Control:Diabetes Pilot Study I

Study 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.

Official Title
-----------------
Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 1, Insulin Treated Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Control:Diabetes mobile app


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The Control:Diabetes mobile app for Diabetes self-management.<br>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. | Other: Control:Diabetes mobile app<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in blood glucose. | As recorded by the patient in the app. | Measured between the first two weeks and the last two weeks of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the number of hypoglycemic episodes. | Number of low blood sugar episodes as reported in the study surveys. | Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin Therapy, Diabetes Mellitus, Glycemic Control, Hyperglycemia, Hypoglycemia, Health Education, Self-Management, Lifestyle