Continuous Glucose Monitoring for Women with Gestational Diabetes
NCT ID: NCT06310356
Last Updated: 2025-02-07
Study Results
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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RECRUITING
NA
386 participants
INTERVENTIONAL
2024-11-18
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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continuous glucose monitoring
continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3
Freestyle Libre 3
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
Glucometer
SMBG
Interventions
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Freestyle Libre 3
CGM
Glucometer
SMBG
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Antwerp
OTHER
General Hospital Groeninge
OTHER
Onze Lieve Vrouw Hospital
OTHER
Ziekenhuis Netwerk Antwerpen (ZNA)
OTHER
Vitaz
OTHER
Centre Hospitalier Universitaire de Liege
OTHER
Erasme University Hospital
OTHER
Université Catholique de Louvain
OTHER
University Hospital, Ghent
OTHER
AZ Sint-Lucas Gent
OTHER
AZ Sint-Lucas Brugge
OTHER
AZ St Maarten Mechelen
UNKNOWN
Imelda Hospital, Bonheiden
OTHER
AZ Oostende
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium
UZA
Antwerp, , Belgium
ZNA Antwerpen
Antwerp, , Belgium
Imelda Bonheiden
Bonheiden, , Belgium
AZ St Jan Brugge
Bruges, , Belgium
Erasme
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
AZ St Lucas Gent
Ghent, , Belgium
AZ Groeninge Kortrijk
Kortrijk, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liège
Liège, , Belgium
AZ St Maarten Mechelen
Mechelen, , Belgium
AZ Oostende
Ostend, , Belgium
Vitaz
Sint-Niklaas, , Belgium
Countries
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Central Contacts
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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
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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