Control:Diabetes Pilot Study I
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04158921|
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Insulin Treated Type 2 Diabetes Mellitus Diabetes Mellitus, Type 1||Other: Control:Diabetes mobile app||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes|
|Actual Study Start Date :||November 7, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||April 30, 2020|
The Control:Diabetes mobile app for Diabetes self-management.
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
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.
- 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.
- The change in the number of hypoglycemic episodes. [ Time Frame: Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up. ]Number of low blood sugar episodes as reported in the study surveys.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158921
|Contact: Luisa Florez, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Luisa Florez, MD 857-288-8671 email@example.com|