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History of Changes for Study: NCT04158921
Control:Diabetes Pilot Study I
Latest version (submitted November 7, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 7, 2019 None (earliest Version on record)
Comparison Format:

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Study NCT04158921
Submitted Date:  November 7, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: controldiabetes01
Brief Title: Control:Diabetes Pilot Study I
Official Title: Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2019
Overall Status: Unknown status [Previously: Recruiting]
Study Start: November 7, 2019
Primary Completion: March 31, 2020 [Anticipated]
Study Completion: April 30, 2020 [Anticipated]
First Submitted: November 7, 2019
First Submitted that
Met QC Criteria:
November 7, 2019
First Posted: November 12, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
November 7, 2019
Last Update Posted: November 12, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Brigham and Women's Hospital
Responsible Party: Principal Investigator
Investigator: Alexander Turchin
Official Title: Associate Professor of Medicine
Affiliation: Brigham and Women's Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Insulin Treated Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus
Insulin Therapy
Glycemic Control
Hyperglycemia
Hypoglycemia
Health Education
Self-Management
Lifestyle
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 70 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Locations: United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Contact:Contact: Luisa Florez, MD 857-288-8671 controldiabetes@bwh.harvard.edu
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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