@Article{info:doi/10.2196/17908, author="Krishnakumar, Arjun and Verma, Ritika and Chawla, Rajeev and Sosale, Aravind and Saboo, Banshi and Joshi, Shilpa and Shaikh, Maaz and Shah, Abhishek and Kolwankar, Siddhesh and Mattoo, Vinod", title="Evaluating Glycemic Control in Patients of South Asian Origin With Type 2 Diabetes Using a Digital Therapeutic Platform: Analysis of Real-World Data", journal="J Med Internet Res", year="2021", month="Mar", day="25", volume="23", number="3", pages="e17908", keywords="digital therapeutics; type 2 diabetes; behavior change; diabetes self-management; lifestyle intervention; mobile phone", abstract="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. ", issn="1438-8871", doi="10.2196/17908", url="https://www.jmir.org/2021/3/e17908", url="https://doi.org/10.2196/17908", url="http://www.ncbi.nlm.nih.gov/pubmed/33764306" }