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Continuous glucose sensor versus finger-prick testing in pregnancy with gestational diabetes

Compares a wearable glucose sensor with usual finger-prick checks in women with gestational diabetes.

Key facts

Who runs it
Universitaire Ziekenhuizen KU Leuven
Where
Australia and Belgium16 sites in 2 countriesChoose a country to see its sites
Trial code
Registry title
Continuous Glucose Monitoring for Women With Gestational Diabetes
Status
Recruiting
People taking part
386 people, planned
Started
18 Nov 2024
Expected to end
Aug 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Freestyle Libre 3
  • Glucometer
Record updated
9 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant women with gestational diabetes (diabetes that starts in pregnancy). They will use either a continuous glucose sensor or usual finger-prick checks.

Age
18 years or older
Sex
Women only
Disease stage
Gestational diabetes diagnosed before 29.6 weeks of pregnancy. Early and late gestational diabetes both count. Pregnant with one baby only.
Earlier treatment
Cannot join if using medicines with a strong effect on blood sugar, such as high dose glucocorticoids or metformin.

Main reasons for not taking part

  • Past type 1 or type 2 diabetes, or type 1 diabetes autoimmune antibodies
  • Pregnant with more than one baby
  • Past weight-loss (bariatric) surgery
  • Known allergy to the sensor adhesives
  • Taking part in another trial of a drug or device under study

This trial only enrols pregnant participants. The registry sentence this rests on: Singleton pregnancy

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • At least 18 years of age at the time of signing the Informed Consent Form (ICF)
  • Singleton pregnancy
  • Diagnosed with gestational diabetes before 29.6 weeks of pregnancy
  • Needs to be able to understand and speak Dutch, French or English
  • Have email access

Who cannot take part

  • Patient has a history of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes
  • A physical or psychological disease likely to interfere with the conduct of the study (based on the evaluation by the treating physician)
  • Use of medication with significant impact on glycemia (such as high dose glucocorticoids and diabetes medication such as metformin)
  • History of bariatric surgery
  • Known allergy to the adhesives used with the continuous glucose monitoring
  • Participation in an interventional Trial with an investigational medicinal product or device
  • Multiple pregnancy

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian-Australian open-label multi-centric RCT with 16 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3 +) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.

The 2 groups in the trial

  • continuous glucose monitoringTreatment being tested

    continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3

    Treatment: Freestyle Libre 3

  • self monitoring of blood glucose with glucometerExisting treatment, for comparison

    self monitoring of blood glucose with glucometer, at least 2 days per week if treated with lifestyle and daily if additional treatment with insulin is started

    Treatment: Glucometer

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial
Plain-language title
Continuous glucose sensor versus finger-prick testing in pregnancy with gestational diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Publications
Record updated
9 June 2026