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Commercial or Open Source Closed Loop Impact on Pregnancy Study

RECRUITINGSponsored by University of California, San Francisco
Actively Recruiting
SponsorUniversity of California, San Francisco
Started2025-03-13
Est. completion2029-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06654713

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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)

Conditions5

DiabetesInsulin Dependent DiabetesPregnancy RelatedPregnancy, High RiskType 1 Diabetes

Locations1 site

University of California, San Francisco
San Francisco, California, 94158
Nasim Sobhani415-307-9319COSCLIPStudy@UCSF.edu

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