Loop T2D Observational Study

Jaeb Center for Health Research

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Community-Derived Open-Source Automated Insulin Delivery Loop System

Study type: Observational

Funder types: Other

Identifiers

NCT05951569

T2D 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 community-derived OS-AID Loop System on adults with type 2 diabetes.

Full description

The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 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 user experience/treatment satisfaction surveys.

Follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Age ≥18 years old
• Currently using any version of Loop other than v3.0.0 or planning to start using any version of Loop other than v3.0.0 Loop within the next 30 days
• Willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol
• Resident of the US
• English speaking/reading
• Access to email/phone

Exclusion criteria

• None