Control:Diabetes Pilot Study I

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 1; Insulin Treated Type 2 Diabetes Mellitus

• Registration Number: NCT04158921
• Lead Sponsor: Brigham and Women's Hospital

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 Timeline

• Study Start: 2019-11-07
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Primary Completion: 2022-07-20
• Study Completion: 2022-07-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The mean change in blood glucose.	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

Name	Time	Method
The change in the number of hypoglycemic episodes.	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States