Continuous Glucose Monitoring for Women With Gestational Diabetes (CORDELIA)

Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Device: Freestyle Libre 3; Device: Glucometer

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 386
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katrien Benhalima, MD PhD; Phone Number: +3216340614; Email: katrien.benhalima@uzleuven.be

Study Locations

• Belgium
  • Antwerp, Belgium
    • Recruiting
    • UZA
    • Contact: Niels Bochanen
  • Antwerp, Belgium
    • Recruiting
    • ZNA Antwerpen
    • Contact: Astrid Morrens, MD
  • Bonheiden, Belgium, 2820
    • Recruiting
    • Imelda Bonheiden
    • Contact: Da Hae Lee, MD
  • Bruges, Belgium, 8000
    • Recruiting
    • AZ St Jan Brugge
    • Contact: Sara Vandewalle
  • Brussels, Belgium
    • Recruiting
    • Erasme
    • Contact: Tiphaine Carton
  • Ghent, Belgium, 9000
    • Recruiting
    • UZ Gent
    • Contact: Joke Marlier, MD
  • Ghent, Belgium
    • Recruiting
    • AZ St Lucas Gent
    • Contact: Inge Van Boxelaer
  • Kortrijk, Belgium, 8510
    • Recruiting
    • AZ Groeninge Kortrijk
    • Contact: Ellen Heyns, MD
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Katrien Benhalima, MD PhD; Email: katrien.benhalima@uzleuven.be
  • Liège, Belgium
    • Recruiting
    • CHU de Liege
    • Contact: JC Philips
  • Mechelen, Belgium
    • Recruiting
    • AZ St Maarten Mechelen
    • Contact: Kathleen Bollaerts
  • Ostend, Belgium
    • Recruiting
    • AZ Oostende
    • Contact: Linsey Winne
  • Sint-Niklaas, Belgium
    • Recruiting
    • VITAZ
    • Contact: Peter Coremans
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium, 9300
      • Recruiting
      • OLV Aalst-Asse
      • Contact: Inge Van Pottelbergh, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: continuous glucose monitoring; continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3	Device: Freestyle Libre 3; CGM
Active Comparator: 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	Device: Glucometer; SMBG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a composite of pregnancy outcomes	Hence, the primary outcome is a binary variable, taking the value 1 if at least one of the adverse pregnancy outcomes occurs, or zero otherwise:preterm delivery <37 weeks, large-for-gestational age infant, neonatal hypoglycaemia, (requiring intravenous dextrose), NICU admission (>24h), respiratory distress (at least 4 hours of respiratory support with supplemental oxygen, CPAP, or intermittent positive-pressure ventilation during the first 24 hours after delivery), stillbirth or neonatal death, phototherapy for jaundice, birth trauma and shoulder dystocia	at delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time in glucose range overnight between 70-95mg/dl	time in range from 00 till 6am between 70-95mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range during the day between 70-95mg/dl	time in range from 06 am til 00 between 70-95mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range overnight between 63-140mg/dl	time in range from 00 till 6am between 63-140mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation
time in glucoserange during the day between 63-140mg/dl	time in range from 06 am til 00 between 63-140mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range during the day between 54-95mg/dl	time in range from 06 am til 00 between 54-95mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range overnight between 54-95mg/dl	time in range from 00 till 6am between 54-95mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range overnight between 63-120mg/dl	time in range from 00 till 6am between 63-120mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
time in glucose range during the day between 63-120mg/dl	time in range from 06 am til 00 between 63-120mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
hypoglycemia <54mg/dl	time below 54mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
hypoglycemia <50mg/dl	time below 50mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
hypoglycemia <63mg/dl	time below 63mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
hypoglycemia <70mg/dl	time below 70mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
standard deviation	glycemic variability measured by standard deviation (SD)	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
Coefficient of Variance	glycemic variability measured by coefficient of variance (CV)	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
mean amplitude of glycemic excursions	glycemic variability measured by mean amplitude of glycemic excursions (MAGE)	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
glucose time overnight >100mg/dl	time in range from 00 till 6am >100mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
glucose postprandial time >120mg/dl	postprandial time >120mg/dl 2hours after the meal	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
glucose postprandial time >140mg/dl	postprandial time >140mg/dl 1hour after the meal	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
glucose time >180mg/dl	time >180mg/dl	during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
Glucose management indicator	Glucose management indicator, GMI	between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
timing of start insulin treatment	gestational age at start insulin treatment	from GDM diagnosis till delivery
Treatment satisfaction	diabetes treatment satisfaction questionnaire score, the higher the score the more satisfied, max. score of 48	between 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
Quality of life based on Short Form (SF-36) score	Short Form (SF-36) score, the higher the score the higher the Quality of life with a max score of 100	baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
dietary intake	Frequyency Food Questionnaire	baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
Physical activity	International Physical Activity questionnaire score	baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
fear for hypoglycaemia	the Hypoglycaemia Fear Survey II	between 36.0-38.6 weeks
fear for hyperglycaemia	self-designed questionnaire on fear for hyperglycaemia	between 36.0-38.6 weeks
symptoms of depression	the 20-item Center for Epidemiologic Studies-Depression (CES-D) , questionnaire, max. score 60 (the higher the more symptoms of depression)	baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
symptoms of anxiety	validated six-item short-form STAI questionnaire on anxiety, max. score of 24 (the higher the more anxiety)	baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
user-friendliness of CGM	self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM)	between 36.0-38.6 weeks
user-friendliness of CGM compared to oral glucose tolerance test (OGTT)	self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM) compared to OGTT	between 6-24 weeks postpartum
duration of breastfeeding	breastfeeding duration (exclusive or half formula) duration in months	postpartum between 6-24 weeks
night glucose time in range between 70-180mg/dl	glucose time in range between 70-180mg/dl from 00 til 6am	postpartum between 6-24 weeks
day glucose time in range between 70-180mg/dl	glucose time in range between 70-180mg/dl from 6am till 00	postpartum between 6-24 weeks
day glucose time in range <70mg/dl	glucose time below 70-mg/dl from 6am till 00	postpartum between 6-24 weeks
night glucose time in range <70mg/dl	glucose time below 70-mg/dl from 00 till 6am	postpartum between 6-24 weeks
night glucose time in range >180mg/dl	glucose time above 180mg/dl from 00 till 6am	postpartum between 6-24 weeks
day glucose time in range >180mg/dl	glucose time above 180mg/dl from 6am till 00	postpartum between 6-24 weeks
mean HbA1c	glycated Hb	between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
mean insulin dose	dose of short and/or long)actinbg insulin	from GDM diagnosis till delivery
mean gestational weight gain	weight gain in pregnancy	at delivery
rate of postpartum hemorrhage	hemorrhage with delivery	at delivery
rate of macrosomia	birth weight >4Kg	at delivery
rate of baby >4.5Kg	birth weight >4.5Kg	at delivery
rate of Small-for-gestational age infant	birth weight <10Th percentile	at delivery
rate of cesarean section	total (planned and emergency) number of cesarean sections	at delivery
rate of instrumental delivery	delivery with forceps or vacuum	at delivery
rate of perineal inury	3dr or 4th degree perineal laceration	at delivery
rate of labor inductions	induction of labor	at delivery
rate of preeclamspia	[≥20 weeks of gestation: new onset of hypertension and proteinuria or the new onset of hypertension and significant end-organ dysfunction with or without proteinuria (dipstick ≥ 2+, ≥0.3 g protein/24 hours or ≥30 mg/dL protein in spot urine or spot urine protein / creatinine ratio ≥30 mg protein/mmol creatinine	at delivery
rate of gestational hypertension	≥20 weeks of gestation: blood pressure ≥140/90mmHg	at delivery
rate of fetal malformation	congenital malformation	at delivery
rate of miscarriage	fetal loss <20 weeks gestation	at delivery
rate of polycythemia	increased hematocrite accoridng to local practice	at delivery
rate of neonatal hypoglycemia	bypoglycemia at birth <40mg/dl	at delivery
rate of hypercholesterolemia	lipid profile with LDL-cholesterol and Triglycerides	postpartum between 6-24 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: University Hospital, Ghent; University Hospital, Antwerp; Imelda Hospital, Bonheiden; Onze Lieve Vrouw Hospital; General Hospital Groeninge; Ziekenhuis Netwerk Antwerpen (ZNA); Université Catholique de Louvain; AZ Sint-Lucas Gent; Erasme University Hospital; AZ Sint-Lucas Brugge; Centre Hospitalier Universitaire de Liege; Vitaz; AZ St Maarten Mechelen; AZ Oostende

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gestational diabetes; continuous glucose monitoring; early gestational diabetes
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational
• Other Study ID Numbers: CORDELIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No