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

NCT ID: NCT06028139

Last Updated: 2024-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2024-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Continuous glucose monitoring and health coaching

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Control

Group Type OTHER

EMPOWER mobile app

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sengkang General Hospital

OTHER

Sponsor Role collaborator

National Heart Centre Singapore

OTHER

Sponsor Role collaborator

Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status RECRUITING

National Heart Centre Singapore

Singapore, , Singapore

Site Status RECRUITING

Sengkang General Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Lian Leng Low

Role: CONTACT

Facility Contacts

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Lian Leng Low

Role: primary

Weiting Huang

Role: primary

Sueziani Binte Zainudin

Role: primary

Other Identifiers

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202208-00017

Identifier Type: -

Identifier Source: org_study_id

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