Clinical trial NCT06250192: Educational TOolS for Pregnant Women With Diabetes Mellitus.
Official title: A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in Women With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Pregnancy Complications
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 502
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Birthweight standard deviation score
timeFrame: At delivery
Secondary outcomes:
measure: HbA1c during pregnancy
timeFrame: At inclusion, at 21 weeks, at 33 weeks and at 35 weeks
measure: Continuous glucose monitoring data
timeFrame: Throughout pregnancy and 1 month post delivery
measure: Severe hypoglycemia
timeFrame: 2 years
measure: Maternal weight gain
timeFrame: At inclusion, at 21 weeks, at 33 weeks, 35 weeks and one month after delivery
measure: Individuel insulin pump settings in women using insulin pump
timeFrame: At inclusion, at 21 weeks, at 33 weeks, 35 weeks, at delivery and one month after delivery
measure: Fetal overgrowth
timeFrame: At birth
measure: Pregnancy complications
timeFrame: 9 months
measure: Prevalence of birth complications
timeFrame: At birth and one month post delivery
measure: Prevalence of neonatal morbidity
timeFrame: 1 month
measure: Major congenital malformations
timeFrame: 9 months
measure: Infant growth at one month of age
timeFrame: 1 month
measure: Maternal reported outcomes during pregnancy and one month postpartum
timeFrame: In early pregnancy, in late pregnancy and one month post-partum.
measure: Partner reported outcomes during pregnancy and one month postpartum
timeFrame: In early pregnancy, in late pregnancy and one month post-partum.
measure: Continuous glucose monitoring metrics 1 months post delivery
timeFrame: 1 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Pregnant Women with Diabetes
Study officials:
affiliation: Rigshospitalet, Denmark
name: Elisabeth Mathiesen
role: PRINCIPAL_INVESTIGATOR
References: