NCT06654713 Commercial or Open Source Closed Loop Impact on Pregnancy Study
| NCT ID | NCT06654713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-03-13 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Nasim Sobhani, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06654713 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06654713 currently recruiting?
Yes, NCT06654713 is actively recruiting participants. Contact the research team at cosclipstudy@ucsf.edu for enrollment information.
Where is the NCT06654713 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06654713 clinical trial?
NCT06654713 is sponsored by University of California, San Francisco. The principal investigator is Nasim Sobhani, MD at University of California, San Francisco. The trial plans to enroll 1,000 participants.
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