Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes

Study Overview
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Brief Summary
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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).

Official Title
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Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Continuous glucose monitoring and health coaching
* Behavioral: EMPOWER mobile app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Continuous glucose monitoring and health coaching<br>* 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.<br>Behavioral: EMPOWER mobile app<br>* 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.<br>|
| Other: Control<br> | Behavioral: EMPOWER mobile app<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c over 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |