Status:
COMPLETED
The Loop Observational Study
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
Stanford University
Tidepool Project
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
Brief Summary
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.
Detailed 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 metr...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
January 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2020
Estimated Enrollment :
1212 Patients enrolled
Trial Details
Trial ID
NCT03838900
Start Date
January 17 2019
End Date
April 25 2020
Last Update
August 14 2020
Active Locations (1)
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1
Jaeb Center for Health Research
Tampa, Florida, United States, 33647