National Trial of CGM in Pregnant Women With Type 2 Diabetes

NCT06903728 | Not Yet Recruiting FDA Device

• 1 other identifier: CGM til gravide med T2D
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Keywords

CGM in type 2 diabetes; CGM in pregnancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• TIR, TAR, TBR

  from enrollment to 4-6 weeks post partum

• Mean glucose

  from enrollment to 4-6 weeks post partum

• Womens gestational wheight gain

  from enrollment to birth

• Hypoglykemia among newborn

  at time of birth

• Pregnancy related complications

  from enrollment to birth

Study Arms (1)

Sensor use

EXPERIMENTAL

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

Device: continous glucose monitoring

Interventions

continous glucose monitoring 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.

Sensor use

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women with type 2 diabetes
• attending one of the four centers for pregnancy and diabetes in Denmark
• years old or above

You may not qualify if:

• gestationel age 14+0 or above
• ekspected birth after end of trial
• already using a continous glucose monitor (sensor)

Sponsors & Collaborators

• Odense University Hospital: lead
• Steno Diabetes Center Odense: collaborator
• Steno Diabetes Center Copenhagen: collaborator
• Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital: collaborator
• Steno Diabetes Center Nordjylland: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: December 2025 and december 2026