Evaluating App-based Motivational Interviewing and AI-Powered Support for Managing Type 2 Diabetes in Primary Care A Randomized Trial

What this Trial Is About

Researchers are evaluating a new approach to managing type 2 diabetes mellitus T2DM by combining app-based motivational interviewing MI with artificial intelligence AI powered personalized nudges through a mobile application called EMPOWER-PLUS. This study is a randomized controlled trial RCT designed to improve glycemic control and reduce complications in patients with poorly controlled T2DM. The goal is to assess the effectiveness and implementation of this digital health intervention compared to usual care. The trial has three groups the intervention group receives the EMPOWER-PLUS app with AI-powered nudges, app-based MI through virtual health coaching, and a smartwatch wearable device to track physical activity and health data. The first control group receives usual care plus the smartwatch and nudges but without MI. The second control group receives usual care alone without access to the app, nudges, or smartwatch. Participants in the intervention group will be encouraged to wear the smartwatch for at least 10 hours daily to monitor steps, heart rate, sleep, and exercise. Health coaching is provided virtually via the app, videoconferencing, or phone. Participants will be monitored over 36 weeks with the primary outcome being the change in HbA1c levels, a key measure of blood sugar control. Secondary outcomes include medication adherence, diet, physical activity, quality of life, sleep quality, heart rate, healthcare costs, and app usability. The study involves regular data collection through the smartwatch and app, questionnaires, and clinical assessments. The total participation duration covers 9 months, with ongoing evaluation of both clinical and behavioral outcomes to better understand the impact of this digital diabetes management approach.

App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management