Clinical trial NCT06903728: National Trial of CGM in Pregnant Women With Type 2 Diabetes
Official title: National forsøgsordning Med Glukosesensorer Til Type 2-diabetes: Glukosesensorer Til Gravide Med Type 2-diabetes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Pregnancy
Keywords: CGM in type 2 diabetes
CGM in pregnancy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Odense
name: Steno Diabetes Center Copenhagen
name: Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital
name: Steno Diabetes Center Nordjylland
First posted: 2025-04-01
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: HbA1c at end of pregnancy (week 36 of pregnancy)
timeFrame: baseline < week 14 of pregnancy, follow up week 36 of pregnancy
measure: child birth weight SD-score
timeFrame: at time of birth
Secondary outcomes:
measure: TIR, TAR, TBR
timeFrame: from enrollment to 4-6 weeks post partum
measure: Mean glucose
timeFrame: from enrollment to 4-6 weeks post partum
measure: Womens gestational wheight gain
timeFrame: from enrollment to birth
measure: Hypoglykemia among newborn
timeFrame: at time of birth
measure: Pregnancy related complications
timeFrame: from enrollment to birth
measure: Birth related complications
timeFrame: at time of birth
measure: Problem Areas in Diabetes (PAID)
timeFrame: Baseline, week 28, 4-6 weeks post partum
measure: World Health Organisation - Five Well-Being Index (WHO-5)
timeFrame: Baseline, week 28, 4-6 weeks post partum
measure: 12-Item Short-Form (SF12)
timeFrame: Baseline, week 28, 4-6 weeks post partum
measure: Patient Assessment of Cronic Illness Care (PACIC)
timeFrame: Baseline, week 28, 4-6 weeks post partum
measure: Glucose Monitoring Satisfaction Survey (GMSS)
timeFrame: Baseline, week 28, 4-6 weeks post partum
measure: Pregnancy Physical Activity Questionnaire (PPAQ-DK
timeFrame: Baseline, week 28
measure: Diet items from the National Danish Birth Cohort
timeFrame: Baseline, week 28
Other outcomes:
Locations:
Study officials:
References: