Clinical trial Recruiting at 1 site Observational Ages 18 and up Women only

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.

More Type 1 Diabetes trials

Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment1000 (estimated)
SponsorUniversity of California, San Francisco
Academic / other
Locations1 site (San Francisco, California)
StatusRecruiting
StartedMarch 13, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedJuly 27, 2026
Trial IDNCT06654713 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.