Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation (Preprint)

Abstract

BACKGROUND Digital therapeutics platforms can provide patient-centered strategies based on multidisciplinary team collaborations and shared-decision making into a dynamic model of diabetes care delivery which can help in improving glycemic control by promoting long-term behavior change in people with diabetes. OBJECTIVE The study was aimed to evaluate the real-world effectiveness of the Diabefly-Pro digital therapeutics program for improving glycemic control among people with T2DM after completion of 90 days in the program. METHODS The study is based on the analysis of de-identified data of 109 participants on the Diabefly-Pro program (Fitterfly Healthtech Pvt, Ltd, India). The 90 days diabetes management program was delivered through a Fitterfly mobile application coupled with CGM technology. The participants undergo three phases during the program; the observation phase is the first phase which involves 7 days (week-1) of CGM monitoring; the second and third phase of the program involves participants following a personalized lifestyle plan. The primary outcome of the study was the change in HbA1c level pre and post the program. The study also evaluates the change in weight, BMI post the program, changes in CGM metrics in the initial 2 weeks of the program and role of program participation in the outcomes. RESULTS At the end of the 90 days, mean HbA1c, weight, and BMI was significantly reduced by 1.21 ± 1.63 %, 2.05 ± 2.84 kg, and 0.74 ± 1.02 kg/m2 from a baseline value of 8.39 ± 1.67 %, 74.45± 14.96 kg, and 27.44 ± 4.69 kg/m2 in week 1 respectively (P < .0001 for all). The average blood glucose, and time-above-range showed a significant mean reduction by 16.44 ± 32.05 mg/dl, and 8.66 ± 17.08 % in week 2 from a week-1 baseline value of 152.90 ± 51.63 mg/dl, and 36.74 ± 28.35 % respectively (P < .0001 for both). Time-in-range significantly improved by 7.12 ± 16.73 % from a baseline value of 57.48± 25.03 % in week 1 (P<0.0001). Among all the participants, 46.87 % (50/109) showed HbA1c reduction ≥ 1% and 38.53 % (42/109) of participants showed weight loss of ≥ 4% respectively. The average number of times the mobile application was opened per user during the program was 108.80 ± 127.91. CONCLUSIONS At the end of the program, the study participants with T2DM showed a significant improvement in their glycemic control and weight loss. During these 90 days, high level of engagement with the platform was observed. This study demonstrated significant association between the level of HbA1c reduction and weight reduction with the program participation metrics. Thus, Diabefly-Pro digital therapeutics program can be an effective tool to improve glycemic control among people with T2D.