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Commercial or Open Source Closed Loop Impact on Pregnancy Study

NCT06654713 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-05-07

No results posted yet for this study

Summary

The goal of this observational study is to better understand what happens when pregnant people with type 1 diabetes (T1D) use automated insulin delivery (AID) systems. The main questions this study aims to answer are:

* What are the maternal and neonatal outcomes with AID system use in pregnancy?
* What are the glycemic outcomes with AID system use in pregnancy?
* What are the behavioral and emotional outcomes with AID system use in pregnancy?

Researchers will compare pregnant people who use commercial AID systems and pregnant people who use open source AID systems to see if outcomes are different with these different types of systems.

Participants will be asked to remotely share their AID system data with the research team; complete online surveys regarding behavioral and emotional health; and sign an authorization to release health information to allow the research team to access medical records.

Conditions

  • Type 1 Diabetes
  • Pregnancy, High Risk
  • Insulin Dependent Diabetes
  • Pregnancy Related

Interventions

OTHER

Commercial AID system

AID system that is commercially available and FDA approved for use

OTHER

Open source AID system

AID system that uses unregulated open-source software to customize an insulin delivery algorithm to connect an insulin pump to a continuous glucose monitor

Sponsors & Collaborators

Principal Investigators

  • Nasim Sobhani, MD · University of California, San Francisco

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654713 on ClinicalTrials.gov