

"These data broadly demonstrate a proof-of-concept for a digital health evidence generation platform that has combined the best attributes of real-world evidence studies and traditional randomized controlled trials," said Felix Lee, Medical Head of Digital Healthcare, Sanofi. "There is tremendous potential for digital health interventions to complement usual care for people living with chronic conditions such as diabetes and we are proud to be collaborating with Dario to showcase the value of whole person care." 

This research is the first of several studies to be released based on this data analysis to demonstrate the impact of Dario on clinical, resource utilization and financial outcomes. To read more about this research, click here.

All data in the studies was collected following receipt of all required patient consents.

About DarioHealth Corp.

DarioHealth Corp. (Nasdaq: DRIO) is a leading digital health company revolutionizing how people with chronic conditions manage their health through a user-centric, multi-chronic condition digital therapeutics platform. Our platform and suite of solutions deliver personalized and dynamic interventions driven by data analytics and one-on-one coaching for diabetes, hypertension, weight management, musculoskeletal pain and behavioral health. 

Our user-centric platform offers people continuous and customized care for their health, disrupting the traditional episodic approach to healthcare. This approach empowers people to holistically adapt their lifestyles for sustainable behavior change, driving exceptional user satisfaction, retention and results and making the right thing to do the easy thing to do.

Dario provides its highly user-rated solutions globally to health plans and other payers, self-insured employers, providers of care and consumers. To learn more about Dario and its digital health solutions, or for more information, visit http://dariohealth.com.

Cautionary Note Regarding Forward-Looking Statements

This news release and the statements of representatives and partners of DarioHealth Corp. related thereto contain or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. For example, the Company is using forward-looking statements in this press release when it discusses the potential benefits realized by the use of its products, and its belief that Sanofi's new research ensures it is leapfrogging others in the space in terms of quality of evidence as well as clinical effect sizes. Without limiting the generality of the foregoing, words such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company's results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company's actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company's filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company's commercial and regulatory plans for Dario™ as described herein) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

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