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

Singapore Health Services (SingHealth)

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Continuous glucose monitoring and health coaching; Behavioral: EMPOWER mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT06028139

202208-00017

Details and patient eligibility

About

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).

Enrollment: 400 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Behavioral: Continuous glucose monitoring and health coaching

Behavioral: EMPOWER mobile app

Control

Other group

Treatment:

Behavioral: EMPOWER mobile app