Diabetes MellitusETOS-DMNCT06250192
Educational TOolS for Pregnant Women With Diabetes Mellitus
A study testing Video-based education in people with Diabetes Mellitus and Pregnancy Complications, run by Odense University Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Diabetes Mellitus, Pregnancy Complications
- What is being tested?
- Video-based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 621 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Pregnancy Complications
- Being tested
- Video-based education
- Medical subject headings
- Diabetes Mellitus, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-based educationOther
Randomization to video-based education delivered via a smartphone app in addition to usual care
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Randomized to usual care without acces to video-based education |
| Intervention | Experimental | Randomization to video-based education in addition to ussual care Receives: Other: Video-based education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birthweight standard deviation score
Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score)
Measured: At delivery
Secondary outcomes (14)
HbA1c during pregnancy
HbA1c levels during pregnancy at inclusion, 21, 33 and 35 weeks
Measured: 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
Measured: 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
Measured: 2 years
Maternal weight gain
Maternal gestational weight gain and weight retention one month after delivery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 month
Major congenital malformations
Number of major congenital malformations (ICD10 Q00-Q99 or requiring medical or surgical treatment)
Measured: 9 months
Infant growth at one month of age
Infant growth and health at one month of age
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Sep 2023
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Mathiesen, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250192
- Sponsor's protocol ID
- 12345
- Acronym
- ETOS-DM
- Status last verified
- Jun 2026
- First submitted
- 1 Feb 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in Women With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06250192
- Acronym / sponsor ID
- ETOS-DM / 12345
- Conditions
- Diabetes Mellitus, Pregnancy Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Randomized to usual care without acces to video-based education |
| Intervention | Experimental | Other: Video-based educationRandomization to video-based education in addition to ussual care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-based educationRandomization to video-based education delivered via a smartphone app in addition to usual care | Other | Intervention |
Primary outcome
Birthweight standard deviation score
Time frame: At delivery
Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score)
14 secondary outcomes
HbA1c during pregnancy
Time frame: At inclusion, at 21 weeks, at 33 weeks and at 35 weeks
Continuous glucose monitoring data
Time frame: Throughout pregnancy and 1 month post delivery
Severe hypoglycemia
Time frame: 2 years
Maternal weight gain
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
Time frame: At inclusion, at 21 weeks, at 33 weeks, 35 weeks, at delivery and one month after delivery
Fetal overgrowth
Time frame: At birth
Pregnancy complications
Time frame: 9 months
Prevalence of birth complications
Time frame: At birth and one month post delivery
Prevalence of neonatal morbidity
Time frame: 1 month
Major congenital malformations
Time frame: 9 months
Infant growth at one month of age
Time frame: 1 month
Maternal reported outcomes during pregnancy and one month postpartum
Time frame: In early pregnancy, in late pregnancy and one month post-partum.
Partner reported outcomes during pregnancy and one month postpartum
Time frame: In early pregnancy, in late pregnancy and one month post-partum.
Continuous glucose monitoring metrics 1 months post delivery
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Mathiesen principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-based education in people with Diabetes Mellitus and Pregnancy Complications, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birthweight standard deviation score (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.