Virtual education tool for pregnant women with diabetes
A Randomized Controlled Trial Evaluating the Effect of Virtual Patient-centered Education on Infant Birthweight in Women With Diabetes Mellitus
NA · Odense University Hospital · NCT06250192
This study tests whether a virtual education tool can help pregnant women with diabetes manage their condition better than just the usual face-to-face education.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 502 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Odense University Hospital (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06250192 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a patient-centered virtual educational tool that includes short videos on mental health, diet, physical activity, insulin management, and diabetes technology for pregnant women with pre-existing diabetes. Participants will be randomized to receive either this virtual education in addition to standard face-to-face education or standard education alone. The study aims to improve glycemic control and pregnancy outcomes by providing accessible educational resources. Women will be monitored throughout their pregnancy and up to one month postpartum.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older with pre-existing diabetes, including type 1, type 2, or other forms of diabetes.
Not a fit: Patients with severe mental health issues or those who cannot understand Danish may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance glycemic control and improve pregnancy outcomes for women with diabetes.
How similar studies have performed: Other studies have shown promise in using virtual education tools for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen
- Center for Pregnant Women with Diabetes — Copenhagen, Denmark (RECRUITING)
Study contacts
- Principal investigator: Elisabeth Mathiesen — Rigshospitalet, Denmark
- Study coordinator: Elisabeth Mathiesen
- Email: Elisabeth.reinhardt.mathiesen@regionh.dk
- Phone: +4528948819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Pregnancy Complications