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Not yet recruiting NCT06903728

National Trial of CGM in Pregnant Women With Type 2 Diabetes

No phase Interventional Type 2 Diabetes Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: continous glucose monitoring.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • HbA1c at end of pregnancy (week 36 of pregnancy) [Time frame: baseline < week 14 of pregnancy, follow up week 36 of pregnancy]
  • child birth weight SD-score [Time frame: at time of birth]
Secondary outcome measures (12)
  • TIR, TAR, TBR [Time frame: from enrollment to 4-6 weeks post partum]
  • Mean glucose [Time frame: from enrollment to 4-6 weeks post partum]
  • Womens gestational wheight gain [Time frame: from enrollment to birth]
  • Hypoglykemia among newborn [Time frame: at time of birth]
  • Pregnancy related complications [Time frame: from enrollment to birth]
  • Birth related complications [Time frame: at time of birth]
  • Problem Areas in Diabetes (PAID) [Time frame: Baseline, week 28, 4-6 weeks post partum]
  • World Health Organisation - Five Well-Being Index (WHO-5) [Time frame: Baseline, week 28, 4-6 weeks post partum]
  • 12-Item Short-Form (SF12) [Time frame: Baseline, week 28, 4-6 weeks post partum]
  • Patient Assessment of Cronic Illness Care (PACIC) [Time frame: Baseline, week 28, 4-6 weeks post partum]
  • Glucose Monitoring Satisfaction Survey (GMSS) [Time frame: Baseline, week 28, 4-6 weeks post partum]
  • Pregnancy Physical Activity Questionnaire (PPAQ-DK [Time frame: Baseline, week 28]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06903728 · CGM til gravide med T2D

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗