Abstract 116: Unlock significant improvements in key metabolic parameters using Fitterfly diabetes program: Real world evidence from a 90-day digital therapeutics program

Background: Digital therapeutics (DTx) platforms can provide evidence-based therapeutic interventions using digital channels to promote long-term behavior change. This study evaluates the real-world data obtained from the Fitterfly Diabetes Program among people with T2DM. Methods: De-identified data of 287 participants with T2DM (Mean age: 47.38 ± 12.19 years, gender: 61.67% (177/287) female, mean duration of diabetes: 2.70 ± 5.78 years was analyzed. All participants completed 90-days on the Fitterfly Diabetes Program, which offered a combination of mobile application enabled digital logging of meals and physical activity, remote lifestyle coaching, and live video consultations by experts (psychologist, physiotherapist and nutritionist). The outcomes were analyzed at the beginning (baseline) and end of the program. Wilcoxon signed rank test was used for analysis with p < 0.05 considered as statistically significant. All data has been shown as median (IQR). Results: After completion of the program, a significant median reduction in HbA1c by -1.00 (-2.20, -0.30) % from the baseline of 7.90 (6.90, 9.50) % was observed (p < 0.0001). HbA1c levels were reduced in 86.75% (249/287) participants, among them 57.02% (142/249) participants showed HbA1c reduction of >1%. Among users who started with HbA1c above recommended level (>7%), 51.50% (103/200) reduced their HbA1c in the recommended range. A significant median reduction in body weight by -3.00 (-5.00, -1.00) kg from the baseline of 75.00 (67.00, 84.00) kg was observed (p < 0.0001 for both). Reduction in weight was observed in 82.58% (237/287) participants, among them 44.72% (106/237) showed minimum 5% weight loss. A significant median reduction in waist circumference, fasting blood glucose (FBS), and postprandial blood glucose (PPBS) by -3.00 (-7.00, -1.00) cm, -25.00 (-50.00, -10.00) mg/dL and -52.00 (-91.00, -23.00) mg/dL from a baseline of 99.00 (91.00, 108.00) cm, 138.00 (115.00, 165.00), and 190.00 (157.00, 239.00) mg/dL respectively was observed (p < 0.0001 for all). Conclusion: Significant improvement in glycemic control was observed after the completion of the program. Participants showed clinically significant reduction in waist circumference and weight. Thus, the Fitterfly Diabetes program can help in effective T2DM management by improving glycemic control and reducing T2DM-related complications. Fitterfly Diabetes Program (a digital therapeutics program) can be an effective tool as an add-on to the doctor's prescription in addressing the care gaps in T2DM management.