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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
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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 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

    First Posted
    August 28, 2023
    Last Updated
    October 23, 2023
    Sponsor
    Singapore General Hospital
    Collaborators
    Sengkang General Hospital, National Heart Centre Singapore
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    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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