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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: EMPOWER mobile app; Behavioral: Continuous glucose monitoring and health coaching

• Registration Number: NCT06028139
• Lead Sponsor: Singapore General Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-03
• Study First Posted: 2023-09-08
• Study Start: 2023-10-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	EMPOWER mobile app	-
Intervention	Continuous glucose monitoring and health coaching	-
Intervention	EMPOWER mobile app	-

Primary Outcome Measures

Name	Time	Method
HbA1c	6 months	HbA1c over 6 months

Secondary Outcome Measures

Name	Time	Method
Physical activity as measured by GPAQ	6 months	Physical activity over 6 months
Sugar sweetened beverages intake	6 months	Sugar sweetened beverages intake 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
Patient activation score as measured by patient activation measure	6 months	Difference in patient activation score 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
Medication adherence as measured by DOSE-Nonadherence scale	6 months	Difference in medication adherence between intervention and control over 6 months
Physical activity as measured by number of steps	6 months	Physical activity over 6 months
Physical activity as measured by moderate to vigorous active minutes	6 months	Physical activity over 6 months
Diet as measured by DASH	6 months	Diet quality over 6 months
Healthcare cost as measured by WPAI	6 months	Healthcare cost over 6 months

Trial Locations

Locations (3)

Sengkang General Hospital; 🇸🇬 Singapore, Singapore

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore