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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028139
• Other study ID #: 202208-00017
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Singapore General Hospital
• Contact: Lian Leng Low
• Phone: 63265872
• Email: low.lian.leng[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

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.
• 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.

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore
Singapore	Sengkang General Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Singapore General Hospital	National Heart Centre Singapore, Sengkang General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	HbA1c over 6 months	6 months
Secondary	Physical activity as measured by number of steps	Physical activity over 6 months	6 months
Secondary	Physical activity as measured by moderate to vigorous active minutes	Physical activity over 6 months	6 months
Secondary	Physical activity as measured by GPAQ	Physical activity over 6 months	6 months
Secondary	Diet as measured by DASH	Diet quality over 6 months	6 months
Secondary	Sugar sweetened beverages intake	Sugar sweetened beverages intake over 6 months	6 months
Secondary	Patient activation score as measured by patient activation measure	Difference in patient activation score between intervention and control over 6 months	6 months
Secondary	Medication adherence as measured by DOSE-Nonadherence scale	Difference in medication adherence between intervention and control over 6 months	6 months
Secondary	Quality of life as measured by EQ-5D-5L	Difference in quality of life between intervention and control over 6 months	6 months
Secondary	Healthcare cost as measured by cost of consultations, lab tests, medications, admission	Healthcare cost over 6 months	6 months
Secondary	Healthcare cost as measured by WPAI	Healthcare cost over 6 months	6 months