Continuous Glucose Monitoring for Women with Gestational Diabetes, CORDELIA: A Multicentric Randomized Controlled Trial, Methodology and Design.
18 affiliations
- 1Department of Chronic Diseases and Metabolism, Clinical and Experimental Endocrinology, KU Leuven, 3000 Leuven, Belgium.
- 2Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, 2650 Edegem, Belgium.
- 3Department of Endocrinology, General Hospital Groeninge Kortrijk, 8500 Kortrijk, Belgium.
- 4Department of Endocrinology, AZORG Aalst, 9300 Aalst, Belgium.
- 5Department of Endocrinology, ZAS Palfijn, 2170 Merksem, Belgium.
- 6Department of Endocrinology-Diabetology, Vitaz, 9100 Sint-Niklaas, Belgium.
- 7Department of Diabetology, Nutrition and Metabolic Diseases, CHU de Liège, 4000 Liège, Belgium.
- 8Department of Endocrinology, Erasme Hospital, 1070 Brussels, Belgium.
- 9Department of Endocrinology-Diabetology, AZ Sint-Jan Brugge, 8000 Brugge, Belgium.
- 10Department of Endocrinology, UZ Gent, 9000 Gent, Belgium.
- 11Department of Endocrinology, AZ Sint Lucas Gent, 9000 Gent, Belgium.
- 12Department of Endocrinology, AZ Oostende, 8400 Oostende, Belgium.
- 13Department of Endocrinology, AZ Sint Maarten Mechelen, 2800 Mechelen, Belgium.
- 14Department of Endocrinology, Imelda Bonheiden, 2820 Bonheiden, Belgium.
- 15School of Medicine, Western Sydney University, Sydney, NSW 2560, Australia.
- 16Department of Endocrinology, Royal Prince Alfred Hospital and Charles Perkins Centre, University of Sydney, Sydney, NSW 2050, Australia.
- 17Leuven Biostatistics and Statistical Bioinformatics Centre, KU Leuven, 3000 Leuven, Belgium.
- 18Department of Endocrinology, University Hospitals Leuven, 3000 Leuven, Belgium.
Abstract
Background/Objectives: Gestational diabetes mellitus (GDM) is associated with increased short- and long-term risks for both mother and child. Screening and treatment between 24 and 30 weeks' gestation reduces adverse pregnancy outcomes, while emerging evidence suggests that earlier diagnosis and treatment (<20 weeks') in high-risk populations may further improve neonatal outcomes. Currently, self-monitoring of blood glucose (SMBG) remains the standard of care for management but provides only intermittent glycemic data and limited insight into overall glucose patterns. Real-time continuous glucose monitoring (rt-CGM) has transformed management in pregnancies complicated by type 1 diabetes but has shown conflicting results in GDM; it is thus unclear whether similar benefits may extend to women with GDM, including women with early GDM. Methods: The Continuous Glucose Monitoring for Women With Gestational Diabetes (CORDELIA) study is an ongoing, large, open-label, multicenter randomized controlled trial conducted across 14 centers in Belgium and two centers in Australia. Women diagnosed with GDM are randomized in a 1:1 ratio to either rt-CGM (intervention group) or standard care with SMBG (control group). Both women with early GDM diagnosed before 20 weeks' gestation and those diagnosed between 24.0 and 29.6 weeks' gestation are included. Participants attend the following visits: baseline visit at GDM diagnosis, an additional visit at 20.0-23.9 weeks' (if early GDM), 31.0-33.6 weeks' and 36.0-38.6 weeks', and a postpartum oral glucose tolerance test (OGTT) assessment (6.0-23.6 weeks after delivery). At each visit, clinical assessment, HbA1c, and (blinded) CGM are evaluated, alongside validated patient-reported outcome questionnaires. The primary objective is to compare the incidence of a composite of adverse pregnancy outcomes between the rt-CGM and SMBG groups. The primary outcome is a composite of adverse pregnancy outcomes including preterm delivery <37 weeks, LGA [customized percentiles according to Gestation Related Optimal Weight chart (GROW)], neonatal hypoglycemia requiring intravenous dextrose, neonatal intensive care unit (NICU) admission > 24 h, neonatal respiratory distress, stillbirth or neonatal death, phototherapy, birth trauma, and shoulder dystocia. Secondary outcomes include maternal glycemia, insulin use, pregnancy and neonatal outcomes, glycemic variability, patient-reported outcomes, and prespecified secondary analyses according to timing of GDM diagnosis and maternal BMI. Trial Registration: ClinicalTrials.gov: NCT06310356. First posted: 15 March 2024.
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BibTeX
@article{geerts2026continuous,
title = {{Continuous Glucose Monitoring for Women with Gestational Diabetes, CORDELIA: A Multicentric Randomized Controlled Trial, Methodology and Design.}},
author = {Ina Geerts and Catherine Yu and Niels Bochanen and Ellen Heyns and Inge Van Pottelbergh and Astrid Morrens and Peter Coremans and Jean-Christophe Philips and Tiphaine Carton and Sara Vandewalle and Joke Marlier and Inge Van Boxelaer and Linsey Winne and Kathleen Bollaerts and Dahae Lee and David Simmons and Arianne Sweeting and Annouschka Laenen and Chantal Mathieu and Katrien Benhalima},
journal = {Journal of clinical medicine},
year = {2026},
month = sep,
doi = {10.3390/jcm15197581},
url = {https://europepmc.org/article/MED/42882043},
note = {CC BY},
}
RIS
TY - JOUR
TI - Continuous Glucose Monitoring for Women with Gestational Diabetes, CORDELIA: A Multicentric Randomized Controlled Trial, Methodology and Design.
AU - Ina Geerts
AU - Catherine Yu
AU - Niels Bochanen
AU - Ellen Heyns
AU - Inge Van Pottelbergh
AU - Astrid Morrens
AU - Peter Coremans
AU - Jean-Christophe Philips
AU - Tiphaine Carton
AU - Sara Vandewalle
AU - Joke Marlier
AU - Inge Van Boxelaer
AU - Linsey Winne
AU - Kathleen Bollaerts
AU - Dahae Lee
AU - David Simmons
AU - Arianne Sweeting
AU - Annouschka Laenen
AU - Chantal Mathieu
AU - Katrien Benhalima
PY - 2026
DA - 2026/09/29
JO - Journal of clinical medicine
DO - 10.3390/jcm15197581
UR - https://europepmc.org/article/MED/42882043
AB - Background/Objectives: Gestational diabetes mellitus (GDM) is associated with increased short- and long-term risks for both mother and child. Screening and treatment between 24 and 30 weeks' gestation reduces adverse pregnancy outcomes, while emerging evidence suggests that earlier diagnosis and treatment (<20 weeks') in high-risk populations may further improve neonatal outcomes. Currently, self-monitoring of blood glucose (SMBG) remains the standard of care for management but provides only intermittent glycemic data and limited insight into overall glucose patterns. Real-time continuous glucose monitoring (rt-CGM) has transformed management in pregnancies complicated by type 1 diabetes but has shown conflicting results in GDM; it is thus unclear whether similar benefits may extend to women with GDM, including women with early GDM. Methods: The Continuous Glucose Monitoring for Women With Gestational Diabetes (CORDELIA) study is an ongoing, large, open-label, multicenter randomized controlled trial conducted across 14 centers in Belgium and two centers in Australia. Women diagnosed with GDM are randomized in a 1:1 ratio to either rt-CGM (intervention group) or standard care with SMBG (control group). Both women with early GDM diagnosed before 20 weeks' gestation and those diagnosed between 24.0 and 29.6 weeks' gestation are included. Participants attend the following visits: baseline visit at GDM diagnosis, an additional visit at 20.0-23.9 weeks' (if early GDM), 31.0-33.6 weeks' and 36.0-38.6 weeks', and a postpartum oral glucose tolerance test (OGTT) assessment (6.0-23.6 weeks after delivery). At each visit, clinical assessment, HbA1c, and (blinded) CGM are evaluated, alongside validated patient-reported outcome questionnaires. The primary objective is to compare the incidence of a composite of adverse pregnancy outcomes between the rt-CGM and SMBG groups. The primary outcome is a composite of adverse pregnancy outcomes including preterm delivery <37 weeks, LGA [customized percentiles according to Gestation Related Optimal Weight chart (GROW)], neonatal hypoglycemia requiring intravenous dextrose, neonatal intensive care unit (NICU) admission > 24 h, neonatal respiratory distress, stillbirth or neonatal death, phototherapy, birth trauma, and shoulder dystocia. Secondary outcomes include maternal glycemia, insulin use, pregnancy and neonatal outcomes, glycemic variability, patient-reported outcomes, and prespecified secondary analyses according to timing of GDM diagnosis and maternal BMI. Trial Registration: ClinicalTrials.gov: NCT06310356. First posted: 15 March 2024.
SN - 2077-0383
ER -