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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02370719
• Other study ID #: BantII
• Status: Terminated
• Phase: N/A
• Start date: June 28, 2015
• Est. completion date: October 28, 2017

Study information

• Verified date: September 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: October 28, 2017
• Est. primary completion date: October 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Mobile application for diabetes self-management

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR), MOUNT SINAI HOSPITAL, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to 12 months		Baseline, 3, 6, 9 and 12 months
Secondary	Blood pressure		Baseline, 3, 6, 9 and 12 months
Secondary	Weight		Baseline, 3, 6, 9 and 12 months
Secondary	Cholesterol (LDL and total)		Baseline, 6 and 12 months
Secondary	Medication changes		3, 6, 9 and 12 months
Secondary	Glycemic excursions		3, 6, 9 and 12 months
Secondary	BMI		Baseline, 3, 6, 9 and 12 months
Secondary	Diabetes Distress Scale		Baseline, 6 and 12 months
Secondary	Diabetes Empowerment Scale		Baseline, 6 and 12 months
Secondary	Summary of Diabetes Self-Care Activities		Baseline, 6 and 12 months