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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. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Alexander Turchin, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE November 7, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE November 7, 2019
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Control:Diabetes Pilot Study I
Official Title  ICMJE Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Insulin Treated Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 1
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Control:Diabetes mobile app
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 7, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04158921
Other Study ID Numbers  ICMJE controldiabetes01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Alexander Turchin, Brigham and Women's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Brigham and Women's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brigham and Women's Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP