Effects of Commercial and Open Source Automated Insulin Delivery Systems During Pregnancy in People with Type 1 Diabetes

What this Trial Is About

Researchers are studying pregnant people with type 1 diabetes T1D who use automated insulin delivery AID systems to better understand maternal, neonatal, glycemic, behavioral, and emotional outcomes during pregnancy. This observational study compares outcomes between those using commercially available, FDA-approved AID systems and those using open source AID systems with custom software. The goal is to see if different types of AID systems affect pregnancy and health results. Participants are divided into two groups based on the type of AID system they use commercial systems and open source systems. Both groups will continue managing their diabetes with their respective AID systems as usual. There is no treatment assignment, as this is an observational study focusing on real-world use of these devices throughout pregnancy and postpartum. Participants will share their AID system data remotely with the research team, complete online surveys about behavioral and emotional health, and authorize access to their medical records. The study measures outcomes such as baby size at birth, hypertension disorders during pregnancy, diabetes-related distress, and time spent in target glucose ranges from enrollment through 8 weeks after delivery. Neonatal complications and other health events are also tracked up to 28 days after birth. The study duration extends through pregnancy and postpartum monitoring.

Commercial or Open Source Closed Loop Impact on Pregnancy Study