Health Trials

About this trial

The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D). The main questions this study aims to answer are

* What are the neonatal glycemic outcomes with use of AID systems during labor/delivery? * Do patients report higher birth satisfaction with use of AID systems during labor/delivery? * Are glycemic parameters like time-in-range (TIR) better with use of AID systems during labor/delivery?

Researchers will compare AID systems to intravenous (IV) insulin (the current standard of care for glucose management during labor/delivery) by randomly assigning participants to one or the other.

Eligibility criteria

Qualifiers

Currently pregnant at ≥ 34 weeks

Known diagnosis of type 1 diabetes ≥ 1 year

Use of commercially available AID system since at least 28 weeks gestation

Singleton pregnancy

Disqualifiers

Multifetal gestation

Planned cesarean delivery

Use of medications known to interfere with glucose metabolism

Intrauterine fetal demise

Trial design

Treatments tested in this trial

  • Automated insulin delivery (AID) system
  • Intravenous (IV) insulin

Treatment groups

150 Participants
are divided into 2 treatment groups

Locations

3
University of California, Los Angeles90095, Los AngelesCalifornia, United States
University of California, San Diego92121, San DiegoCalifornia, United States
University of California, San Francisco94143, San FranciscoCalifornia, United States

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

Source ClinicalTrials.gov