NCT06654713

Commercial or Open Source Closed Loop Impact on Pregnancy Study

Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes
• Pregnancy, High Risk
• Insulin Dependent Diabetes
• Pregnancy Related

Interventions

Type	Name	Description
OTHER	Commercial AID system	AID system that is commercially available and FDA approved for use
OTHER	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

Timeline

• Start date: 2025-03-13
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2024-10-23
• Last updated: 2025-05-07

Locations

1 site across 1 country: United States