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

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 A1c (HbA1c) 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 HbA1c 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 HbA1c 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.

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

Background: Lifestyle modification is an integral aspect for the management of type 2 diabetes (T2D). However, it is difficult to ensure the accuracy of personalized lifestyle advice. The study aims to analyse the real-world effectiveness of personalized glycemic response based Diabefly-Pro digital therapeutics for better glycemic control. Methods: Data from continuous glucose monitoring (CGM) of 64 participants with T2D was analysed. All participants were provided with modified lifestyle plan based on their personalized glycemic response. The CGM data was analysed for a period of 7 days, before and after the introduction of modified lifestyle plan. Primary outcome of the study was change in time in range (TIR). Secondary outcomes of the study were change in mean blood glucose, time above range (TAR), time below range (TBR) and glucose management indicator (GMI). Results: Significant improvement in glycemic control was observed after the introduction of personalized lifestyle plan. Median reduction in mean blood glucose was from 139.5 (118.3 to 169.3) mg/dL to 122.0 (101.5 to 148.8) mg/dL (p < 0.0001). TIR and GMI improved from 70.50 (50.75 to 83.50) % to 75.00 (58.25 to 89.00) % (p = 0.0001) and 6.64 (6.13 to 7.35) % to 6.23 (5.74 to 6.86) % (p < 0.0001) respectively. TAR reduced significantly from 17.00 (4.25 to 38.0) % to 6.00 (1.25 to 26.0) % (p < 0.0001). No significant increase in TBR was observed (p = 0.198). Conclusion: Personalized glycemic response-based Diabefly-Pro digital therapeutics program was effective in achieving better glycemic control in people with T2D.

Video Call-based Fitness Assessment shows Poor Fitness in People with Type II Diabetes: Findings from Diabefly Digital Therapeutics Program.

OBJECTIVE: Exercise and physical activity are integral aspects for the effective management of diabetes. Unsupervised home exercise although very accessible is limited by poor adherence, risk of injury, and a higher dropout rate of participants. A fitness assessment by a qualified physiotherapist can help in understanding the baseline fitness of individuals and thus generating appropriate exercise prescriptions. The current study assesses the feasibility of video call-based fitness assessment for people with diabetes. The study also assesses the effect of current physical activity status and pain on performance in physical fitness tests. METHODS: One hundred participants with type II diabetes (T2D) underwent 6-minute walk test (6MWT), 1-minute push-up test, wall sit test, 1-minute sit-up test, and V-sit and reach test for measuring different components of physical fitness such as aerobic capacity, upper body strength, lower body strength, core strength, and flexibility, respectively. The performance in physical fitness of participants was analyzed after the video consult along with pain complaints and current exercise status. RESULTS: All the participants underwent the physical fitness test safely based on video call. Out of all the participants, a good range score was achieved by 52% in 6MWT, 17% in push-up test, 1% in wall sit test, 6% in sit-up test, and 9% in V-sit and reach test. Current physical activity status (aerobic exercise for minimum 20 minutes) did not show any association with performance in fitness tests (p = 0.89 for push-up test, p = 0.50 for wall sit test, p = 0.23 for sit-up test, and p = 0.10 for V-sit and reach test). Presence of upper body and lower body pain affected the performance in push-up test and wall sit test with 71.4% and 95.6% of participants achieving scores in poor to below-average range (p-value < 0.001). CONCLUSION: The study showed the safety and feasibility of conducting video call-based assessment of physical fitness by physiotherapists. The study also highlighted the poor glycemic control, high cardiovascular risk, and poor level of physical fitness in people with diabetes in India. Insights based on physical fitness, current physical activity status, and pain can help in developing personalized exercise plans for people with diabetes.

Consensus on Insulin Dose and Titration Algorithms in Ambulatory Care of Type 2 Diabetes in India.

INSTRUCTION: Insulin is the oldest of the currently available treatment options in Type 2 diabetes mellitus (T2DM) and is considered as the most effective glucose lowering agent. Despite this, decision on starting insulin therapy is often delayed in India as well as worldwide due to various barriers at both patient and physician levels. Appropriate insulin dosing and titration is also critical to the successful achievement of tight glycaemic control. OBJECTIVE: To provide simple and easily implementable guidelines to primary care physicians on appropriate insulin dosing and titration of various insulin regimens for both initiation and intensification. METHODOLOGY: Each insulin regimen (once daily [OD] basal, OD, twice daily and thrice daily premixed, basal-plus and basal-bolus) was presented and evaluated for dosing and titration based on established guidelines, data from approved pack inserts, and published scientific literature. These evaluations were then factored into the national context based on the expert committee representatives patient-physician experience in their clinical practice and common therapeutic practices followed in India. RESULTS: Recommendations for dosing and titration of basal, basal-plus, premixed and basal-bolus insulins were developed. The key recommendations are that insulin doses can be adjusted once or twice weekly; adjustment can be based on lowest/mean of three recent self-monitoring of plasma glucose pre-meal/fasting plasma glucose (FPG) values. The titration should be based on FPG or pre-meal value of 80-130 mg/dL and the dose should be reduced by 10-20% for patients reporting hypoglycaemia(<70mg/dL). CONCLUSIONS: The consensus based recommendations mentioned in this paper will be a useful reference tool for health care practitioners, to initiate, optimise and intensify insulin therapy and to successfully achieve optimal glucose control.