A randomized controlled trial evaluating whether a patient-centered virtual educational tool based on small videos focusing on optimization of mental health, diet, physical activity, self-adjustment of insulin dose and use of diabetes technology in addition to usual individual face-to-face education, will improve glycemic control and pregnancy outcome in women with pre-existing diabetes mellitus compared to women receiving usual individual face-to-face education alone.
ETOS-DM is a national RCT evaluating the effect of combined virtual patient-centered education based on a tool of small videos accessible via smartphones in addition to usual individual face-to-face education during pregnancy or to routine individual face-to-face education only. The small educational videos covering topics as food choices, physical activity, self-adjustment of insulin dose insulin pump settings during pregnancy, use of CGM during pregnancy, mental health among others,each of 1-4 minutes duration, will be developed in collaboration with user representatives (women with pre-existing diabetes who are or have recently been pregnant) and relevant health care professionals. The inclusion period of the ETOS-DM study starts on September 1st 2023 and ends on August 31st 2025. Pregnant women with pre-existing diabetes will be randomized before 14 gestational weeks. The women in the intervention group will have free, unlimited access to approximately 10 educational videos. The use of these virtual educational videos will be monitored and the women's own experience with the videos will be explored. The women will be followed during pregnancy, delivery until one month after delivery. Both groups of women follow usual local care and local face-to-face education which is allowed to change during the study period. Stratification will be performed for diabetes center, for diabetes type and, in women with type 1 diabetes, use of MDI or insulin pump.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
502
Randomization to virtuel education based on a tool of small videos accessible via smartphones
Center for Pregnant Women with Diabetes
Copenhagen, Denmark
Birthweight standard deviation score
Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score)
Time frame: At delivery
HbA1c during pregnancy
HbA1c levels during pregnancy at inclusion, 21, 33 and 35 weeks
Time frame: 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
Time frame: 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
Time frame: 2 years
Maternal weight gain
Maternal gestational weight gain and weight retention one month after delivery
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 month
Major congenital malformations
Number of major congenital malformations (ICD10 Q00-Q99 or requiring medical or surgical treatment)
Time frame: 9 months
Infant growth at one month of age
Infant growth and health at one month of age
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 1 months