Trials / Completed
CompletedNCT05951569
Loop T2D Observational Study
An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 8 (actual)
- Sponsor
- Jaeb Center for Health Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Community-Derived Open-Source Automated Insulin Delivery Loop System | The Loop System consists of an insulin pump and a Dexcom CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system. |
Timeline
- Start date
- 2023-06-20
- Primary completion
- 2023-09-08
- Completion
- 2023-09-08
- First posted
- 2023-07-19
- Last updated
- 2023-10-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05951569. Inclusion in this directory is not an endorsement.