NCT06903728

National Trial of CGM in Pregnant Women With Type 2 Diabetes

National forsøgsordning Med Glukosesensorer Til Type 2-diabetes: Glukosesensorer Til Gravide Med Type 2-diabetes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes
• Pregnancy

Interventions

Type	Name	Description
DEVICE	continous glucose monitoring	Pregnant women with type 2 diabetes are given a sensor \< week 14 of their pregnancy and will use it until 4-6 post partum. They will receive training in how to use the sensor, and support when needed.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-04-01
• Last updated: 2025-07-31

Regulatory

• FDA-regulated device study