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Due to the inability to recruit the required number of participants, the study has been terminated.
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| Name | Class |
|---|---|
| MOUNT SINAI HOSPITAL | OTHER |
| University of Toronto | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Mobile application plus standard of care |
|
| Control Group | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile application for diabetes self-management | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline to 12 months | Baseline, 3, 6, 9 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Baseline, 3, 6, 9 and 12 months | |
| Weight | Baseline, 3, 6, 9 and 12 months | |
| Cholesterol (LDL and total) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph A Cafazzo, PEng, PhD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5T3L9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27542325 | Derived | Goyal S, Lewis G, Yu C, Rotondi M, Seto E, Cafazzo JA. Evaluation of a Behavioral Mobile Phone App Intervention for the Self-Management of Type 2 Diabetes: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2016 Aug 19;5(3):e174. doi: 10.2196/resprot.5959. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline, 6 and 12 months |
| Medication changes | 3, 6, 9 and 12 months |
| Glycemic excursions | 3, 6, 9 and 12 months |
| BMI | 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 |
| D001519 | Behavior |