Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
- Conditions
- Diabetes MellitusPregnancy Complications
- Interventions
- Drug: Control (insulin Novorapid)
- Registration Number
- NCT03770767
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
A randomised controlled, open-label trial in an unselected cohort of pregnant women with type 1 or type 2 diabetes allocated to insulin Fiasp® or insulin NovoRapid® during pregnancy and lactation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention with insulin Fiasp Faster-acting Aspart insulin Fiasp Women randomized to insulin Fiasp Control (insulin Novorapid) Control (insulin Novorapid) Women randomized to insulin NovoRapid
- Primary Outcome Measures
Name Time Method Birth weight standard deviation score At delivery Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender
- Secondary Outcome Measures
Name Time Method Pregnancy complications and outcomes 9 months The prevalence of miscarriage, mode of delivery, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death
Fetal overgrowth At birth The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or \>90th percentile
Preprandial self-monitoring of plasma glucose (SMPG) levels 9 months Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
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 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.
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 Maternal weight in pregnancy and 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 HbA1c levels in pregnancy, one and three months after delivery
Infant weight 3 months Infant weight during the first 3 months of life
Mild hypoglycaemia 12 months The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth.
Postprandial self-monitoring of plasma glucose (SMPG) levels 9 months Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
Continuous glucose monitoring data 9 months 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.
Severe hypoglycemia 2 years The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth
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 Neonatal morbidity
Trial Locations
- Locations (1)
Center for Pregnant Women with Diabetes, Rigshospitalet
🇩🇰Copenhagen, Denmark