Impact of Automated Insulin Delivery on Pregnancy Outcomes
Commercial or Open Source Closed Loop Impact on Pregnancy (COSCLIP) Study
University of California, San Francisco · NCT06654713
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06654713 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals diagnosed with type 1 diabetes who are actively using an automated insulin delivery system.
Not a fit: Patients with other forms of diabetes, such as gestational diabetes or type 2 diabetes, may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes, Pregnancy, High Risk, Insulin Dependent Diabetes, Pregnancy Related