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

September 2, 2021 updated by: Joseph Cafazzo, University Health Network, Toronto

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T3L9
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Standard of care
Experimental: Intervention Group
Mobile application plus standard of care
Behavioral: Mobile application for diabetes self-management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c from baseline to 12 months
Time Frame: Baseline, 3, 6, 9 and 12 months
Baseline, 3, 6, 9 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)
University of Toronto
MOUNT SINAI HOSPITAL

Investigators

  • Principal Investigator: Joseph A Cafazzo, PEng, PhD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 28, 2015

Primary Completion (Actual)

October 28, 2017

Study Completion (Actual)

October 28, 2017

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BantII

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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