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Clinical Trial Details

Trial ID: L2824
Source ID: NCT03770767
Associated Drug: Faster-Acting Aspart Insulin Fiasp
Title: Insulin Fiasp vs. Insulin Novorapid During Pregnancy and Laction in Women With Pre-existing Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Pregnancy Complications
Interventions: DRUG: Faster-acting Aspart insulin Fiasp|DRUG: Control (insulin Novorapid)
Outcome Measures: Primary: Birth weight standard deviation score, Offspring birth weight (measured as standard deviation score) adjusted for gestational age and gender, At delivery | Secondary: HbA1c levels, HbA1c levels in pregnancy, one and three months after delivery, 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, 9 months|Preprandial self-monitoring of plasma glucose (SMPG) levels, Preprandial self-monitoring of plasma glucose (SMPG) levels in pregnancy, 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., 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., 9 months|Severe hypoglycemia, The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and the first three months after giving birth, 2 years|Mild hypoglycaemia, The incidence of mild hypoglycemia during pregnancy and the first three months after giving birth., 12 months|Maternal weight, Maternal weight in pregnancy and after delivery, 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|Pregnancy complications and outcomes, The prevalence of miscarriage, mode of delivery, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preeclampsia and perinatal death, 9 months|Fetal overgrowth, The prevalence of fetal overgrowth, defined as the offspring birth weight SD score +1.28 or \>90th percentile, At birth|Infant weight, Infant weight during the first 3 months of life, 3 months|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), Neonatal morbidity, 3 months
Sponsor/Collaborators: Sponsor: Rigshospitalet, Denmark
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 216
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-11-11
Completion Date: 2023-03-23
Results First Posted:
Last Update Posted: 2023-05-06
Locations: Center for Pregnant Women with Diabetes, Rigshospitalet, Copenhagen, Denmark
URL: https://clinicaltrials.gov/show/NCT03770767