Control:Diabetes Pilot Study I

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04158921
• Other study ID #: controldiabetes01
• Status: Terminated
• Phase: N/A
• Start date: November 7, 2019
• Est. completion date: July 20, 2022

Study information

• Verified date: June 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Insulin Treated Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in blood glucose.	As recorded by the patient in the app.	Measured between the first two weeks and the last two weeks of the study.
Secondary	The change in the number of hypoglycemic episodes.	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.