The Loop Observational Study (LOS)

Jaeb Center for Health Research

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Loop

Study type: Observational

Funder types: Other

Identifiers

NCT03838900

LOOP

Details and patient eligibility

About

An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the Loop DIY automated insulin delivery system.

Full description

The study will include both adults and youth in the United States, with a recruitment goal of at least 300-1,250 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and psychosocial and user experience/treatment satisfaction surveys.

Online forms will allow participants to report weekly device issues and serious adverse events including severe hypoglycemia, diabetic ketoacidosis, and hospitalizations. General data updates will be obtained after three, six, and 12 months (and every six months thereafter if study participation continues). A fingerstick blood sample will be collected for HbA1c measurement after three months for cohort A and after six and 12 months for both cohorts. Quality-of-life/psychosocial and treatment satisfaction questionnaires will be completed after six and 12 months; new users also will complete questionnaires after 3 months. Virtual focus groups will be completed within the first three months of starting Loop and at 12 months.

Enrollment: 1,212 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes
• Currently have, or have ordered, the hardware devices necessary to use Loop
• Currently use Loop or have plans to start using Loop for insulin delivery
• Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data and complete questionnaires that are part of the protocol
• Resident of U.S.

Exclusion criteria

• None

Trial design

1,212 participants in 2 patient groups

Cohort A

Description:

Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment.

Treatment:

Device: Loop

Cohort B

Description:

Participants who have been using Loop 7 or more days at the time of enrollment.

Treatment:

Device: Loop