Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Singapore General Hospital
- Enrollment
- 400
- Locations
- 3
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. This parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app EMPOWER and smartwatch, health coaching, and continuous glucose monitoring (CGM).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 21 years and above
- •Have diagnosis of type 2 diabetes mellitus
- •Provided informed consent
- •Have near-field communication (NFC) compatible phones
- •Able to engage in light physical activity (e.g., walking)
Exclusion Criteria
- •Significant cognitive impairment
- •Other conditions that may preclude participants from wearing CGM devices
Arms & Interventions
Control
Intervention: EMPOWER mobile app (Behavioral)
Intervention
Intervention: Continuous glucose monitoring and health coaching (Behavioral)
Intervention
Intervention: EMPOWER mobile app (Behavioral)
Outcomes
Primary Outcomes
HbA1c
Time Frame: 6 months
HbA1c over 6 months
Secondary Outcomes
- Physical activity as measured by GPAQ(6 months)
- Sugar sweetened beverages intake(6 months)
- Quality of life as measured by EQ-5D-5L(6 months)
- Patient activation score as measured by patient activation measure(6 months)
- Healthcare cost as measured by cost of consultations, lab tests, medications, admission(6 months)
- Medication adherence as measured by DOSE-Nonadherence scale(6 months)
- Physical activity as measured by number of steps(6 months)
- Physical activity as measured by moderate to vigorous active minutes(6 months)
- Diet as measured by DASH(6 months)
- Healthcare cost as measured by WPAI(6 months)