Educational TOolS for Pregnant Women With Diabetes Mellitus

NCT ID: NCT06250192

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-06-01

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.

Conditions

Diabetes Mellitus; Pregnancy Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention with patient-centered virtuel educational tools

Patient randomized to intervention with patient-centered virtuel educational tools based on small videos

Group Type: EXPERIMENTAL

Virtuel education

Intervention Type: OTHER

Randomization to virtuel education based on a tool of small videos accessible via smartphones

Control: Women were randomized to usal care

Randomized to standard treatment without acces to virutel educational tools

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtuel education

Randomization to virtuel education based on a tool of small videos accessible via smartphones

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Mathiesen

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Center for Pregnant Women with Diabetes

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

12345

Identifier Type: -

Identifier Source: org_study_id