Observational Study of AID Systems in Pregnant Individuals with Type 1 Diabetes
This observational study aims to understand how automated insulin delivery (AID) systems affect pregnant individuals with type 1 diabetes (T1D) and their babies. Researchers will compare those using commercially available AID systems with those using open-source AID systems. The study will look at outcomes like whether babies are born large for gestational age (LGA), the emotional impact of T1D (measured by the Type 1 Diabetes Distress Assessment Scale or T1-DDAS), and high blood pressure during pregnancy (hypertensive disorders of pregnancy or HDP). You may be able to join if you are pregnant, have T1D diagnosed before pregnancy, and are currently using an AID system. The study plans to enroll 1000 participants.
- Study design
- This is an observational study, meaning researchers will watch and collect information without giving specific treatments. It plans to include 1000 pregnant individuals.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from enrollment until 8 weeks after giving birth for some outcomes, and until delivery for others.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Commercial or Open Source Closed Loop Impact on Pregnancy Study
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Nasim Sobhani, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Large for gestational age (LGA)At delivery
Primary neonatal outcome. LGA defined as birth weight \> 90th percentile for gestational age
- Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS)From enrollment to 8 weeks postpartum
Primary behavioral outcome. Score ranges from 1-5. Higher scores indicate higher degrees of diabetes distress.
- Hypertensive disorders of pregnancy (HDP)From enrollment to 8 weeks postpartum.
Primary maternal outcome. As defined by the American College of Obstetricians and Gynecologists (ACOG).
- Time in pregnancy-specific range (psTIR)From enrollment to 8 weeks postpartum.
Primary glycemic outcome. Defined as percent of time spent with sensor glucose in pregnancy range of 63-140 mg/dL.