RecruitingNCT06654713

Commercial or Open Source Closed Loop Impact on Pregnancy Study

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

Sponsor

University of California, San Francisco

Enrollment

1,000 participants

Start Date

Mar 13, 2025

Study Type

OBSERVATIONAL

Conditions

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

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different automated insulin delivery (AID) systems — sometimes called closed-loop or artificial pancreas systems — in pregnant women with type 1 diabetes, to see how well various commercial and open-source devices control blood sugar during pregnancy. **You may be eligible if...** - You are pregnant - You have type 1 diabetes (diagnosed before pregnancy) - You are actively using an automated insulin delivery system **You may NOT be eligible if...** - You have gestational diabetes, type 2 diabetes, or another form of diabetes - You are not currently using an automated insulin delivery system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCommercial AID system

AID system that is commercially available and FDA approved for use

OTHEROpen 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

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