MedTrace Logo

National Trial of CGM in Pregnant Women With Type 2 Diabetes

NCT06903728 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Steno Diabetes Center Odense

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital

    collaborator UNKNOWN

  • Steno Diabetes Center Nordjylland

    collaborator OTHER

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06903728 on ClinicalTrials.gov