Clinical Trial

National Trial of CGM in Pregnant Women With Type 2 Diabetes

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Summary
The goal of this clinical trial is to evaluate the use of glucose sensors in pregnant women with type 2 diabetes to improve insulin regulation, pregnancy and birth outcomes, and enhance quality of life and satisfaction with treatment. The main questions it aims to answer are: * Does the use of glucose sensors during pregnancy lead to a clinically significant reduction in HbA1c by 0.3% at 36 weeks gestation compared to the control group? * Does the use of glucose sensors during pregnancy result in a clinically significant reduction in mean SD-score for birth weight deviation in newborns compared to the control group? Researchers will compare the group of women using glucose sensors during pregnancy to a historical control group receiving routine care to see if the sensor improves pregnancy outcomes, glucose control, and birth weights. Participants will: * Use a glucose sensor from before 14 weeks of pregnancy until 4-6 weeks postpartum. * Receive training on how to use the sensor and access ongoing support as needed. * Have a follow-up appointment 4-6 weeks postpartum, including a consultation for advice on medical treatment and further management of diabetes after birth.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-25.
Trial Details
NCT Number NCT06903728
Lead Sponsor Odense University Hospital
Collaborators: Steno Diabetes Center Odense, Steno Diabetes Center Copenhagen, Aarhus University Hospital, Steno Diabetes Center Nordjylland
Conditions Type 2 Diabetes, Pregnancy
Enrollment 200 participants
Start Date 2026-03
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-31