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| Name | Class |
|---|---|
| Sengkang General Hospital | OTHER |
| National Heart Centre Singapore | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring and health coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c over 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity as measured by number of steps | Physical activity over 6 months | 6 months |
| Physical activity as measured by moderate to vigorous active minutes | Physical activity over 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lian Leng Low | Contact | 63265872 | low.lian.leng@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Recruiting | Singapore | 486838 | Singapore |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| EMPOWER mobile app | Behavioral | 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. |
|
| 6 months |
| Physical activity as measured by GPAQ | Physical activity over 6 months | 6 months |
| Diet as measured by DASH | Diet quality over 6 months | 6 months |
| Sugar sweetened beverages intake | Sugar sweetened beverages intake over 6 months | 6 months |
| Patient activation score as measured by patient activation measure | Difference in patient activation score between intervention and control over 6 months | 6 months |
| Medication adherence as measured by DOSE-Nonadherence scale | Difference in medication adherence between intervention and control over 6 months | 6 months |
| Quality of life as measured by EQ-5D-5L | Difference in quality of life between intervention and control over 6 months | 6 months |
| Healthcare cost as measured by cost of consultations, lab tests, medications, admission | Healthcare cost over 6 months | 6 months |
| Healthcare cost as measured by WPAI | Healthcare cost over 6 months | 6 months |
| National Heart Centre Singapore | Recruiting | Singapore | Singapore |
|
| Sengkang General Hospital | Recruiting | Singapore | Singapore |
|
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |