Commercial or Open Source Closed Loop Impact on Pregnancy Study

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06654713
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Commercial AID system — OTHER
    AID system that is commercially available and FDA approved for use
  • Open source AID system — OTHER
    AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor

Study Details

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.

Key Dates

Start date
Mar 13, 2025
Status verified
May 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Commercial AID system
    Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy
  • Arm: Open source AID system
    Pregnant individuals with type 1 diabetes T1D) using open source automated insulin delivery (AID) systems (also known as do-it-yourself AID systems or hacked AID systems) for glycemic management in pregnancy

Primary Outcome Measure

Large for gestational age (LGA) [ Time Frame: At delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Nasim Sobhani
[email protected]
415-307-9319

Find similar trials in San Francisco, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of California, San Francisco· San Francisco, CA

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