National Trial of CGM in Pregnant Women With Type 2 Diabetes

Odense University Hospital

Status: Begins enrollment this month

Conditions: Type 2 Diabetes; Pregnancy

Treatments: Device: continous glucose monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06903728

CGM til gravide med T2D

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Sensor use

Experimental group

Description:

Participants are given a sensor to use during pregnancy until 4-6 weeks post partum

Treatment:

Device: continous glucose monitoring