Continuous Glucose Monitoring for Women with Gestational Diabetes

NCT ID: NCT06310356

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-18

Study Completion Date

2027-02-28

Brief Summary

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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 open-label multi-centric RCT with 14 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.

Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous glucose monitoring

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

Group Type EXPERIMENTAL

Freestyle Libre 3

Intervention Type DEVICE

CGM

self monitoring of blood glucose with glucometer

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

Group Type ACTIVE_COMPARATOR

Glucometer

Intervention Type DEVICE

SMBG

Interventions

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Freestyle Libre 3

CGM

Intervention Type DEVICE

Glucometer

SMBG

Intervention Type DEVICE

Eligibility Criteria

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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 Criteria

* 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)
* Participation in an interventional Trial with an investigational medicinal product or device
* Multiple pregnancy
* History of bariatric surgery
* Known allergy to the adhesives used with the continuous glucose monitoring
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Antwerp

OTHER

Sponsor Role collaborator

General Hospital Groeninge

OTHER

Sponsor Role collaborator

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role collaborator

Ziekenhuis Netwerk Antwerpen (ZNA)

OTHER

Sponsor Role collaborator

Vitaz

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role collaborator

Erasme University Hospital

OTHER

Sponsor Role collaborator

Université Catholique de Louvain

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role collaborator

AZ Sint-Lucas Gent

OTHER

Sponsor Role collaborator

AZ Sint-Lucas Brugge

OTHER

Sponsor Role collaborator

AZ St Maarten Mechelen

UNKNOWN

Sponsor Role collaborator

Imelda Hospital, Bonheiden

OTHER

Sponsor Role collaborator

AZ Oostende

UNKNOWN

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OLV Aalst-Asse

Aalst, Oost-Vlaanderen, Belgium

Site Status RECRUITING

UZA

Antwerp, , Belgium

Site Status RECRUITING

ZNA Antwerpen

Antwerp, , Belgium

Site Status RECRUITING

Imelda Bonheiden

Bonheiden, , Belgium

Site Status RECRUITING

AZ St Jan Brugge

Bruges, , Belgium

Site Status RECRUITING

Erasme

Brussels, , Belgium

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

AZ St Lucas Gent

Ghent, , Belgium

Site Status RECRUITING

AZ Groeninge Kortrijk

Kortrijk, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

CHU de Liège

Liège, , Belgium

Site Status RECRUITING

AZ St Maarten Mechelen

Mechelen, , Belgium

Site Status RECRUITING

AZ Oostende

Ostend, , Belgium

Site Status RECRUITING

Vitaz

Sint-Niklaas, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Katrien Benhalima, MD PhD

Role: CONTACT

+3216340614

Facility Contacts

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Inge Van Pottelbergh, MD PhD

Role: primary

Niels Bochanen

Role: primary

Astrid Morrens, MD

Role: primary

Da Hae Lee, MD

Role: primary

Sara Vandewalle

Role: primary

Tiphaine Carton

Role: primary

Joke Marlier, MD

Role: primary

Inge Van Boxelaer

Role: primary

Ellen Heyns, MD

Role: primary

Katrien Benhalima, MD PhD

Role: primary

JC Philips

Role: primary

Kathleen Bollaerts

Role: primary

Linsey Winne

Role: primary

Peter Coremans

Role: primary

Other Identifiers

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CORDELIA

Identifier Type: -

Identifier Source: org_study_id

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