A retrospective cohort study presented at the American Diabetes Association 83rd Scientific Sessions analysed real-world data of Dario users compared to matched controls. The study, conducted by Sanofi U.S. under its strategic agreement with Dario, 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, particularly for users with higher baseline HbA1c levels. The study segmented participants based on baseline HbA1c levels and found that Dario users achieved a 2.3 point reduction in HbA1c compared to a 1.8 point reduction for non-users, particularly for those with a baseline HbA1c greater than 9 points.
This research study is part of Dario and Sanofi's collaboration to set new standards in digital health research by analysing real-world data using pharmaceutical study standards. 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 findings of the study highlight the need for higher quality evidence generation in digital health and position Dario as a leader in the field. The collaboration between Dario and Sanofi aims to showcase the value of digital health interventions in complementing usual care for chronic conditions like diabetes.
Omar Manejwala, Chief Medical Officer of Dario commented, "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." "With payers rightly demanding rigour in evidence for digital health solutions, this new evidence ensures that Dario is uniquely positioned to exceed these requirements."
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