Continuous Glucose Monitoring for Women With Gestational Diabetes

Universitaire Ziekenhuizen KU Leuven386 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

386

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

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

...and 6 more locations

Outcomes

Primary Outcomes

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

Time frame: at delivery