National Trial of CGM in Pregnant Women With Type 2 Diabetes

NCT ID: NCT06903728

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2026-12-31

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.

Conditions

Type 2 Diabetes; Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sensor use

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

Group Type: EXPERIMENTAL

continous glucose monitoring

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Odense

OTHER

Sponsor Role: collaborator

Steno Diabetes Center Copenhagen

OTHER

Sponsor Role: collaborator

Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital

UNKNOWN

Sponsor Role: collaborator

Steno Diabetes Center Nordjylland

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CGM til gravide med T2D

Identifier Type: -

Identifier Source: org_study_id