Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-28 @ 8:24 AM
Study NCT ID:
NCT06250192
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational TOolS for Pregnant Women With Diabetes Mellitus
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in Women With Diabetes Mellitus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETOS-DM
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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: