Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Pregnant

Diagnosis of type 1 diabetes (T1D) prior to pregnancy

Active use of automated insulin delivery (AID) system

Disqualifiers

Diagnosis of other forms of diabetes (gestational diabetes, type 2 diabetes, monogenic diabetes)

Trial design

Treatments tested in this trial

  • Commercial AID system
  • Open source AID system

Treatment groups

1,000 Participants
are divided into 2 treatment groups

Locations

1
University of California, San Francisco94158, San FranciscoCalifornia, United States

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov