Control:Diabetes Pilot Study I

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.

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.

Diabetes Mellitus, Insulin Therapy, Glycemic Control, Hyperglycemia, Hypoglycemia, Health Education, Self-Management, Lifestyle

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.

The Control:Diabetes app will encourage patients to: a) predict their blood glucose level at a particular time point in the future (e.g. the next morning); then b) enter their actual blood glucose levels when that time (the next morning) comes; and c) enter reasons for the discrepancy between prediction and reality, if the prediction was significantly (e.g. > 20%) different from the actual measurement. We hypothesize that by repeatedly encouraging disassembly of blood glucose changes into individual reasons (cognitive task analysis) while providing an incentive in the form of being able to more accurately predict blood glucose levels (operant conditioning), the app will prompt the patient to learn how various internal and environmental factors affect their blood glucose. They will then be able to adjust their behavior and medications to improve their blood glucose control.

Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.

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)