National Trial of CGM in Pregnant Women With Type 2 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes; Pregnancy

• Registration Number: NCT06903728
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study Start: 2025-04
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
HbA1c at end of pregnancy (week 36 of pregnancy)	baseline < week 14 of pregnancy, follow up week 36 of pregnancy
child birth weight SD-score	at time of birth

Secondary Outcome Measures

Name	Time	Method
Mean glucose	from enrollment to 4-6 weeks post partum	Sensor specific data
Birth related complications	at time of birth	c-section, early birth
Problem Areas in Diabetes (PAID)	Baseline, week 28, 4-6 weeks post partum	Diabetes stress
TIR, TAR, TBR	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.
Womens gestational wheight gain	from enrollment to birth	weight gain during throughout pregnancy
Hypoglykemia among newborn	at time of birth	Hypoglykemia among newborn
Pregnancy related complications	from enrollment to birth	increased blood pressure and preeclampsia
World Health Organisation - Five Well-Being Index (WHO-5)	Baseline, week 28, 4-6 weeks post partum	quality of life
12-Item Short-Form (SF12)	Baseline, week 28, 4-6 weeks post partum	Health status
Patient Assessment of Cronic Illness Care (PACIC)	Baseline, week 28, 4-6 weeks post partum	Satisfaction with care
Glucose Monitoring Satisfaction Survey (GMSS)	Baseline, week 28, 4-6 weeks post partum	Satisfaction with method used for glucose measuring
Pregnancy Physical Activity Questionnaire (PPAQ-DK	Baseline, week 28	Physical activity in pregnancy
Diet items from the National Danish Birth Cohort	Baseline, week 28	Pregnancy specific questions related to diet