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Commercial or Open Source Closed Loop Impact on Pregnancy Study
Sponsor: University of California, San Francisco
Summary
The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are: * What are the maternal and neonatal outcomes with AID system use in pregnancy? * What are the glycemic outcomes with AID system use in pregnancy? * What are the behavioral and emotional outcomes with AID system use in pregnancy? Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems. Participants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.
Official title: Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2025-03-13
Completion Date
2029-12-31
Last Updated
2025-05-07
Healthy Volunteers
No
Interventions
Commercial AID system
AID system that is commercially available and FDA approved for use
Open source AID system
AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor
Locations (1)
University of California, San Francisco
San Francisco, California, United States