EICHORCondition: Gestational Diabetes · Sponsor: Universitaire Ziekenhuizen KU Leuven
Interested? Contact the study team ↓
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.
This description comes directly from the study's public registry record.
Katrien Benhalima, MD PhD · +3216340614 · katrien.benhalima@uzleuven.be
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Campbelltown Hospital | Sydney, CAMPBELLTOWN NSW, Australia | Recruiting |
| Royal Prince Alfred Hospital | Sydney, Camperdown NSW, Australia | Recruiting |
| OLV Aalst-Asse | Aalst, Oost-Vlaanderen, Belgium | Recruiting |
| UZA | Antwerp, Belgium | Recruiting |
| ZNA Antwerpen | Antwerp, Belgium | Recruiting |
| Imelda Bonheiden | Bonheiden, Belgium | Recruiting |
| AZ St Jan Brugge | Bruges, Belgium | Recruiting |
| Erasme | Brussels, Belgium | Recruiting |
| UZ Gent | Ghent, Belgium | Recruiting |
| AZ St Lucas Gent | Ghent, Belgium | Recruiting |
| AZ Groeninge Kortrijk | Kortrijk, Belgium | Recruiting |
| UZ Leuven | Leuven, Belgium | Recruiting |
+ 4 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT06310356