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Search / Trial NCT06883344

Automated Insulin for Management of Intrapartum Glycemia

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Mar 12, 2025

Trial Information

Current as of May 10, 2025

Not yet recruiting

Keywords

Pregnancy Intrapartum Glycemic Management Neonatal Hypoglycemia Perinatal Care Diabetes In Pregnancy

ClinConnect Summary

This clinical trial is exploring whether automated insulin delivery (AID) systems can help manage blood sugar levels during labor and delivery for pregnant individuals with type 1 diabetes (T1D). The researchers want to find out if using AID systems leads to better blood sugar control for newborns, improves satisfaction with the birth experience, and results in more time spent within the target blood sugar range compared to the traditional method of using intravenous (IV) insulin.

To participate in this study, you must be a pregnant person with a known diagnosis of type 1 diabetes for at least a year, currently using an AID system for at least six months, and at least 34 weeks along in your pregnancy. The study is not open for recruitment yet, and those who are eligible will be randomly assigned to either use the AID system or the standard IV insulin during labor. It's important to know that certain conditions, like planned cesarean deliveries or specific medications, may exclude you from participating.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Known diagnosis of type 1 diabetes ≥ 1 year
  • Current use of commercially available AID system ≥ 6 months
  • Currently pregnant at ≥ 34 weeks
  • Singleton pregnancy
  • English- or Spanish-speaking
  • Exclusion Criteria:
  • Planned cesarean delivery
  • Use of medications known to interfere with glucose metabolism
  • Intrauterine fetal demise
  • Physical or psychological disease likely to interfere with the conduct of the study and/or the ability to participate in own healthcare

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

San Francisco, California, United States

Patients applied

0 patients applied

Trial Officials

Ivonne Verduzco, MD

Principal Investigator

University of California, San Francisco

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported