Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insulin Treated Type 2 Diabetes Mellitus
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- The mean change in blood glucose.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a single arm open label pilot clinical trial that will assess patient-reported blood glucose levels before and after using the Control:Diabetes mobile app, while collecting user feedback and recommendations for further improvements to the app functionality and user interface. This study will enroll approximately 70 individuals with insulin-treated diabetes mellitus. The study will include two online surveys (baseline and exit), one study initiation phone call, and will also collect data entered by the users into the mobile app.
Detailed Description
The objectives of this study are to: * Test the hypothesis that patients with diabetes mellitus treated with insulin and elevated blood glucose will achieve better glycemic control after using the Control:Diabetes mobile app. * Test the hypothesis that patients with diabetes mellitus treated with insulin and frequent hypoglycemia will achieve lower frequency of hypoglycemia after using the Control:Diabetes mobile app.
Investigators
Alexander Turchin
Associate Professor of Medicine
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Diagnosis of Type 1 Diabetes or Type 2 Diabetes
- •Treatment with multiple daily insulin injections (MDII) or continuous subcutaneous insulin infusion (CSII)
- •Baseline HbA1c between 7% and 10.5% (as reported by the participant) and/or self- reported frequency of symptomatic hypoglycemia ≥ 3 times / week
- •Ownership of a smartphone running either Android or iOS operating system with an active data plan
Exclusion Criteria
- •Using a closed loop insulin delivery system (Medtronic 670G or OpenAPS)
Outcomes
Primary Outcomes
The mean change in blood glucose.
Time Frame: Measured between the first two weeks and the last two weeks of the study.
As recorded by the patient in the app.
Secondary Outcomes
- The change in the number of hypoglycemic episodes.(Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.)