Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes mellitus, Randomized controlled trial, Primary care, Physical activity, Lifestyle, Blood glucose, Mobile health, Hb A1c, Self-management
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.
Interventions
BEHAVIORALMobile application for diabetes self-management
Sponsors
MOUNT SINAI HOSPITAL
University of Toronto
Canadian Institutes of Health Research (CIHR)
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to 12 months | Baseline, 3, 6, 9 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Weight | Baseline, 3, 6, 9 and 12 months |
| Cholesterol (LDL and total) | Baseline, 6 and 12 months |
| Medication changes | 3, 6, 9 and 12 months |
| Glycemic excursions | 3, 6, 9 and 12 months |
| Blood pressure | Baseline, 3, 6, 9 and 12 months |
| Diabetes Distress Scale | Baseline, 6 and 12 months |
| Diabetes Empowerment Scale | Baseline, 6 and 12 months |
| Summary of Diabetes Self-Care Activities | Baseline, 6 and 12 months |
| BMI | Baseline, 3, 6, 9 and 12 months |
Countries
Canada
Outcome results
None listed