Control:Diabetes Pilot Study I

June 16, 2023 updated by: Alexander Turchin, Brigham and Women's Hospital

Control:Diabetes - a Mobile App to Improve Glycemic Control in Patients With Diabetes

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured between the first two weeks and the last two weeks of the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured every week between the two weeks prior to the study entry and the last two weeks of study follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2019

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • controldiabetes01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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