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Search / Trial NCT06654713

Commercial or Open Source Closed Loop Impact on Pregnancy Study

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Oct 21, 2024

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, called the Commercial or Open Source Closed Loop Impact on Pregnancy Study, is looking at how automated insulin delivery (AID) systems affect pregnant people who have type 1 diabetes (T1D). The researchers want to learn more about the outcomes for both mothers and their babies, how well blood sugar levels are managed, and the emotional and behavioral experiences of those using these systems during pregnancy. They will compare two types of AID systems: commercial systems that are sold by companies and open-source systems that are developed by users.

To participate, you need to be pregnant, have been diagnosed with type 1 diabetes before becoming pregnant, and actively use an AID system. Unfortunately, those with other types of diabetes, such as gestational or type 2 diabetes, are not eligible for this study. If you join, you will share information from your AID system with the research team, complete online surveys about your emotional well-being, and allow the team to access your medical records. This study is currently recruiting participants, and it aims to provide valuable insights into how these systems can support pregnant individuals with diabetes.

Gender

FEMALE

Eligibility 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)

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

Nasim Sobhani, MD

Principal Investigator

University of California, San Francisco

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported