Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous glucose monitoring and health coaching
EMPOWER mobile app
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
HbA1c
HbA1c over 6 months
Secondary Outcome Measures
Physical activity as measured by number of steps
Physical activity over 6 months
Physical activity as measured by moderate to vigorous active minutes
Physical activity over 6 months
Physical activity as measured by GPAQ
Physical activity over 6 months
Diet as measured by DASH
Diet quality over 6 months
Sugar sweetened beverages intake
Sugar sweetened beverages intake over 6 months
Patient activation score as measured by patient activation measure
Difference in patient activation score between intervention and control over 6 months
Medication adherence as measured by DOSE-Nonadherence scale
Difference in medication adherence between intervention and control over 6 months
Quality of life as measured by EQ-5D-5L
Difference in quality of life between intervention and control over 6 months
Healthcare cost as measured by cost of consultations, lab tests, medications, admission
Healthcare cost over 6 months
Healthcare cost as measured by WPAI
Healthcare cost over 6 months
Full Information
NCT ID
NCT06028139
First Posted
August 28, 2023
Last Updated
October 23, 2023
Sponsor
Singapore General Hospital
Collaborators
Sengkang General Hospital, National Heart Centre Singapore
1. Study Identification
Unique Protocol Identification Number
NCT06028139
Brief Title
Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
Official Title
Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Sengkang General Hospital, National Heart Centre Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Continuous glucose monitoring and health coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
EMPOWER mobile app
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
HbA1c over 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Physical activity as measured by number of steps
Description
Physical activity over 6 months
Time Frame
6 months
Title
Physical activity as measured by moderate to vigorous active minutes
Description
Physical activity over 6 months
Time Frame
6 months
Title
Physical activity as measured by GPAQ
Description
Physical activity over 6 months
Time Frame
6 months
Title
Diet as measured by DASH
Description
Diet quality over 6 months
Time Frame
6 months
Title
Sugar sweetened beverages intake
Description
Sugar sweetened beverages intake over 6 months
Time Frame
6 months
Title
Patient activation score as measured by patient activation measure
Description
Difference in patient activation score between intervention and control over 6 months
Time Frame
6 months
Title
Medication adherence as measured by DOSE-Nonadherence scale
Description
Difference in medication adherence between intervention and control over 6 months
Time Frame
6 months
Title
Quality of life as measured by EQ-5D-5L
Description
Difference in quality of life between intervention and control over 6 months
Time Frame
6 months
Title
Healthcare cost as measured by cost of consultations, lab tests, medications, admission
Description
Healthcare cost over 6 months
Time Frame
6 months
Title
Healthcare cost as measured by WPAI
Description
Healthcare cost over 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lian Leng Low
Phone
63265872
Email
low.lian.leng@singhealth.com.sg
12. IPD Sharing Statement
Learn more about this trial
Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
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