Control:Diabetes Pilot Study I
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ClinicalTrials.gov Identifier: NCT04158921 |
Recruitment Status : Unknown
Verified November 2019 by Alexander Turchin, Brigham and Women's Hospital.
Recruitment status was: Recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
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Condition or disease | Intervention/treatment | Phase |
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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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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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.
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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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158921
Contact: Luisa Florez, MD | 857-288-8671 | controldiabetes@bwh.harvard.edu |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Luisa Florez, MD 857-288-8671 controldiabetes@bwh.harvard.edu |
Responsible Party: | Alexander Turchin, Associate Professor of Medicine, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT04158921 |
Other Study ID Numbers: |
controldiabetes01 |
First Posted: | November 12, 2019 Key Record Dates |
Last Update Posted: | November 12, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diabetes Mellitus Insulin Therapy Glycemic Control Hyperglycemia |
Hypoglycemia Health Education Self-Management Lifestyle |
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |