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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
Sponsor:
Information provided by (Responsible Party):
Alexander Turchin, Brigham and Women's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insulin Treated Type 2 Diabetes Mellitus Diabetes Mellitus, Type 1 Other: Control:Diabetes mobile app Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Luisa Florez, MD 857-288-8671 controldiabetes@bwh.harvard.edu

Locations
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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   
Sponsors and Collaborators
Brigham and Women's Hospital
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Turchin, Brigham and Women's Hospital:
Diabetes Mellitus
Insulin Therapy
Glycemic Control
Hyperglycemia
 Hypoglycemia
Health Education
Self-Management
Lifestyle
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases