Commercial or Open Source Closed Loop Impact on Pregnancy Study

Last updated: May 6, 2025
Sponsor: University of California, San Francisco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Prevention

Diabetes Mellitus Types I And Ii

Treatment

Commercial AID system

Open source AID system

Clinical Study ID

NCT06654713
24-42036
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion criteria:

  • Pregnant

  • Diagnosis of type 1 diabetes (T1D) prior to pregnancy

  • Active use of automated insulin delivery (AID) system

Exclusion

Exclusion criteria:

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

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Commercial AID system
Phase:
Study Start date:
March 13, 2025
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • University of California, San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

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