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NCT06903728Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
25 Mar 2025
Start date
Mar 2026
Primary completion date
Dec 2026
Lead sponsor
Odense University Hospital
NCT number
NCT06903728

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From Mar 2026 to the primary completion date, Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • already using a continous glucose monitor (sensor)

Age

  • gestationel age 14+0 or above

Other

  • ekspected birth after end of trial

Who the study is looking for

  • pregnant women with type 2 diabetes
  • attending one of the four centers for pregnancy and diabetes in Denmark
  • 18 years old or above

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.