NCT06883344 Automated Insulin for Management of Intrapartum Glycemia
| NCT ID | NCT06883344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-12-05 with a primary completion date of 2028-12-31.
⚠ 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 clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are * What are the neonatal glycemic outcomes with use of AID systems during labor/delivery? * Do patients report higher birth satisfaction with use of AID systems during labor/delivery? * Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery? Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.
Eligibility Criteria
Inclusion Criteria: * Currently pregnant at ≥ 34 weeks * Known diagnosis of type 1 diabetes ≥ 1 year * Use of commercially available AID system since at least 28 weeks gestation * Singleton pregnancy * English- or Spanish-speaking Exclusion Criteria: * Multifetal gestation * Planned cesarean delivery * Use of medications known to interfere with glucose metabolism * Intrauterine fetal demise * Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare
Contact & Investigator
Nasim Sobhani, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06883344 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883344 currently recruiting?
Yes, NCT06883344 is actively recruiting participants. Contact the research team at dappresearch@ucsf.edu for enrollment information.
Where is the NCT06883344 trial being conducted?
This trial is being conducted at Los Angeles, United States, San Diego, United States, San Francisco, United States.
Who is sponsoring the NCT06883344 clinical trial?
NCT06883344 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 150 participants.
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