Impact of Automated Insulin Delivery on Pregnancy Outcomes
Official title: Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
Run by University of California, San Francisco · NCT06654713 · Data updated 2026-11-12
This study looks at how using automated insulin delivery systems during pregnancy affects the health of both mothers with type 1 diabetes and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT06654713 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant individuals diagnosed with type 1 diabetes who are actively using an automated insulin delivery system.
✕Probably not a fit
Patients with other forms of diabetes, such as gestational diabetes or type 2 diabetes, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to understand the effects of automated insulin delivery (AID) systems on pregnant individuals with type 1 diabetes. Researchers will compare maternal and neonatal outcomes, glycemic control, and behavioral and emotional health between users of commercial and open-source AID systems. Participants will share their AID system data remotely and complete online surveys, while also allowing access to their medical records for comprehensive analysis.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into optimizing insulin delivery for pregnant individuals with type 1 diabetes, potentially improving maternal and neonatal health outcomes.
How similar studies have gone: While there is ongoing research in the area of automated insulin delivery, this specific comparison of commercial versus open-source systems in a pregnant population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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University of California, San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Nasim Sobhani, MD — University of California, San Francisco
- Study coordinator: Primary Investigator
- Email: cosclipstudy@ucsf.edu
- Phone: (415) 307-9319
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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NOURISH: a community partnership to improve nutrition and glycemic control in pregnant women with pregestational diabetes
Aiming to test a healthcare-community program that delivers healthy food weekly and provides nutrition education to pregnant women with type 1 or type 2 diabetes who have food insecurity, to improve blood sugar and pregnancy outcomes.
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Permissive versus strict blood sugar control during labor for pregnant people with type 1 diabetes
This trial will test whether allowing slightly higher blood sugars (70–140 mg/dL) during labor is as safe for newborns as keeping tighter control (70–110 mg/dL) for pregnant people with type 1 diabetes using hybrid closed‑loop insulin systems.
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Observational study on the safety of relugolix therapy in pregnant women
This study is trying to see if relugolix therapy is safe for pregnant women and their babies by looking at health outcomes during and after pregnancy.
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Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity
This study tests whether weekly semaglutide changes body composition in adults with type 1 diabetes who are overweight or obese, compared with a placebo over 24 weeks.
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Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes
This study tests a new extended wear sensor and algorithm in people with type 1 or type 2 diabetes to see how well it works across adults and children.
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CGM-guided carb awareness education for adults with Type 1 diabetes
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.