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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06028139
Other study ID # 202208-00017
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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