Continuous Glucose Monitoring for Women with Gestational Diabetes (CORDELIA)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Gestational Diabetes

Treatments: Device: Glucometer; Device: Freestyle Libre 3

Study type: Interventional

Funder types: Other

Identifiers

NCT06310356

CORDELIA

Details and patient eligibility

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.

Full 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.

Enrollment: 386 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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386 participants in 2 patient groups

continuous glucose monitoring

Experimental group

Description:

continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3

Treatment:

Device: Freestyle Libre 3

self monitoring of blood glucose with glucometer

Active Comparator group

Description:

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

Treatment:

Device: Glucometer