Impact of smart watch mobile application on the risk treatment of type 2 diabetes mellitus (iSMART-DM).

Abstract

Mobile health (mHealth) interventions incorporating smartwatches and personalized coaching show promise in improving diabetes self-management. Although studies report modest glycemic benefits and behavioral improvements from app-based interventions, real-world data from East Asian populations remain limited. To evaluate the effectiveness of a smartwatch-based, app-linked lifestyle intervention (iSMART-DM) in improving glycemic control and self-care behavior in patients with non-insulin-treated type 2 diabetes mellitus (T2DM). In a 12-week, open-label randomized controlled trial, 80 adults with T2DM were randomized in a 2:1 ratio to an intervention group (n = 54; smartwatch + mobile app + structured education) or a control group (n = 26; structured education alone). The primary endpoint was the change in glycated hemoglobin (HbA1c). Secondary endpoints included fasting plasma glucose (FPG), HbA1c target attainment (<6.5 %), and changes in self-care behavior scores using the Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K). Satisfaction and adherence to the digital health intervention were also assessed. After 12 weeks, the mean HbA1c change was -0.14 % and -0.13 % in the intervention and control groups, respectively (p = 0.837). No significant differences were observed in FPG change or HbA1c target attainment. However, the intervention group showed significantly greater improvement in SDSCA-K scores (+9.7 points; 95 % CI 4.0-15.6; p = 0.001), particularly in diet and physical activity. User satisfaction with the mobile platform was high, with > 85 % reporting a positive effect on daily health management. Although short-term glycemic control showed no significant difference, the smartwatch-based mobile intervention significantly enhanced self-care behaviors in patients with T2DM. These findings highlight the behavioral benefits of wearable-integrated mHealth platforms and support their broader application in lifestyle modification strategies.