Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes

HbA1c levels

HbA1c levels in pregnancy, one and three months after delivery

Time frame: 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

Postprandial self-monitoring of plasma glucose (SMPG) levels

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

Time frame: 9 months

Preprandial self-monitoring of plasma glucose (SMPG) levels

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

Time frame: 9 months

Insulin treatment and dose (IU) including insulin pump settings

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.

Time frame: 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

Continuous glucose monitoring data

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.