Continuous Glucose Monitoring for Women With Gestational Diabetes

Last updated: June 5, 2026
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes (Pediatric)

Diabetes Prevention

Treatment

Freestyle Libre 3

Glucometer

Clinical Study ID

NCT06310356
CORDELIA
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • Patient has a history of type 2 or type 1 diabetes, or presence of auto-immuneantibodies for type 1 diabetes

  • A physical or psychological disease likely to interfere with the conduct of thestudy (based on the evaluation by the treating physician).

  • Use of medication with significant impact on glycemia (such as high doseglucocorticoids and diabetes medication such as metformin)

  • Participation in an interventional Trial with an investigational medicinal productor device

  • Multiple pregnancy

  • History of bariatric surgery

  • Known allergy to the adhesives used with the continuous glucose monitoring

Study Design

Total Participants: 386
Treatment Group(s): 2
Primary Treatment: Freestyle Libre 3
Phase:
Study Start date:
November 18, 2024
Estimated Completion Date:
August 31, 2027

Study Description

At diagnosis of GDM, women will receive education on the management of GDM with lifestyle and need to monitor glucose with SMBG. Within one week of GDM diagnosis, all participants will be asked to use a blinded CGM (Freestyle Libre Pro IQ,) during a run-phase. Women randomized to the control arm, will be asked to intermittently wear a blinded CGM sensor (Freestyle Libre Pro IQ) during 14 days at least two time points in pregnancy (at 31.0-33.6 weeks and between 36.0-38.6 weeks). For women diagnosed with early GDM (<20 weeks), blinded CGM will be needed 3 times in pregnancy with a first time at 20.0-23.9 weeks. Women randomized to the intervention arm will be recommended tu use the rt-CGM (Freestyle Libre 3) till the delivery. In line with normal routine, a 75g OGTT will be performed between 6-24 weeks postpartum to screen for glucose intolerance. Participants will be asked to also wear a blinded CGM (Freestyle Libre Pro IQ) at this last study visit.

Connect with a study center

  • Campbelltown Hospital

    Sydney, CAMPBELLTOWN NSW 2560
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Sydney, Camperdown NSW 2050
    Australia

    Active - Recruiting

  • OLV Aalst-Asse

    Aalst, Oost-Vlaanderen 9300
    Belgium

    Active - Recruiting

  • UZA

    Antwerp,
    Belgium

    Active - Recruiting

  • ZNA Antwerpen

    Antwerp,
    Belgium

    Active - Recruiting

  • Imelda Bonheiden

    Bonheiden, 2820
    Belgium

    Active - Recruiting

  • AZ St Jan Brugge

    Bruges, 8000
    Belgium

    Active - Recruiting

  • Erasme

    Brussel,
    Belgium

    Active - Recruiting

  • Erasme

    Brussels,
    Belgium

    Active - Recruiting

  • AZ St Lucas Gent

    Gent,
    Belgium

    Active - Recruiting

  • AZ St Lucas Gent

    Ghent,
    Belgium

    Active - Recruiting

  • UZ Gent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • AZ Groeninge Kortrijk

    Kortrijk, 8510
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • CHU de Liège

    Liège,
    Belgium

    Active - Recruiting

  • AZ St Maarten Mechelen

    Mechelen,
    Belgium

    Active - Recruiting

  • AZ Oostende

    Ostend,
    Belgium

    Active - Recruiting

  • Vitaz

    Sint-Niklaas,
    Belgium

    Active - Recruiting

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