A Phase 2 Open Label Randomized Trial Comparing Insulin Detemir and NPH in Pregnant Women with Type 2 and Gestational Diabetes

What this Trial Is About

Researchers are comparing the rates of neonatal hypoglycemia in pregnant women with type 2 diabetes or gestational diabetes using two types of long-acting insulin: insulin detemir and insulin NPH. This phase 2 randomized controlled trial explores how these insulins affect both mothers and newborns, aiming to improve diabetes management during pregnancy and reduce risks such as preeclampsia, preterm delivery, and neonatal complications. Insulin detemir is FDA-approved for type 1 diabetes in pregnancy and has a known safety profile, while insulin NPH is currently the only approved treatment for type 2 diabetes or gestational diabetes during pregnancy. Participants are randomly assigned to receive either insulin detemir or insulin NPH as their long-acting insulin to control blood sugar levels during pregnancy. The study is open-label, meaning both participants and researchers know which insulin is being used. The focus is on comparing the safety and effects of these two treatments during pregnancy through regular monitoring and follow-up. During the study, researchers will monitor newborns for hypoglycemia within the first 24 hours and beyond until hospital discharge. Additional assessments include measuring neonatal hormone levels, rates of pregnancy-induced hypertension, delivery mode, gestational age, maternal glycemic control, and infant health indicators up to one year after birth. Participants will undergo regular evaluations to track blood sugar control and any pregnancy or neonatal complications, with a total study duration that covers pregnancy and one year postpartum.

DETERMINE: Detemir vs NPH