Control:Diabetes Pilot Study I

Mass General Brigham

Status: Terminated

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

Treatments: Other: Control:Diabetes mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT04158921

controldiabetes01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

The Control:Diabetes mobile app for Diabetes self-management.

Other group

Description:

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.

Treatment:

Other: Control:Diabetes mobile app