Continuous Glucose Monitoring for Women With Gestational Diabetes

Gestational Diabetes Clinical Trial

— CORDELIA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310356
• Other study ID #: CORDELIA
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: February 2027

Study information

• Verified date: February 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Katrien Benhalima, MD PhD
• Phone: +3216340614
• Email: katrien.benhalima[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 17 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 386
• Est. completion date: February 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Device:
• Freestyle Libre 3
CGM
• Glucometer
SMBG

Locations

Country	Name	City	State
Belgium	OLV Aalst-Asse	Aalst	Oost-Vlaanderen
Belgium	UZA	Antwerp
Belgium	ZNA Antwerpen	Antwerp
Belgium	Imelda Bonheiden	Bonheiden
Belgium	AZ St Jan Brugge	Brugge
Belgium	Erasme	Brussel
Belgium	UCL	Brussel
Belgium	AZ St Lucas Gent	Gent
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge Kortrijk	Kortrijk
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège	Liège
Belgium	AZ St Maarten Mechelen	Mechelen
Belgium	Centre Hospitalier Mouscron	Mouscron
Belgium	AZ Delta Roeselare	Roeselare
Belgium	Vitaz	Sint-Niklaas
Belgium	AZ Turnhout	Turnhout

Sponsors (17)

Lead Sponsor

Collaborator

Universitaire Ziekenhuizen KU Leuven

AZ Delta, AZ Sint-Lucas Gent, AZ St Maarten Mechelen, AZ St- Jan Brugge, AZ Turnhout, Centre Hospitalier Mouscron, Centre Hospitalier Universitaire de Liege, Erasme University Hospital, General Hospital Groeninge, Imelda Hospital, Bonheiden, Onze Lieve Vrouw Hospital, Université Catholique de Louvain, University Hospital, Antwerp, University Hospital, Ghent, Vitaz, Ziekenhuis Netwerk Antwerpen (ZNA)

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	timing of start insulin treatment	gestational age at start insulin treatment	from GDM diagnosis till delivery
Secondary	mean insulin dose	dose of short and/or long)actinbg insulin	from GDM diagnosis till delivery
Secondary	mean gestational weight gain	weight gain in pregnancy	at delivery
Secondary	rate of postpartum hemorrhage	hemorrhage with delivery	at delivery
Secondary	rate of macrosomia	birth weight >4Kg	at delivery
Secondary	rate of baby >4.5Kg	birth weight >4.5Kg	at delivery
Secondary	rate of Small-for-gestational age infant	birth weight <10Th percentile	at delivery
Secondary	rate of cesarean section	total (planned and emergency) number of cesarean sections	at delivery
Secondary	rate of instrumental delivery	delivery with forceps or vacuum	at delivery
Secondary	rate of perineal inury	3dr or 4th degree perineal laceration	at delivery
Secondary	rate of labor inductions	induction of labor	at delivery
Secondary	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
Secondary	rate of gestational hypertension	=20 weeks of gestation: blood pressure =140/90mmHg	at delivery
Secondary	rate of fetal malformation	congenital malformation	at delivery
Secondary	rate of miscarriage	fetal loss <20 weeks gestation	at delivery
Secondary	rate of polycythemia	increased hematocrite accoridng to local practice	at delivery
Secondary	rate of neonatal hypoglycemia	bypoglycemia at birth <40mg/dl	at delivery
Secondary	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
Secondary	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
Secondary	dietary intake	Frequyency Food Questionnaire	baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
Secondary	Physical activity	International Physical Activity questionnaire score	baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
Secondary	fear for hypoglycaemia	the Hypoglycaemia Fear Survey II	between 36.0-38.6 weeks
Secondary	fear for hyperglycaemia	self-designed questionnaire on fear for hyperglycaemia	between 36.0-38.6 weeks
Secondary	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
Secondary	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
Secondary	user-friendliness of CGM	self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM)	between 36.0-38.6 weeks
Secondary	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
Secondary	duration of breastfeeding	breastfeeding duration (exclusive or half formula) duration in months	postpartum between 6-24 weeks
Secondary	rate of hypercholesterolemia	lipid profile with LDL-cholesterol and Triglycerides	postpartum between 6-24 weeks
Secondary	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
Secondary	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
Secondary	day glucose time in range <70mg/dl	glucose time below 70-mg/dl from 6am till 00	postpartum between 6-24 weeks
Secondary	night glucose time in range <70mg/dl	glucose time below 70-mg/dl from 00 till 6am	postpartum between 6-24 weeks
Secondary	night glucose time in range >180mg/dl	glucose time above 180mg/dl from 00 till 6am	postpartum between 6-24 weeks
Secondary	day glucose time in range >180mg/dl	glucose time above 180mg/dl from 6am till 00	postpartum between 6-24 weeks