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Completed

NCT Number: NCT06250192

Educational TOolS for Pregnant Women With Diabetes Mellitus

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Pregnant Women with Diabetes

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

Video-based education

Other

Randomization to video-based education delivered via a smartphone app in addition to usual care

Primary outcomes

  1. Birthweight standard deviation score

    Time frame: At delivery

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

Secondary outcomes

  1. HbA1c during pregnancy

    Time frame: At inclusion, at 21 weeks, at 33 weeks and at 35 weeks

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

  2. Continuous glucose monitoring data

    Time frame: Throughout pregnancy and 1 month post delivery

    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

  3. Severe hypoglycemia

    Time frame: 2 years

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

  4. Maternal weight gain

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

    Maternal gestational weight gain and weight retention one month after delivery

  5. Individuel insulin pump settings in women using insulin pump

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

    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

  6. Fetal overgrowth

    Time frame: At birth

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

  7. Pregnancy complications

    Time frame: 9 months

    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

  8. Prevalence of birth complications

    Time frame: At birth and one month post delivery

    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

  9. Prevalence of neonatal morbidity

    Time frame: 1 month

    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

  10. Major congenital malformations

    Time frame: 9 months

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

  11. Infant growth at one month of age

    Time frame: 1 month

    Infant growth and health at one month of age

  12. Maternal reported outcomes during pregnancy and one month postpartum

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

    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).

  13. Partner reported outcomes during pregnancy and one month postpartum

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

    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).

  14. Continuous glucose monitoring metrics 1 months post delivery

    Time frame: 1 months

    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.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in Women With Diabetes Mellitus

Acronym: ETOS-DM

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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