Evaluation of an mHealth Behavioural Intervention for the Self-Management for Type 2 Diabetes

Not Applicable

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Mobile application for diabetes self-management

• Registration Number: NCT02370719
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this study is to evaluate a patient-centered diabetes self-management mobile application (app), which was developed with feedback from both patients and healthcare providers. During the 12 month randomized control trial, participants in the intervention group will be provided with a mobile phone and commercial home medical devices, such as a weight scale, glucometer and activity monitor. The measurements taken from the medical devices will wirelessly transfer to the mobile phone, where the app will assess the data and provide patients with actionable self-management knowledge. The proposed intervention may be helpful in increasing adherence to recommended self-care practices, improving self-efficacy, and enhancing the overall patient experience.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-25
• Study Start: 2015-06-28
• Primary Completion: 2017-10-28
• Study Completion: 2017-10-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• English-speaking individuals
• Diagnosed with non-insulin requiring type 2 diabetes
• Outpatients
• Baseline A1c of 7.5% or higher

Exclusion Criteria

• Patients who are deemed unable to use a mobile phone (e.g. due to vision problems), and/or to comply with home monitoring (e.g. suffering from anxiety or depression)
• Diabetes duration <1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Mobile application for diabetes self-management	Mobile application plus standard of care

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to 12 months	Baseline, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Diabetes Distress Scale	Baseline, 6 and 12 months
Blood pressure	Baseline, 3, 6, 9 and 12 months
Cholesterol (LDL and total)	Baseline, 6 and 12 months
Summary of Diabetes Self-Care Activities	Baseline, 6 and 12 months
Medication changes	3, 6, 9 and 12 months
Weight	Baseline, 3, 6, 9 and 12 months
Glycemic excursions	3, 6, 9 and 12 months
BMI	Baseline, 3, 6, 9 and 12 months
Diabetes Empowerment Scale	Baseline, 6 and 12 months

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada