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Gestational DiabetesCORDELIANCT06310356

Continuous Glucose Monitoring for Women With Gestational Diabetes

A study testing Freestyle Libre 3 and Glucometer in people with Gestational Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 16 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gestational Diabetes
What is being tested?
Freestyle Libre 3 and Glucometer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
16 sitesin 2 countries
Study dates
18 Nov 2024to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Katrien Benhalima, MD PhD contact

+3216340614

katrien.benhalima@uzleuven.be

16 sites in 2 countries

Belgium14 sites, 14 recruiting

  • OLV Aalst-Asse

    Aalst, Oost-Vlaanderen, 9300

    Inge Van Pottelbergh, MD PhD

    Recruiting

  • UZA

    Antwerp

    Niels Bochanen

    Recruiting

  • ZNA Antwerpen

    Antwerp

    Astrid Morrens, MD

    Recruiting

  • Imelda Bonheiden

    Bonheiden, 2820

    Da Hae Lee, MD

    Recruiting

  • AZ St Jan Brugge

    Bruges, 8000

    Sara Vandewalle

    Recruiting

  • Erasme

    Brussels

    Tiphaine Carton

    Recruiting

  • UZ Gent

    Ghent, 9000

    Joke Marlier, MD

    Recruiting

  • AZ St Lucas Gent

    Ghent

    Inge Van Boxelaer

    Recruiting

  • AZ Groeninge Kortrijk

    Kortrijk, 8510

    Ellen Heyns, MD

    Recruiting

  • UZ Leuven

    Leuven

    Katrien Benhalima, MD PhD, katrien.benhalima@uzleuven.be

    Recruiting

  • CHU de Liège

    Liège

    JC Philips

    Recruiting

  • AZ St Maarten Mechelen

    Mechelen

    Kathleen Bollaerts

    Recruiting

  • AZ Oostende

    Ostend

    Linsey Winne

    Recruiting

  • Vitaz

    Sint-Niklaas

    Peter Coremans

    Recruiting

Other trials in Belgium

Australia2 sites, 2 recruiting

  • Campbelltown Hospital

    Sydney, CAMPBELLTOWN NSW, 2560

    David Simmons, Prof. Dr., +1, Da.Simmons@westernsydney.edu.au

    Recruiting

  • Royal Prince Alfred Hospital

    Sydney, Camperdown NSW, 2050

    Arianne Sweeting, Prof. Dr., +12, arianne.sweeting@sydney.edu.au

    Recruiting

Other trials in Australia

About this study

Official title: 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-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.

Read the 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.

Being tested
Freestyle Libre 3, Glucometer
Keywords
gestational diabetes, continuous glucose monitoring, early gestational diabetes
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Freestyle Libre 3Device

    CGM

  • GlucometerDevice

    SMBG

Study groups in NCT06310356
Study groupRoleWhat they receive
continuous glucose monitoringExperimentalcontinuous use of realtime-continuous glucose monitoring with Freestyle Libre 3
Receives: Device: Freestyle Libre 3
self monitoring of blood glucose with glucometerActive comparatorself 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
Receives: Device: Glucometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at delivery

Secondary outcomes (56)

  1. time in glucose range overnight between 70-95mg/dl

    time in range from 00 till 6am between 70-95mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  2. time in glucose range during the day between 70-95mg/dl

    time in range from 06 am til 00 between 70-95mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  3. time in glucose range overnight between 63-140mg/dl

    time in range from 00 till 6am between 63-140mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation

  4. time in glucoserange during the day between 63-140mg/dl

    time in range from 06 am til 00 between 63-140mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  5. time in glucose range during the day between 54-95mg/dl

    time in range from 06 am til 00 between 54-95mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  6. time in glucose range overnight between 54-95mg/dl

    time in range from 00 till 6am between 54-95mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  7. time in glucose range overnight between 63-120mg/dl

    time in range from 00 till 6am between 63-120mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  8. time in glucose range during the day between 63-120mg/dl

    time in range from 06 am til 00 between 63-120mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  9. hypoglycemia <54mg/dl

    time below 54mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  10. hypoglycemia <50mg/dl

    time below 50mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  11. hypoglycemia <63mg/dl

    time below 63mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  12. hypoglycemia <70mg/dl

    time below 70mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  13. standard deviation

    glycemic variability measured by standard deviation (SD)

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  14. Coefficient of Variance

    glycemic variability measured by coefficient of variance (CV)

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  15. mean amplitude of glycemic excursions

    glycemic variability measured by mean amplitude of glycemic excursions (MAGE)

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  16. glucose time overnight >100mg/dl

    time in range from 00 till 6am >100mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  17. glucose postprandial time >120mg/dl

    postprandial time >120mg/dl 2hours after the meal

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  18. glucose postprandial time >140mg/dl

    postprandial time >140mg/dl 1hour after the meal

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  19. glucose time >180mg/dl

    time >180mg/dl

    Measured: during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks

  20. mean HbA1c

    glycated Hb

    Measured: between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum

  21. Glucose management indicator

    Glucose management indicator, GMI

    Measured: between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum

  22. timing of start insulin treatment

    gestational age at start insulin treatment

    Measured: from GDM diagnosis till delivery

  23. mean insulin dose

    dose of short and/or long)actinbg insulin

    Measured: from GDM diagnosis till delivery

  24. mean gestational weight gain

    weight gain in pregnancy

    Measured: at delivery

  25. rate of postpartum hemorrhage

    hemorrhage with delivery

    Measured: at delivery

  26. rate of macrosomia

    birth weight >4Kg

    Measured: at delivery

  27. rate of baby >4.5Kg

    birth weight >4.5Kg

    Measured: at delivery

  28. rate of Small-for-gestational age infant

    birth weight <10Th percentile

    Measured: at delivery

  29. rate of cesarean section

    total (planned and emergency) number of cesarean sections

    Measured: at delivery

  30. rate of instrumental delivery

    delivery with forceps or vacuum

    Measured: at delivery

  31. rate of perineal inury

    3dr or 4th degree perineal laceration

    Measured: at delivery

  32. rate of labor inductions

    induction of labor

    Measured: at delivery

  33. 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

    Measured: at delivery

  34. rate of gestational hypertension

    ≥20 weeks of gestation: blood pressure ≥140/90mmHg

    Measured: at delivery

  35. rate of fetal malformation

    congenital malformation

    Measured: at delivery

  36. rate of miscarriage

    fetal loss <20 weeks gestation

    Measured: at delivery

  37. rate of polycythemia

    increased hematocrite accoridng to local practice

    Measured: at delivery

  38. rate of neonatal hypoglycemia

    bypoglycemia at birth <40mg/dl

    Measured: at delivery

  39. Treatment satisfaction

    diabetes treatment satisfaction questionnaire score, the higher the score the more satisfied, max. score of 48

    Measured: between 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum

  40. 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

    Measured: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum

  41. dietary intake

    Frequyency Food Questionnaire

    Measured: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum

  42. Physical activity

    International Physical Activity questionnaire score

    Measured: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum

  43. fear for hypoglycaemia

    the Hypoglycaemia Fear Survey II

    Measured: between 36.0-38.6 weeks

  44. fear for hyperglycaemia

    self-designed questionnaire on fear for hyperglycaemia

    Measured: between 36.0-38.6 weeks

  45. symptoms of depression

    the 20-item Center for Epidemiologic Studies-Depression (CES-D) , questionnaire, max. score 60 (the higher the more symptoms of depression)

    Measured: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum

  46. symptoms of anxiety

    validated six-item short-form STAI questionnaire on anxiety, max. score of 24 (the higher the more anxiety)

    Measured: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum

  47. user-friendliness of CGM

    self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM)

    Measured: between 36.0-38.6 weeks

  48. 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

    Measured: between 6-24 weeks postpartum

  49. duration of breastfeeding

    breastfeeding duration (exclusive or half formula) duration in months

    Measured: postpartum between 6-24 weeks

  50. rate of hypercholesterolemia

    lipid profile with LDL-cholesterol and Triglycerides

    Measured: postpartum between 6-24 weeks

  51. night glucose time in range between 70-180mg/dl

    glucose time in range between 70-180mg/dl from 00 til 6am

    Measured: postpartum between 6-24 weeks

  52. day glucose time in range between 70-180mg/dl

    glucose time in range between 70-180mg/dl from 6am till 00

    Measured: postpartum between 6-24 weeks

  53. day glucose time in range <70mg/dl

    glucose time below 70-mg/dl from 6am till 00

    Measured: postpartum between 6-24 weeks

  54. night glucose time in range <70mg/dl

    glucose time below 70-mg/dl from 00 till 6am

    Measured: postpartum between 6-24 weeks

  55. night glucose time in range >180mg/dl

    glucose time above 180mg/dl from 00 till 6am

    Measured: postpartum between 6-24 weeks

  56. day glucose time in range >180mg/dl

    glucose time above 180mg/dl from 6am till 00

    Measured: postpartum between 6-24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start18 Nov 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
386 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310356
Sponsor's protocol ID
CORDELIA
Acronym
CORDELIA
Status last verified
Apr 2026
First submitted
28 Feb 2024
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Geerts I, Yu C, Bochanen N, Heyns E, Pottelbergh IV, Morrens A, Coremans P, Philips JC, Carton T, Vandewalle S, Marlier J, Van Boxelaer I, Winne L, Bollaerts K, Lee D, Simmons D, Sweeting A, Laenen A, Mathieu C, Benhalima K. Continuous Glucose Monitoring for Women with Gestational Diabetes, CORDELIA: A Multicentric Randomized Controlled Trial, Methodology and Design. J Clin Med. 2026 Sep 29;15(19):7581. doi: 10.3390/jcm15197581.

    PubMed 42882043

Questions about this trial

What is this clinical trial studying?

A study testing Freestyle Libre 3 and Glucometer in people with Gestational Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Belgium, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katrien Benhalima, MD PhD (+3216340614, katrien.benhalima@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a composite of pregnancy outcomes (time frame: at delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06310356, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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