Score another win for digital therapeutics. We’ve written about FDA approval for prescribed digital therapeutics, a Consumer Technology Association (CTA) initiative to develop a set of standards for digital therapeutics, and the pandemic’s influence in speeding new digital therapeutics adoption.
San Francisco-based Omada Health presented a paper at ObesityWeek Interactive last week that demonstrated that Omada’s PREDICTS digital therapeutics trial achieved a significant improvement in body weight loss and blood glucose (HbA1c) levels during a 12-month study. The PREDICTS (Preventing Diabetes with Digital Health and Coaching for Translation and Scalability) trial results indicate “clinically meaningful improvement” in people with prediabetes.
The trial involved 599 people with prediabetes. The individuals were randomly assigned to attend a single-session diabetes prevention class or to participate in Omada’s Diabetes Prevention Program (d-DPP). The d-DPP included weekly sessions, lifestyle coaching, virtual peer support, and behavior tracking tools. The two groups had their Hemoglobin A1c and body weight measured at the start and the end of the 12-months.
The study results showed statistically significant greater positive results in HbA1c levels and body weight. The d-DPP participants had an average 5.4% weight loss and 0.23% reduction in blood glucose at the end of 12 months, compared to 2% weight loss and 0.15% in HbA1c levels for the control group.
Omada includes other result metrics in the news release, but overall the d-Dpp participants fared better than the base group in all measures. One slight fly in the ointment is the Omada program includes multiple components. Future testing to isolate the effectiveness of the various factors such as lifestyle coaching or virtual peer support would be extremely useful.
