Diabetes Mellitus Clinical Trial
— ETOS-DMOfficial title:
A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in Women With Diabetes Mellitus
NCT number | NCT06250192 |
Other study ID # | 12345 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2023 |
Est. completion date | June 1, 2026 |
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 ij women with pre-existing diabetes mellitus compared to women receiving usual individual face-to-face education alone.
Status | Recruiting |
Enrollment | 502 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Women, age = 18 years - Type 1 diabetes, type 2 diabetes or other types of pre-existing diabetes (e.g., maturity onset diabetes of the young (MODY)) - Pregnant with one or more intrauterine singleton living foetus(es) (5 to 13 completed gestational weeks) at inclusion confirmed by an ultrasound scan) Exclusion Criteria: - A diagnosis with severe mental or psychiatric barriers or a concurrent disease based on the decision of the investigator - No proficiency in Danish to understand oral and written information To secure independent observations, women can be randomized in the ETOS-DM study only once. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Pregnant Women with Diabetes | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Birthweight standard deviation score | Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score) | At delivery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Fetal overgrowth | The prevalence of fetal overgrowth, defined as the offspring birth weight SD score >90th percentile | At birth | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Major congenital malformations | Number of major congenital malformations (ICD10 Q00-Q99 or requiring medical or surgical treatment) | 9 months | |
Secondary | Infant growth at one month of age | Infant growth and health at one month of age | 1 month | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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 |
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