Randomization to standard treatment with insulin Novorapid

Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy

Type of insulin, dose (IU) during pregnancy, around delivery and until 3 months after delivery. In women on insulin pump therapy: appropriate insulin pump dosing (IU) during pregnancy, around delivery and until 3 months after delivery.

The amount of time during CGM use spent in the target range 3.5-7.8 mmol/l, with glucose <3.5 mmol/L and glucose >7.8 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively, in pregnancy and around delivery (in the morning for induction of labour or planned caesarean section). • The percentage of time during the first one-week period after delivery spent in the target range 3.9-10.0 mmol/L, with glucose <3.9 mmol/L and glucose >10.0 mmol/L at night-time (23 pm to 7 am) and over 24 h, respectively.

The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth

The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.

Maternal weight in pregnancy and after delivery

The prevalence of miscarriage, mode of delivery, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death

The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or >90th percentile

Infant weight during the first 3 months of life

Neonatal morbidity