Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes

This multicenter, randomized controlled trial evaluated the efficacy of hybrid closed loop insulin therapy in pregnant women with type 1 diabetes. Participants (n=124) were assigned to either hybrid closed loop therapy (CamAPS FX system) or standard insulin therapy with continuous glucose monitoring. The primary outcome was the percentage of time spent in the pregnancy-specific target glucose range (63–140 mg/dL) from 16 weeks’ gestation until delivery. The closed loop group achieved significantly more time in the target range (68.2% vs. 55.6%; adjusted difference: 10.5 percentage points, 95% CI: 7.0–14.0, P<0.001), with reduced hyperglycemia and improved overnight glycemic control. Glycated hemoglobin levels were lower in the closed-loop group, and severe hypoglycemia events were rare (6 vs. 5 in standard care). Neonatal outcomes were comparable, though preterm births were more frequent in the closed-loop group (45% vs. 22%). The study demonstrates that hybrid closed loop therapy significantly improves maternal glycemic control during pregnancy without increasing adverse events.

This multicenter, randomized controlled trial evaluated the efficacy of hybrid closed loop insulin therapy in pregnant women with type 1 diabetes. Participants (n=124) were assigned to either hybrid closed loop therapy (CamAPS FX system) or standard insulin therapy with continuous glucose monitoring. The primary outcome was the percentage of time spent in the pregnancy-specific target glucose range (63–140 mg/dL) from 16 weeks’ gestation until delivery. The closed loop group achieved significantly more time in the target range (68.2% vs. 55.6%; adjusted difference: 10.5 percentage points, 95% CI: 7.0–14.0, P<0.001), with reduced hyperglycemia and improved overnight glycemic control. Glycated hemoglobin levels were lower in the closed-loop group, and severe hypoglycemia events were rare (6 vs. 5 in standard care). Neonatal outcomes were comparable, though preterm births were more frequent in the closed-loop group (45% vs. 22%). The study demonstrates that hybrid closed loop therapy significantly improves maternal glycemic control during pregnancy without increasing adverse events.