Commercial or Open Source Closed Loop Impact on Pregnancy Study
NCT ID: NCT06654713
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2025-03-13
2029-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Commercial AID system
Pregnant individuals with type 1 diabetes (T1D) using commercially available automated insulin delivery (AID) systems for glycemic management in pregnancy
Commercial AID system
AID system that is commercially available and FDA approved for use
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
Open 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
Interventions
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Commercial AID system
AID system that is commercially available and FDA approved for use
Open 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
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 1 diabetes (T1D) prior to pregnancy
* Active use of automated insulin delivery (AID) system
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Nasim Sobhani, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-42036
Identifier Type: -
Identifier Source: org_study_id
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