Why it's notable?

The results from the study demonstrated a greater reduction in HbA1c levels for Dario users compared to non-users. The analysis showed statistically significant reductions in HbA1c across real-world user data (2.3 point reduction in HbA1c compared to a 1.8 point reduction for non-users), particularly for users with higher baseline HbA1c levels, suggesting a greater impact with increasing disease severity. These results represent an industry first for a digital health solution in management of diabetes. 

The study cohort included 568 Dario users and 1,699 matched non-users, and data was obtained from deidentified patient records, including claims, electronic medical records, and laboratory results. 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.

Industry Implications:

The multi-year collaboration between Sanofi and Dario was established to commercialise Dario’s suite of products and to set new standards of research in digital health, by analyzing real-world digital health data using the evidence generation standards of a pharmaceutical study. This is the second set of results released by Sanofi since the start of the collaboration, the first set showing the ability of Dario to reduce all-cause healthcare resource utilisation by 9.3%. In an industry where payers are increasingly demanding robust evidence from digital health companies, generation of high quality evidence through this collaboration is helping to establish Dario as a leader in the field of digital health. 

Earlier this year, Dario partnered with Dexcom to integrate its continuous glucose monitors into Dario’s platform to enable personalised interventions based on real time glucose tracking data, further enhancing the offering to users. Diabetes is a saturated space for innovation. For example, just this week, Abbot announced plans to integrate its continuous glucose monitor into the Weight Watcher’s app to enable personalized interventions based on glucose tracking; while  Dexcom also announced its collaboration  with South Korean company Kakao to set up a global digital diabetes management service, with plans to expand to the US next year. Dario’s holistic multi-condition approach stands out among other players in the diabetes field. It will be interesting to see if similar evidence is generated for emerging competitors.