National Trial of CGM in Pregnant Women With Type 2 Diabetes

National forsøgsordning Med Glukosesensorer Til Type 2-diabetes: Glukosesensorer Til Gravide Med Type 2-diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Type 2 Diabetes
• Intervention / Treatment: Device: continous glucose monitoring

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensor use; Participants are given a sensor to use during pregnancy until 4-6 weeks post partum	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: Steno Diabetes Center Copenhagen; Steno Diabetes Center Odense; Steno Diabetes Center Nordjylland; Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: CGM in type 2 diabetes; CGM in pregnancy
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: CGM til gravide med T2D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: December 2025 and december 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes