Background Digital therapeutics are evidence-based therapeutic interventions driven by high-quality software programs for the treatment, prevention, or management of a medical disorder or disease. Many studies in the western population have shown the effectiveness of mobile app–based digital therapeutics for improving glycemic control in patients with type 2 diabetes (T2D). However, few studies have assessed similar outcomes in the South Asian population. Objective This study aims to investigate the real-world effectiveness of the Wellthy CARE digital therapeutic for improving glycemic control among the South Asian population of Indian origin. Methods We analyzed deidentified data from 102 patients with T2D from India enrolled in a 16-week structured self-management program delivered using the Wellthy CARE mobile app. Patients recorded their meals, weight, physical activity, and blood sugar in the app, and they received lessons on self-care behaviors (healthy eating, being active, monitoring, medication adherence, problem solving, healthy coping, and reducing risks); feedback provided by an artificial intelligence–powered chatbot; and periodic interactions with certified diabetes educators via voice calls and chats. The primary outcome of the program was a change in glycated hemoglobin A1c (HbA1c). Secondary outcomes included the difference between preintervention and postintervention fasting blood glucose (FBG) and postprandial blood glucose (PPBG) levels; changes in BMI and weight at the completion of 16 weeks; and the association between program engagement and the changes in HbA1c, FBG, and PPBG levels. Results At the end of 16 weeks, the average change in HbA1c was –0.49% (n=102; 95% CI −0.73 to 0.25; P<.001). Of all the patients, 63.7% (65/102) had improved HbA1c levels, with a mean change of −1.16% (n=65; 95% CI −1.40 to −0.92; P<.001). The mean preintervention and postintervention FBG levels were 145 mg/dL (n=51; 95% CI 135-155) and 134 mg/dL (n=51; 95% CI 122-146; P=.02) and PPBG levels were 188 mg/dL (n=51; 95% CI 172-203) and 166 mg/dL (n=51; 95% CI 153-180; P=.03), respectively. The mean changes in BMI and weight were –0.47 kg/m2 (n=59; 95% CI −0.22 to −0.71; P<.001) and –1.32 kg (n=59; 95% CI −0.63 to −2.01; P<.001), respectively. There was a stepwise decrease in HbA1c, FBG, and PPBG levels as the program engagement increased. Patients in the highest tertile of program engagement had a significantly higher reduction in HbA1c (−0.84% vs −0.06%; P=.02), FBG (−21.4 mg/dL vs −0.18 mg/dL; P=.02), and PPBG levels (−22.03 mg/dL vs 2.35 mg/dL; P=.002) than those in the lowest tertile. Conclusions The use of the Wellthy CARE digital therapeutic for patients with T2D showed a significant reduction in the levels of HbA1c, FBG, and PPBG after 16 weeks. A higher level of participation showed improved glycemic control, suggesting the potential of the Wellthy CARE platform for better management of the disease.

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BACKGROUND Global prevalence of type 2 diabetes (T2D), especially among South Asians, has risen alarmingly in the last decade with little improvements in glucose control. OBJECTIVE We investigated the real-world effectiveness of the Wellthy CareTM (WC) digital therapeutic in improving glycemic control among the South Asian population of Indian origin. METHODS We conducted a retrospective, real-world, observational study on 102 patients with T2D from India enrolled on a 16-week structured self-management program delivered through the WC mobile app. Patients recorded their meals, weight, physical activity, and blood sugar in the app and received coaching on self-care behaviors (healthy eating, being active, monitoring, medication adherence, problem-solving, healthy coping, and reducing risks) through structured lessons, an artificial intelligence (AI)-powered chatbot, that provided real-time feedback, and periodic, planned interactions through certified diabetes educators via voice calls and chats. The Primary outcome of the program was change in HbA1c. Secondary outcomes included, difference between the pre-and post-intervention fasting blood glucose (FBG) and postprandial blood glucose (PPBG); change in BMI and weight at the completion of 16-week program; the association between program engagement, that was measured as the total number of interactions with the health coach and the AI-powered chat-bot, and the change in HbA1c, FBG, and PPBG. RESULTS At the end of 16 weeks, the average change in HbA1c was –0.49% (95% CI −0.73 to −0.25, P < .001). Out of all the patients, 63.72% had improved HbA1c levels with the mean change being −1.16% (95% CI −1.40 to −0.92, P < .001). The mean pre-and post-intervention FBG were 145.38 mg/dl (95% CI: 135.44 to 155.33) and 134.3 mg/dl (95% CI: 122.15 to 146.54, P = .023), and PPBG was 187.84 mg/dl (95% CI: 172.47 to 203.21) and 166.36 mg/dl (95% CI: 152.83 to 179.89, P = .028). Mean change in BMI and weight was –0.47 kg/m2 (95% CI −0.22 to −0.71 kg/m2, P < 0.001), and –1.32 kg (95% CI −0.63 to −2.01 kg, P < 0.001), respectively. There was a step-wise decrease in HbA1c, FBG, and PPBG as the program engagement increased. Patients in the highest tertile of program engagement had a significantly higher reduction in HbA1c (−0.84% vs −0.06%, P = .016), FBG (−21.4 mg/dl vs −0.18 mg/dl, P = .023), and PPBG (−22.03 mg/dl vs 2.35 mg/dl, P = .0022) than those in the lowest tertile. CONCLUSIONS The WC digital therapeutic intervention is associated with improved glucose control and other health outcomes. Digital interventions could potentially help in relieving the rising diabetes burden among South Asian populations by bringing about effective behavior change and better diabetes self-management.

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