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

April 16, 2024 updated by: Singapore General Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 6 months
HbA1c over 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity as measured by number of steps
Time Frame: 6 months
Physical activity over 6 months
6 months
Physical activity as measured by moderate to vigorous active minutes
Time Frame: 6 months
Physical activity over 6 months
6 months
Physical activity as measured by GPAQ
Time Frame: 6 months
Physical activity over 6 months
6 months
Diet as measured by DASH
Time Frame: 6 months
Diet quality over 6 months
6 months
Sugar sweetened beverages intake
Time Frame: 6 months
Sugar sweetened beverages intake over 6 months
6 months
Patient activation score as measured by patient activation measure
Time Frame: 6 months
Difference in patient activation score between intervention and control over 6 months
6 months
Medication adherence as measured by DOSE-Nonadherence scale
Time Frame: 6 months
Difference in medication adherence between intervention and control over 6 months
6 months
Quality of life as measured by EQ-5D-5L
Time Frame: 6 months
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
Time Frame: 6 months
Healthcare cost over 6 months
6 months
Healthcare cost as measured by WPAI
Time Frame: 6 months
Healthcare cost over 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Collaborators

Sengkang General Hospital
National Heart Centre Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 3, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202208-00017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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