A Randomised Controlled Trial Comparing the Effect of the Faster-acting Insulin Analog - Insulin Fiasp® - Versus Insulin Novorapid® in the Treatment of Women With Type 1 or Type 2 Diabetes During Pregnancy and Lactation. The Copen-fast Trial

简要总结

主要结局

次要结局

• Pregnancy complications and outcomes(9 months)
• Fetal overgrowth(At birth)
• Maternal weight(At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery)
• Preprandial self-monitoring of plasma glucose (SMPG) levels(9 months)
• Insulin treatment and dose (IU) including insulin pump settings(At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery)
• HbA1c levels(At inclusion in early pregnancy, at 21 weeks in pregnancy, at 33 weeks in pregnancy, at 36 weeks in pregnancy, at 1 month after delivery, at 3 months after delivery)
• Infant weight(3 months)
• Mild hypoglycaemia(12 months)
• Postprandial self-monitoring of plasma glucose (SMPG) levels(9 months)
• Continuous glucose monitoring data(9 months)
• Severe hypoglycemia(2 years)
• Neonatal morbidity (neonatal hypoglycaemia, jaundice, respiratory distress and duration of stay in neonatal intensive care unit) and infant morbidity evaluated as hospitalization during the first 3 months of life (after discharge in the neonatal period)(3 months)