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NCT Number: NCT06903728

National Trial of CGM in Pregnant Women With Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • gestationel age 14+0 or above
  • ekspected birth after end of trial
  • already using a continous glucose monitor (sensor)

Treatment and study plan

Continous Glucose Monitoring

Device

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.

Primary outcomes

  1. HbA1c at end of pregnancy (week 36 of pregnancy)

    Time frame: baseline < week 14 of pregnancy, follow up week 36 of pregnancy

  2. child birth weight SD-score

    Time frame: at time of birth

Secondary outcomes

  1. TIR, TAR, TBR

    Time frame: from enrollment to 4-6 weeks post partum

    Percentage of time in time in range, time above range and time below range during their pregnancy.

  2. Mean glucose

    Time frame: from enrollment to 4-6 weeks post partum

    Sensor specific data

  3. Womens gestational wheight gain

    Time frame: from enrollment to birth

    weight gain during throughout pregnancy

  4. Hypoglykemia among newborn

    Time frame: at time of birth

    Hypoglykemia among newborn

  5. Pregnancy related complications

    Time frame: from enrollment to birth

    increased blood pressure and preeclampsia

  6. Birth related complications

    Time frame: at time of birth

    c-section, early birth

  7. Problem Areas in Diabetes (PAID)

    Time frame: Baseline, week 28, 4-6 weeks post partum

    Diabetes stress

  8. World Health Organisation - Five Well-Being Index (WHO-5)

    Time frame: Baseline, week 28, 4-6 weeks post partum

    quality of life

  9. 12-Item Short-Form (SF12)

    Time frame: Baseline, week 28, 4-6 weeks post partum

    Health status

  10. Patient Assessment of Cronic Illness Care (PACIC)

    Time frame: Baseline, week 28, 4-6 weeks post partum

    Satisfaction with care

  11. Glucose Monitoring Satisfaction Survey (GMSS)

    Time frame: Baseline, week 28, 4-6 weeks post partum

    Satisfaction with method used for glucose measuring

  12. Pregnancy Physical Activity Questionnaire (PPAQ-DK

    Time frame: Baseline, week 28

    Physical activity in pregnancy

  13. Diet items from the National Danish Birth Cohort

    Time frame: Baseline, week 28

    Pregnancy specific questions related to diet

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Steno Diabetes Center Copenhagen
  • Steno Diabetes Center Nordjylland
  • Steno Diabetes Center Odense

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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