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

Shilpa Joshi; Ritika Verma; Tejal Lathia; Chitra Selvan; Snehal Tanna; Amit Saraf; Mangesh Tiwaskar; Alok Modi; Sanjay Kalra; Vasudevarao K; Manoj Chitale; Forum Malde; Mohammed Abdul Khader; Arbinder Kumar Singal

doi:10.2196/43292

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

JMIR Diabetes. 2023 May 3:8:e43292. doi: 10.2196/43292.

Authors

Shilpa Joshi^#¹, Ritika Verma^#², Tejal Lathia³, Chitra Selvan⁴, Snehal Tanna⁵, Amit Saraf⁵, Mangesh Tiwaskar⁶, Alok Modi⁷, Sanjay Kalra⁸, Vasudevarao K⁹, Manoj Chitale¹⁰, Forum Malde¹, Mohammed Abdul Khader², Arbinder Kumar Singal¹¹

Affiliations

¹ Department of Metabolic Nutrition, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India.
² Department of Scientific writing and Research, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India.
³ Department of Endocrinology and Diabetology, Apollo Hospitals, Navi Mumbai, India.
⁴ Department of Endocrinology and Diabetology, MS Ramaiah Memorial Hospital, Bangalore, India.
⁵ Department of Internal Medicine, Jupiter Hospital, Thane, India.
⁶ Department of Diabetology, Shilpa Medical Research Center, Mumbai, India.
⁷ Department of General Medicine, Kevalya Hospital, Thane, India.
⁸ Department of Endocrinology and Diabetology, Bharti Research Institute of Diabetes and Endocrinology, Haryana, India.
⁹ Department of Endocrinology and Diabetology, Hridayam Diabetes World, Thane, India.
¹⁰ Department of General Medicine, Shree Clinic, Nashik, India.
¹¹ Office of Chief Executive Officer, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India.

^# Contributed equally.

PMID: 37133922
PMCID: PMC10193208
DOI: 10.2196/43292

Abstract

Background: Digital therapeutic platforms facilitate health care through patient-centered strategies based on multidisciplinary teams and shared decision-making. Such platforms can be used for developing a dynamic model of diabetes care delivery, which can help in improving glycemic control by promoting long-term behavior changes in people with diabetes.

Objective: This study aims to evaluate the real-world effectiveness of the Fitterfly Diabetes CGM digital therapeutics program for improving glycemic control in people with type 2 diabetes mellitus (T2DM) after the completion of 90 days in the program.

Methods: We analyzed deidentified data of 109 participants in the Fitterfly Diabetes CGM program. This program was delivered through the Fitterfly mobile app coupled with continuous glucose monitoring (CGM) technology. This program consists of 3 phases: the first phase is observation, wherein the patient's CGM readings are observed for 7 days (week 1); the second phase is the intervention; and the third phase aims at sustaining the lifestyle modification introduced during the second phase. The primary outcome of our study was the change in the participants' hemoglobin A_1c (HbA_1c) levels after program completion. We also evaluated the changes in participant weight and BMI after the program, changes in the CGM metrics in the initial 2 weeks of the program, and the effects of participant engagement in the program on improving their clinical outcomes.

Results: At the end of the 90 days of the program, the mean HbA_1c levels, weight, and BMI of the participants were significantly reduced by 1.2% (SD 1.6%), 2.05 (SD 2.84) kg, and 0.74 (SD 1.02) kg/m² from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m² in week 1, respectively (P<.001). The average blood glucose levels and time above range values showed a significant mean reduction by 16.44 (SD 32.05) mg/dL and 8.7% (SD 17.1%) in week 2 from week 1 baseline values of 152.90 (SD 51.63) mg/dL and 36.7% (SD 28.4%), respectively (P<.001 for both). Time in range values significantly improved by 7.1% (SD 16.7%) from a baseline value of 57.5% (SD 25%) in week 1 (P<.001). Of all the participants, 46.9% (50/109) showed HbA_1c reduction ≥1% and 38.5% (42/109) showed weight loss ≥4%. The average number of times the mobile app was opened by each participant during the program was 108.80 (SD 127.91) times.

Conclusions: Our study shows that participants in the Fitterfly Diabetes CGM program showed a significant improvement in their glycemic control and reduction in weight and BMI. They also showed a high level of engagement with the program. Weight reduction was significantly associated with higher participant engagement with the program. Thus, this digital therapeutic program can be considered as an effective tool for improving glycemic control in people with T2DM.

Keywords: application; continuous glucose monitoring; decision-making; diabetes; digital therapeutics; effectiveness; engagement; glucose; glycemic; glycemic control; mobile application; model; monitoring; type 2 diabetes.

©Shilpa Joshi, Ritika Verma, Tejal Lathia, Chitra Selvan, Snehal Tanna, Amit Saraf, Mangesh Tiwaskar, Alok Modi, Sanjay Kalra, Vasudevarao K, Manoj Chitale, Forum Malde, Mohammed Abdul Khader, Arbinder Kumar Singal. Originally published in JMIR Diabetes (https://diabetes.jmir.org), 03.05.2023.