임상시험 레이더

Birthweight standard deviation score

Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score)

At delivery

HbA1c during pregnancy

HbA1c levels during pregnancy at inclusion, 21, 33 and 35 weeks

At inclusion, at 21 weeks, at 33 weeks and at 35 weeks

Continuous glucose monitoring data

The average glucose level and percentage of time spent in the continuous glucose monitoring (CGM) target range 3.5-7.8 mmol/L, below target range (glucose \<3.5 mmol/L) or above target range (glucose \>7.8 mmol/L). The levels will be evaluated at night-time (24 pm to 6 am) and over 24 h, respectively, in pregnancy, during delivery and in the first one-month period after delivery. • The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and in the first one-month period after delivery

Throughout pregnancy and 1 month post delivery

Severe hypoglycemia

The incidence of severe hypoglycemia in the year preceding pregnancy, during pregnancy and in the first one-month period after delivery

2 years

Maternal weight gain

Maternal gestational weight gain and weight retention one month after delivery

At inclusion, at 21 weeks, at 33 weeks, 35 weeks and one month after delivery

Individuel insulin pump settings in women using insulin pump

In women using insulin pump the following will be collected: insulin pump settings at study visits, at delivery andthe first month after delivery during lactation

At inclusion, at 21 weeks, at 33 weeks, 35 weeks, at delivery and one month after delivery

Fetal overgrowth

The prevalence of fetal overgrowth, defined as the offspring birth weight SD score \>90th percentile

At birth

Pregnancy complications

The prevalence of induced abortion (including indication for abortion), miscarriage, gestational hypertension, preeclampsia, need for maternal corticosteroid treatment for fetal lung maturation, diabetic ketoacidosis, urinary tract infection, early preterm delivery (before 34 completed weeks), preterm delivery (before 37 completed weeks), preterm prelabour rupture of the membranes

9 months

Prevalence of birth complications

The prevalence of shoulder dystocia, birth canal trauma, mode of delivery (vaginal, cesarean section, instrumental delivery), postpartum hemorrhage, maternal death, antihypertensive treatment given one month after delivery

At birth and one month post delivery

Prevalence of neonatal morbidity

Neonatal morbidity (neonatal hypoglycemia, 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

1 month

Major congenital malformations

Number of major congenital malformations (ICD10 Q00-Q99 or requiring medical or surgical treatment)

9 months

Infant growth at one month of age

Infant growth and health at one month of age

1 month

Maternal reported outcomes during pregnancy and one month postpartum

Maternal reported outcomes, including measures assessing health status (SF-12), depression (EPDS), well-being (WHO-5), pregnancy-specific worries (CWS), perceived stress (PSS), loneliness (T-ILS), diabetes related distress (PAID), fear of hypoglycaemia (HFS-II worry scale), satisfaction with care (PACIC), psychopathology developing during pregnancy and pre-natal attachment (MAAS).

In early pregnancy, in late pregnancy and one month post-partum.

Partner reported outcomes during pregnancy and one month postpartum

Partner reported outcomes, including measures assessing health status (SF-12), depression (EPDS), well-being (WHO-5), pregnancy-specific worries (CWS), perceived stress (PSS), loneliness (T-ILS), diabetes related distress (PAID), fear of hypoglycaemia (HFS-II worry scale), satisfaction with care (PACIC), psychopathology developing during pregnancy and pre-natal attachment (MAAS).

In early pregnancy, in late pregnancy and one month post-partum.

Continuous glucose monitoring metrics 1 months post delivery

Average glucose level and the percentage of time in the first one-month period after delivery spent in the CGM target range 3.9-10.0 mmol/L, below target range (glucose \<3.5 mmol/L) or above target range (glucose \>7.8 mmol/L) at night-time (24 pm to 6 am) and over 24 h, respectively.

1 months