Commercial or Open Source Closed Loop Impact on Pregnancy Study
Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
University of California, San Francisco
1,000 participants
Mar 13, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Pregnant
- Diagnosis of type 1 diabetes (T1D) prior to pregnancy
- Active use of automated insulin delivery (AID) system
Exclusion Criteria1
- Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)
Interventions
AID system that is commercially available and FDA approved for use
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06654713