A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.
This is a national multi-center open-label randomized controlled trial investigating whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy (\<14 completed weeks) improves maternal glycemic control in women with type 1 diabetes during pregnancy, delivery and post-delivery and leads to more appropriate fetal growth compared to usual insulin treatment modality (multiple day injections or insulin pump) combined with continuous glucose monitoring. Women planning pregnancy will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring, as per randomisation allocation before conception and throughout pregnancy until one month post-delivery or for up to 52 weeks if not becoming pregnant. Women who become pregnant during the 52-week study period will be referred to their local center for pregnant women with diabetes and followed during pregnancy until one month post-delivery. Women who do not become pregnant during the 52-week study period will leave the study and continue usual diabetes care at their usual diabetes center. Women who are pregnant at randomisation will initiate the automated insulin delivery system CamAPS FX or continue usual insulin treatment modality combined with a compatible continuous glucose monitoring as per randomisation allocation, throughout the pregnancy period until one month post-delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
305
Automated closed-loop insulin delivery and The mylife CamAPS FX algorithm combined with CGM
Department of Gynecology and Obstetrics, Aalborg University Hospital
Aalborg, Aalborg, Denmark
RECRUITINGDepartment of Gynecology and Obstetrics, Aarhus University Hospital
Aarhus, Aarhus N, Denmark
RECRUITINGSteno Diabetes Center Aarhus
Aarhus, Aarhus N, Denmark
RECRUITINGSteno Diabetes Center Nordjylland
Aalborg, Gistrup, Denmark
RECRUITINGSteno Diabetes Center Copenhagen
Copenhagen, Herlev, Denmark
RECRUITINGDepartment of Gynecology and Obstetrics, Odense University Hospital
Odense, Odense C, Denmark
RECRUITINGSteno Diabetes Center Odense, Odense University Hospital
Odense, Odense C, Denmark
RECRUITINGCenter for Pregnant Women with Diabetes, Rigshospitalet
Copenhagen, Denmark
RECRUITINGTime in range
The between group difference in time in range in pregnancy (3.5-7.8 mmol/L) between intervention and controls
Time frame: From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.
Neonatal outcome: Birthweight
Offspring birthweight standard deviation score adjusted for gestational age and infant gender.
Time frame: At delivery
Continuous glucose monitoring data
Mean sensor glucose, mean sensor glucose coefficient of variation, time in range in pregnancy 3.5-7.8 mmol/l, time above range in pregnancy \>7.8 mmol/l and time below range in pregnancy \<3.5 mmol/l between intervention and controls
Time frame: From randomisation during pregnancy planning until delivery or leaving study after 52 weeks (randomized during pregnancy planning) or from randomization in early pregnancy to delivery
Insulin and carbohydrates
Total daily insulin dose, percentage insulin administered as basal insulin, carbohydrate-to-insulin ratio, numbers of boluses (automatic and manual), daily amount of entered carbohydrates
Time frame: Randomization, during pregnancy planning, study visits during pregnancy, around delivery and at one month post-delivery
System features
* Use of specific features as auto mode, "Ease-off" and "Boost" functions (intervention group) * Use of specific features as auto mode, night mode, fake carbohydrates (women in the control group using AID systems other than the CamAPS FX system)
Time frame: From inclusion until one month post-delivery
HbA1c
HbA1c before pregnancy and HbA1c levels during pregnancy.
Time frame: Inclusion, last before pregnancy, at 9, 21, 33 and 35 weeks
Severe hypoglycemia
The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and in the first one-month period post-delivery
Time frame: 2 years - if not becoming pregnant in the study period - until leaving the study
Ketoacidosis
The prevalence of diabetic ketoacidosis (positive ketones in urine or serum, pH ≤7·30 and/or bicarbonate ≤18 mmol/l)
Time frame: During pregnancy planning OR during pregnancy and post-delivery
Weight
Maternal gestational weight gain and weight retention one month post-delivery OR Weight at randomization and last weight before pregnancy
Time frame: At inclusion until one month post-delivery OR leaving the study
Fetal overgrowth
The prevalence of fetal overgrowth, defined as the offspring birth weight standard deviation score \>90th percentile
Time frame: At birth
Pregnancy complications
Prevalence of induced abortion, miscarriage, gestational hypertension, preeclampsia, need for maternal corticosteroid treatment for fetal lung maturation, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preterm pre-labour rupture of the membranes
Time frame: 9 months
Birth complications
Prevalence of shoulder dystocia, birth canal trauma, mode of delivery (vaginal delivery, instrumental delivery, planned cesarean section, emergency cesarean section), postpartum hemorrhage, maternal death
Time frame: From delivery until one month post-delivery
Neonatal morbidity
Neonatal hypoglycemia with plasma glucose \<2.2 mmol/l two hours after birth, neonatal hypoglycemia requiring treatment with intravenous glucose, jaundice, respiratory distress, transient tachypnoea, duration of stay in neonatal intensive care unit, total number of admission days, cord blood pH, stillbirths, infant death within one month post-delivery
Time frame: At delivery until one month post-delivery
Major congenital malformations
ICD10 Q00-Q99 or requiring medical or surgical treatment
Time frame: From delivery until one month post-delivery
Infant growth
Evaluated by weight standard deviation score and health evaluated as days with hospitalization during the first month of life after discharge in the neonatal period
Time frame: One month post-delivery
Lactation
The prevalence of lactation
Time frame: One month post-delivery
Lene Ringholm Chief physician, PhD, Associate Professor
CONTACT
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