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Commercial or Open Source Closed Loop Impact on Pregnancy Study

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

Who can join

Ages 18 and older · Women

Inclusion criteria:

* Pregnant
* Diagnosis of type 1 diabetes (T1D) prior to pregnancy
* Active use of automated insulin delivery (AID) system

Exclusion criteria:

* Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)

About the study

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.

What is being tested

• Commercial AID system (other)
• Open source AID system (other)

Sponsor: University of California, San Francisco · Participants: 1,000 · Started: Mar 13, 2025

Contact the study team

• Primary Investigator · Phone: (415) 307-9319

Official record on ClinicalTrials.gov — NCT06654713

Locations in the U.S.

Conditions

• Type 1 Diabetes

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.