Using an app for motivational interviewing and AI to manage diabetes
EMPOWERing Patients with Type 2 Diabetes Mellitus (T2DM) in Primary Care Through App-based Motivational Interviewing PLUS Artificial Intelligence Powered Diabetes Management (EMPOWER-PLUS): Randomised Controlled Trial
This study is testing if using an app that combines motivational support and personalized reminders can help people with Type 2 Diabetes manage their condition better over 36 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 525 (estimated) |
| Ages | 21 Years to 100 Years |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 3 sites (Singapore and 2 other locations) |
| Trial ID | NCT06214520 on ClinicalTrials.gov |
What this trial studies
This project aims to improve diabetes management for individuals with Type 2 Diabetes Mellitus (T2DM) by combining app-based motivational interviewing with AI-powered personalized nudges delivered through a mobile application called Empower+. The study will evaluate the effectiveness of this approach through a randomized controlled trial (RCT) with three arms, focusing on the primary outcome of HbA1c levels at week 36. Secondary outcomes will assess cost-effectiveness, quality of life, medication adherence, diet, and physical activity. Participants will be required to use a smartwatch tracker and the Empower+ app to monitor their progress.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and above diagnosed with Type 2 Diabetes Mellitus and with an HbA1c level of 7.5% or higher.
Not a fit: Patients on bolus insulin treatment or those requiring assistance with daily living activities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better glycemic control and improved overall management of Type 2 Diabetes Mellitus.
How similar studies have performed: While motivational interviewing has shown promise in diabetes management, this specific app-based approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 21 years and above * Have been diagnosed with diabetes (T2DM) * Had HbA1c result of ≥ 7.5% within past 3 months * Physically able to exercise * Able to read and converse in English * Able to download the Empower+ app, use the smartphone wearable tracker, and conform to the minimum smartwatch and app monitoring schedule Exclusion Criteria: * On bolus insulin treatment * Require assistance with basic activities of daily living (BADL) * Have planned major operation or surgical procedure within 9 months from the time of recruitment * Cognitively impaired (scored \< 6 on the Abbreviated Mental Test) * Currently pregnant or lactating * Current participants of ongoing clinical trials involving the usage of a smartphone wearable tracker or mobile health app to assist diabetes management * Past Empower study participants who refused to participate in future Empower studies
Where this trial is running
Singapore and 2 other locations
- SingHealth Polyclinic (Punggol) — Singapore, Singapore (Recruiting)
- SingHealth Polyclinic (Sengkang) — Singapore, Singapore (Recruiting)
- SingHealth Polyclinic (Tampines) — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Lian Leng Low — Singhealth Foundation
- Study coordinator: Lian Leng Low
- Email: low.lian.leng@singhealth.com.sg
- Phone: 63265872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.