Actively Recruiting
Continuous Glucose Monitoring for Women With Gestational Diabetes
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
386
Participants Needed
14
Research Sites
140 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
U
University Hospital, Antwerp
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Continuous Glucose Monitoring for Women With Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- History of type 2 or type 1 diabetes, or presence of auto-immune antibodies for type 1 diabetes
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
OLV Aalst-Asse
Aalst, Oost-Vlaanderen, Belgium, 9300
Actively Recruiting
2
UZA
Antwerp, Belgium
Actively Recruiting
3
ZNA Antwerpen
Antwerp, Belgium
Actively Recruiting
4
Imelda Bonheiden
Bonheiden, Belgium, 2820
Actively Recruiting
5
AZ St Jan Brugge
Bruges, Belgium, 8000
Actively Recruiting
6
Erasme
Brussels, Belgium
Actively Recruiting
7
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
8
AZ St Lucas Gent
Ghent, Belgium
Actively Recruiting
9
AZ Groeninge Kortrijk
Kortrijk, Belgium, 8510
Actively Recruiting
10
UZ Leuven
Leuven, Belgium
Actively Recruiting
11
CHU de Liège
Liège, Belgium
Actively Recruiting
12
AZ St Maarten Mechelen
Mechelen, Belgium
Actively Recruiting
13
AZ Oostende
Ostend, Belgium
Actively Recruiting
14
Vitaz
Sint-Niklaas, Belgium
Actively Recruiting
Research Team
K
Katrien Benhalima, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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