Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention with insulin Fiasp Women randomized to insulin Fiasp |
Drug: Faster-acting Aspart insulin Fiasp
Randomization to treatment with insulin Fiasp
Other Names:
|
| Active Comparator: Control (insulin Novorapid) Women randomized to insulin NovoRapid |
Drug: Control (insulin Novorapid)
Randomization to standard treatment with insulin Novorapid
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Birth weight standard deviation score [At delivery]
Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender
Secondary Outcome Measures
- 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
- Postprandial self-monitoring of plasma glucose (SMPG) levels [9 months]
Postprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy
- 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.
- 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
- Mild hypoglycaemia [12 months]
The incidence of mild hypoglycemia during pregnancy and the first three months after giving 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]
Maternal weight in pregnancy and after delivery
- 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
- Infant weight [3 months]
Infant weight during the first 3 months of life
- 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
Eligibility Criteria
Criteria
Inclusion criteria
-
Women, age ≥ 18 years
-
Duration of type 1 diabetes (or mature onset of diabetes in the young) ≥ 12 months
-
Type 2 diabetes (any duration)
-
Pregnant with an intrauterine singleton living fetus confirmed by an ultrasound scan between 8+0 and 13+6 gestational weeks
-
Routine use of insulin pump therapy, insulin detemir, insulin degludec, insulin glargine, insulin abasaglar, insulin toujeo or Neutral Protamine Hagedorn insulin and willing to continue routine treatment modality
-
Women with type 1 diabetes using an insulin pump compatible with trial products
-
Women with type 2 diabetes treated with diet, oral antidiabetic therapy or pre-mixed insulin before pregnancy and willing to change to trial medication according to randomization or to an appropriate long-acting insulin analogue, as indicated
-
Proficiency in Danish to understand oral and written information
Exclusion criteria
• Severe mental or psychiatric barriers or concurrent disease on the decision of the principal investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Pregnant Women with Diabetes, Rigshospitalet | Copenhagen | Denmark |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
- Principal Investigator: Lene Ringholm, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- U1111