Actively Recruiting
Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
Led by University of California, San Francisco · Updated on 2025-05-07
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pregnant individuals with type 1 diabetes (T1D) who use automated insulin delivery (AID) systems to better understand how these systems affect pregnancy outcomes. The study compares those using commercially available AID systems with those using open source AID systems to see if there are differences in maternal, neonatal, glycemic, behavioral, and emotional health outcomes during pregnancy. Participants use either commercially approved AID systems or open source AID systems that customize insulin delivery by connecting insulin pumps with continuous glucose monitors. The study collects data remotely and includes groups based on the type of AID system used for managing blood sugar levels throughout pregnancy. Participants will share their AID system data remotely, complete online surveys about behavioral and emotional health, and authorize access to medical records. Researchers will measure outcomes such as large for gestational age babies at delivery, hypertensive disorders, time within pregnancy-specific blood sugar ranges, and diabetes distress from enrollment through 8 weeks after birth. Secondary outcomes include cesarean delivery rates, neonatal complications, pregnancy loss, and maternal hypoglycemia, with monitoring continuing up to 28 days or 8 weeks postpartum depending on the measure.
CONDITIONS
Brief Title
Commercial or Open Source Closed Loop Impact on Pregnancy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant
- Diagnosis of type 1 diabetes prior to pregnancy
- Active use of automated insulin delivery system
- Female gender
- Age 18 years or older
You will not qualify if you...
- Diagnosis of other types of diabetes such as gestational diabetes, type 2 diabetes, or monogenic diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From enrollment through delivery and up to 8 weeks postpartum
Participants using either commercial or open source automated insulin delivery systems are observed throughout pregnancy and up to 8 weeks postpartum to assess glycemic management and pregnancy outcomes.
Regular visits during pregnancy and postpartum period
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
Research Team
P
Primary Investigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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