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NCT Number: NCT06310356

Continuous Glucose Monitoring for Women With Gestational Diabetes

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Campbelltown Hospital, Sydney, CAMPBELLTOWN NSW, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FreeStyle Libre 3

Device

CGM

Glucometer

Device

SMBG

Primary outcomes

  1. a composite of pregnancy outcomes

    Time frame: at delivery

    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

Secondary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  9. hypoglycemia <54mg/dl

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

    time below 54mg/dl

  10. hypoglycemia <50mg/dl

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

    time below 50mg/dl

  11. hypoglycemia <63mg/dl

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

    time below 63mg/dl

  12. hypoglycemia <70mg/dl

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

    time below 70mg/dl

  13. standard deviation

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

    glycemic variability measured by standard deviation (SD)

  14. Coefficient of Variance

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

    glycemic variability measured by coefficient of variance (CV)

  15. mean amplitude of glycemic excursions

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

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

  16. glucose time overnight >100mg/dl

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

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

  17. glucose postprandial time >120mg/dl

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

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

  18. glucose postprandial time >140mg/dl

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

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

  19. glucose time >180mg/dl

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

    time >180mg/dl

  20. mean HbA1c

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

    glycated Hb

  21. Glucose management indicator

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

    Glucose management indicator, GMI

  22. timing of start insulin treatment

    Time frame: from GDM diagnosis till delivery

    gestational age at start insulin treatment

  23. mean insulin dose

    Time frame: from GDM diagnosis till delivery

    dose of short and/or long)actinbg insulin

  24. mean gestational weight gain

    Time frame: at delivery

    weight gain in pregnancy

  25. rate of postpartum hemorrhage

    Time frame: at delivery

    hemorrhage with delivery

  26. rate of macrosomia

    Time frame: at delivery

    birth weight >4Kg

  27. rate of baby >4.5Kg

    Time frame: at delivery

    birth weight >4.5Kg

  28. rate of Small-for-gestational age infant

    Time frame: at delivery

    birth weight <10Th percentile

  29. rate of cesarean section

    Time frame: at delivery

    total (planned and emergency) number of cesarean sections

  30. rate of instrumental delivery

    Time frame: at delivery

    delivery with forceps or vacuum

  31. rate of perineal inury

    Time frame: at delivery

    3dr or 4th degree perineal laceration

  32. rate of labor inductions

    Time frame: at delivery

    induction of labor

  33. rate of preeclamspia

    Time frame: at delivery

    [≥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

  34. rate of gestational hypertension

    Time frame: at delivery

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

  35. rate of fetal malformation

    Time frame: at delivery

    congenital malformation

  36. rate of miscarriage

    Time frame: at delivery

    fetal loss <20 weeks gestation

  37. rate of polycythemia

    Time frame: at delivery

    increased hematocrite accoridng to local practice

  38. rate of neonatal hypoglycemia

    Time frame: at delivery

    bypoglycemia at birth <40mg/dl

  39. Treatment satisfaction

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

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

  40. Quality of life based on Short Form (SF-36) score

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

    Short Form (SF-36) score, the higher the score the higher the Quality of life with a max score of 100

  41. dietary intake

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

    Frequyency Food Questionnaire

  42. Physical activity

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

    International Physical Activity questionnaire score

  43. fear for hypoglycaemia

    Time frame: between 36.0-38.6 weeks

    the Hypoglycaemia Fear Survey II

  44. fear for hyperglycaemia

    Time frame: between 36.0-38.6 weeks

    self-designed questionnaire on fear for hyperglycaemia

  45. symptoms of depression

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

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

  46. symptoms of anxiety

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

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

  47. user-friendliness of CGM

    Time frame: between 36.0-38.6 weeks

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

  48. user-friendliness of CGM compared to oral glucose tolerance test (OGTT)

    Time frame: between 6-24 weeks postpartum

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

  49. duration of breastfeeding

    Time frame: postpartum between 6-24 weeks

    breastfeeding duration (exclusive or half formula) duration in months

  50. rate of hypercholesterolemia

    Time frame: postpartum between 6-24 weeks

    lipid profile with LDL-cholesterol and Triglycerides

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

    Time frame: postpartum between 6-24 weeks

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

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

    Time frame: postpartum between 6-24 weeks

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

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

    Time frame: postpartum between 6-24 weeks

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

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

    Time frame: postpartum between 6-24 weeks

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

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

    Time frame: postpartum between 6-24 weeks

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

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

    Time frame: postpartum between 6-24 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Katrien Benhalima, MD PhD

CONTACT

[email protected]

+3216340614

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • AZ Oostende
  • AZ Sint-Lucas Brugge
  • AZ Sint-Lucas Gent
  • AZ St Maarten Mechelen
  • Campbelltown Hospital/SWSLHD
  • Centre Hospitalier Universitaire de Liege
  • Erasme University Hospital
  • General Hospital Groeninge
  • Imelda Hospital, Bonheiden
  • Onze Lieve Vrouw Hospital
  • Royal Prince Alfred Hospital, Sydney, Australia
  • University Hospital, Antwerp
  • University Hospital, Ghent
  • Université Catholique de Louvain
  • Vitaz
  • Ziekenhuis Netwerk Antwerpen (ZNA)

Registry information

Official study title

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

Acronym: CORDELIA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 15, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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