Educational TOolS for Pregnant Women With Diabetes Mellitus

NCT06250192 | Active Not Recruiting

• 1 other identifier: 12345
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Birthweight standard deviation score

  Offspring birth weight adjusted for gestational age and gender (standard deviation (SD) score)

  At delivery

Secondary Outcomes (14)

• HbA1c during pregnancy

  At inclusion, at 21 weeks, at 33 weeks and at 35 weeks

• Continuous glucose monitoring data

  Throughout pregnancy and 1 month post delivery

• Severe hypoglycemia

  2 years

• Maternal weight gain

  At inclusion, at 21 weeks, at 33 weeks, 35 weeks and one month after delivery

• Individuel insulin pump settings in women using insulin pump

  At inclusion, at 21 weeks, at 33 weeks, 35 weeks, at delivery and one month after delivery

Study Arms (2)

Intervention with patient-centered virtuel educational tools

EXPERIMENTAL

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

Other: Virtuel education

Control: Women were randomized to usal care

NO INTERVENTION

Randomized to standard treatment without acces to virutel educational tools

Interventions

Virtuel education OTHER

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

Intervention with patient-centered virtuel educational tools

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Center for Pregnant Women with Diabetes

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus; Pregnancy Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Elisabeth Mathiesen

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 8, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)