Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
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).
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National Heart Centre Singapore | Singapore | |
Singapore | Sengkang General Hospital | Singapore | |
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital | National Heart Centre Singapore, Sengkang General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c | HbA1c over 6 months | 6 months | |
Secondary | Physical activity as measured by number of steps | Physical activity over 6 months | 6 months | |
Secondary | Physical activity as measured by moderate to vigorous active minutes | Physical activity over 6 months | 6 months | |
Secondary | Physical activity as measured by GPAQ | Physical activity over 6 months | 6 months | |
Secondary | Diet as measured by DASH | Diet quality over 6 months | 6 months | |
Secondary | Sugar sweetened beverages intake | Sugar sweetened beverages intake over 6 months | 6 months | |
Secondary | Patient activation score as measured by patient activation measure | Difference in patient activation score between intervention and control over 6 months | 6 months | |
Secondary | Medication adherence as measured by DOSE-Nonadherence scale | Difference in medication adherence between intervention and control over 6 months | 6 months | |
Secondary | Quality of life as measured by EQ-5D-5L | Difference in quality of life between intervention and control over 6 months | 6 months | |
Secondary | Healthcare cost as measured by cost of consultations, lab tests, medications, admission | Healthcare cost over 6 months | 6 months | |
Secondary | Healthcare cost as measured by WPAI | Healthcare cost over 6 months | 6 months |
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