Diabetes Mellitus, Type 2
Conditions
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).
Interventions
BEHAVIORALContinuous glucose monitoring and health coaching
Each CGM device will work for 14 days. The participants will use the CGM devices for the first two-week period in the first three months of the trial, and the first two-week period of the second three months of the trial. Participants will interact with health coach throughout the study duration.
BEHAVIORALEMPOWER mobile app
Nudges will be delivered through the EMPOWER mobile app. Participants will log lifestyle information such as diet and physical activity, and clinical information such as medication and HbA1c levels through the EMPOWER mobile app.
Sponsors
Sengkang General Hospital
National Heart Centre Singapore
Singapore General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 6 months | HbA1c over 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity as measured by moderate to vigorous active minutes | 6 months | Physical activity over 6 months |
| Physical activity as measured by GPAQ | 6 months | Physical activity over 6 months |
| Diet as measured by DASH | 6 months | Diet quality over 6 months |
| Sugar sweetened beverages intake | 6 months | Sugar sweetened beverages intake over 6 months |
| Physical activity as measured by number of steps | 6 months | Physical activity over 6 months |
| Medication adherence as measured by DOSE-Nonadherence scale | 6 months | Difference in medication adherence between intervention and control over 6 months |
| Quality of life as measured by EQ-5D-5L | 6 months | Difference in quality of life between intervention and control over 6 months |
| Healthcare cost as measured by cost of consultations, lab tests, medications, admission | 6 months | Healthcare cost over 6 months |
| Healthcare cost as measured by WPAI | 6 months | Healthcare cost over 6 months |
| Patient activation score as measured by patient activation measure | 6 months | Difference in patient activation score between intervention and control over 6 months |
Countries
Singapore
Contacts
Primary ContactLian Leng Low
Outcome results
None listed