Continuous Glucose Monitoring for Women With Gestational Diabetes

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT06310356
Status
Recruiting
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Conditions

  • Gestational Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Freestyle Libre 3 — DEVICE
    CGM
  • Glucometer — DEVICE
    SMBG

Study Details

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.

Key Dates

First listed
Mar 15, 2024
Start date
Nov 18, 2024
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
386 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: continuous glucose monitoring
    continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3
  • 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

Primary Outcome Measure

a composite of pregnancy outcomes [ Time Frame: at delivery ]

Central Contacts

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