PMID- 37133922 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230520 IS - 2371-4379 (Electronic) IS - 2371-4379 (Linking) VI - 8 DP - 2023 May 3 TI - Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation. PG - e43292 LID - 10.2196/43292 [doi] LID - e43292 AB - 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/m(2) from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m(2) 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. CI - (c)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. FAU - Joshi, Shilpa AU - Joshi S AUID- ORCID: 0000-0003-3445-9357 AD - Department of Metabolic Nutrition, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India. FAU - Verma, Ritika AU - Verma R AUID- ORCID: 0000-0001-8113-8703 AD - Department of Scientific writing and Research, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India. FAU - Lathia, Tejal AU - Lathia T AUID- ORCID: 0000-0002-4481-6197 AD - Department of Endocrinology and Diabetology, Apollo Hospitals, Navi Mumbai, India. FAU - Selvan, Chitra AU - Selvan C AUID- ORCID: 0000-0001-6750-8982 AD - Department of Endocrinology and Diabetology, MS Ramaiah Memorial Hospital, Bangalore, India. FAU - Tanna, Snehal AU - Tanna S AUID- ORCID: 0000-0001-6082-8510 AD - Department of Internal Medicine, Jupiter Hospital, Thane, India. FAU - Saraf, Amit AU - Saraf A AUID- ORCID: 0000-0002-6879-9459 AD - Department of Internal Medicine, Jupiter Hospital, Thane, India. FAU - Tiwaskar, Mangesh AU - Tiwaskar M AUID- ORCID: 0000-0003-4024-0095 AD - Department of Diabetology, Shilpa Medical Research Center, Mumbai, India. FAU - Modi, Alok AU - Modi A AUID- ORCID: 0009-0003-9524-2562 AD - Department of General Medicine, Kevalya Hospital, Thane, India. FAU - Kalra, Sanjay AU - Kalra S AUID- ORCID: 0000-0003-1308-121X AD - Department of Endocrinology and Diabetology, Bharti Research Institute of Diabetes and Endocrinology, Haryana, India. FAU - K, Vasudevarao AU - K V AUID- ORCID: 0009-0001-3693-9090 AD - Department of Endocrinology and Diabetology, Hridayam Diabetes World, Thane, India. FAU - Chitale, Manoj AU - Chitale M AUID- ORCID: 0009-0007-8821-356X AD - Department of General Medicine, Shree Clinic, Nashik, India. FAU - Malde, Forum AU - Malde F AUID- ORCID: 0009-0000-3255-4620 AD - Department of Metabolic Nutrition, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India. FAU - Abdul Khader, Mohammed AU - Abdul Khader M AUID- ORCID: 0000-0002-1443-2635 AD - Department of Scientific writing and Research, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India. FAU - Singal, Arbinder Kumar AU - Singal AK AUID- ORCID: 0000-0002-7738-4327 AD - Office of Chief Executive Officer, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India. LA - eng PT - Journal Article DEP - 20230503 PL - Canada TA - JMIR Diabetes JT - JMIR diabetes JID - 101719410 PMC - PMC10193208 OTO - NOTNLM OT - application OT - continuous glucose monitoring OT - decision-making OT - diabetes OT - digital therapeutics OT - effectiveness OT - engagement OT - glucose OT - glycemic OT - glycemic control OT - mobile application OT - model OT - monitoring OT - type 2 diabetes COIS- Conflicts of Interest: AKS is the Chief Executive Officer and the cofounder of Fitterfly Healthtech Pvt Ltd. SJ, TL, and CS are consultants at Fitterfly. RV, FM, and MAK are paid employees at Fitterfly. EDAT- 2023/05/03 12:42 MHDA- 2023/05/03 12:43 PMCR- 2023/05/03 CRDT- 2023/05/03 11:54 PHST- 2022/10/07 00:00 [received] PHST- 2023/03/07 00:00 [accepted] PHST- 2023/01/31 00:00 [revised] PHST- 2023/05/03 12:43 [medline] PHST- 2023/05/03 12:42 [pubmed] PHST- 2023/05/03 11:54 [entrez] PHST- 2023/05/03 00:00 [pmc-release] AID - v8i1e43292 [pii] AID - 10.2196/43292 [doi] PST - epublish SO - JMIR Diabetes. 2023 May 3;8:e43292. doi: 10.2196/43292.