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

Sponsor

Singapore General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06028139

Collaborator

Sengkang General Hospital (Other), National Heart Centre Singapore (Other)

400

Enrollment

Arms

17.1

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: Continuous glucose monitoring and health coaching Behavioral: EMPOWER mobile app	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Behavioral: Continuous 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. Behavioral: EMPOWER 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. .
Other: Control	Behavioral: EMPOWER 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. .

Arm

Intervention/Treatment

Experimental: Intervention

Behavioral: Continuous 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.

Behavioral: EMPOWER 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. .

Other: Control

Behavioral: EMPOWER mobile app

Outcome Measures

Primary Outcome Measures

HbA1c [6 months]
HbA1c over 6 months

Secondary Outcome Measures

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
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
Patient activation score as measured by patient activation measure [6 months]
Difference in patient activation score between intervention and control 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged 21 years and above
Have diagnosis of type 2 diabetes mellitus
Provided informed consent
Have near-field communication (NFC) compatible phones

Exclusion Criteria:

Significant cognitive impairment
Other conditions that may preclude participants from wearing CGM devices

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Singapore General Hospital
Sengkang General Hospital
National Heart Centre Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Singapore General Hospital

ClinicalTrials.gov Identifier:

NCT06028139

Other Study ID Numbers:

202208-00017

First Posted:

Sep 8, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 8, 2023