The present research is aimed at enhancing solubility and drug dissolution of clopidogrel (CPG) used as oral antiplatelet agent by employing solid dispersion (SD) technique. Total 40 SDs formulated with  drug: polymers (pluronic F127, poloxamer 407, labrafil PG, PEG 6000, gelucire 50/13), in varying ratios (1:0.5, 1:1, 1:2, 1:3, 1:4) of which CPG1 to CPG20 and CPG21 to CPG40 prepared by adopting solvent evaporation  method fusion (melt) method respectively. The formulation CPG40 containing pluronic F127 as polymer showed highest solubility of 6.57±0.04 mg/ml) that is 45 folds than pure drug. Similar results  reflected in the dissolution studies where CPG40 containing CPG: pluronic F127 in 1:4 ratio showed maximum % drug content, % practical yield and drug dissolution of 99.14% in 60 minutes when compared with other formulations and pure drug (32.76%) obtained  by fusion melt method. From FTIR studies the optimized formulation CPG40 showed the compatibility between drug and polymers. XRD and SEM studies showed CPG40 exists in amorphous form that fetched in better drug release from the SD formulation in comparison to pure drug.

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.

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.

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