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

作者信息

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

机构信息

Department of Metabolic Nutrition, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India.

Department of Scientific writing and Research, Fitterfly HealthTech Pvt Ltd, Navi Mumbai, India.

出版信息

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


DOI:10.2196/43292
PMID:37133922
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10193208/
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 (HbA) 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 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 from baseline values of 8.4% (SD 1.7%), 74.45 (SD 14.96) kg, and 27.44 (SD 4.69) kg/m 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 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.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4aa7/10193208/581a3efa7c29/diabetes_v8i1e43292_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4aa7/10193208/87c21d93e399/diabetes_v8i1e43292_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4aa7/10193208/581a3efa7c29/diabetes_v8i1e43292_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4aa7/10193208/87c21d93e399/diabetes_v8i1e43292_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4aa7/10193208/581a3efa7c29/diabetes_v8i1e43292_fig2.jpg

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[1]
Fitterfly Diabetes CGM Digital Therapeutics Program for Glycemic Control and Weight Management in People With Type 2 Diabetes Mellitus: Real-world Effectiveness Evaluation.

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引用本文的文献

[1]
Adoption of Digital Therapeutics in Europe.

Ther Clin Risk Manag. 2024-12-27

[2]
Optimizing glycemic control in type 2 diabetes: the impact of the GLIDE program's personalized digital health intervention.

Front Clin Diabetes Healthc. 2024-12-3

[3]
Digital therapeutics as an emerging new therapy for diabetes mellitus: potentials and concerns.

Endocr Connect. 2024-7-1

[4]
Editorial: Computing and artificial intelligence in digital therapeutics.

Front Med (Lausanne). 2024-1-5

本文引用的文献

[1]
Personalized glycemic response led digital therapeutics program improves time in range in a period of 14 days.

Int J Diabetes Dev Ctries. 2023-6

[2]
Digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe.

Diabetol Metab Syndr. 2022-4-1

[3]
Diabetes Care in India: A Descriptive Study.

Indian J Endocrinol Metab. 2021

[4]
2022 National Standards for Diabetes Self-Management Education and Support.

Diabetes Care. 2022-2-1

[5]
IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045.

Diabetes Res Clin Pract. 2022-1

[6]
Comprehensive elaboration of glycemic variability in diabetic macrovascular and microvascular complications.

Cardiovasc Diabetol. 2021-1-7

[7]
Postprandial Glucose Spikes, an Important Contributor to Cardiovascular Disease in Diabetes?

Front Cardiovasc Med. 2020-9-18

[8]
Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial.

J Med Internet Res. 2020-8-28

[9]
The relationship between HbA1c reduction and healthcare costs among patients with type 2 diabetes: evidence from a U.S. claims database.

Curr Med Res Opin. 2020-9

[10]
Glycemic variability: adverse clinical outcomes and how to improve it?

Cardiovasc Diabetol. 2020-7-4

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