Loop T2D Observational Study

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT05951569
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-06-20
• Status Verified: 2023-07
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-19
• Primary Completion: 2023-09-08
• Study Completion: 2023-09-08
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events	Up to 3 months	Number of DKA events and event outcomes. DKA events are defined as hospitalization with documentation of arterial blood pH \<7.30 or venous pH \<7.24 or serum bicarbonate (or CO2) \<15.
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events	Up to 3 months	Number of severe hypoglycemic events and event outcomes. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
Measure of Loop Safety by Self-Report of Hospitalization Events	Up to 3 months	Number of hospitalizations

Trial Locations

Locations (1)

Jaeb Center for Health Research; 🇺🇸 Tampa, Florida, United States