Study Comparing Automated Insulin Delivery With Usual Insulin Treatment Before and During Pregnancy in Women With Type 1 Diabetes

What this Trial Is About

Researchers are conducting a national multi-center open-label randomized controlled trial to evaluate if using the automated insulin delivery system CamAPS FX, started before or early in pregnancy, improves blood sugar control and fetal growth for women with type 1 diabetes compared to usual insulin treatments combined with continuous glucose monitoring. The study focuses on maternal glycemic targets during pregnancy, delivery, and post-delivery, assessing if this system leads to better outcomes for both mother and baby. Participants include women planning pregnancy who will either begin using CamAPS FX or continue their usual insulin treatment and compatible glucose monitoring for up to 52 weeks or until one month after delivery if they become pregnant. Women already pregnant at randomization will start CamAPS FX or continue usual treatment until one month post-delivery. Women not becoming pregnant during the study will leave and return to usual diabetes care. Participants will be monitored throughout with continuous glucose data, insulin and carbohydrate intake, HbA1c levels, and fetal growth measurements. Outcomes include time spent in target blood sugar range, birthweight, pregnancy and birth complications, and neonatal health up to one month after delivery. Safety events like severe hypoglycemia and ketoacidosis are also tracked, with follow-up continuing until one month post-delivery or up to two years if pregnancy does not occur within the study period.

Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes