Continuous Glucose Monitoring for Women With Gestational Diabetes (CORDELIA)

April 28, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
386

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • UZA
        • Contact:
          • Niels Bochanen
      • Antwerp, Belgium
        • Recruiting
        • ZNA Antwerpen
        • Contact:
          • Astrid Morrens, MD
      • Bonheiden, Belgium, 2820
        • Recruiting
        • Imelda Bonheiden
        • Contact:
          • Da Hae Lee, MD
      • Bruges, Belgium, 8000
        • Recruiting
        • AZ St Jan Brugge
        • Contact:
          • Sara Vandewalle
      • Brussels, Belgium
        • Recruiting
        • Erasme
        • Contact:
          • Tiphaine Carton
      • Ghent, Belgium, 9000
        • Recruiting
        • UZ Gent
        • Contact:
          • Joke Marlier, MD
      • Ghent, Belgium
        • Recruiting
        • AZ St Lucas Gent
        • Contact:
          • Inge Van Boxelaer
      • Kortrijk, Belgium, 8510
        • Recruiting
        • AZ Groeninge Kortrijk
        • Contact:
          • Ellen Heyns, MD
      • Leuven, Belgium
      • Liège, Belgium
        • Recruiting
        • CHU de Liege
        • Contact:
          • JC Philips
      • Mechelen, Belgium
        • Recruiting
        • AZ St Maarten Mechelen
        • Contact:
          • Kathleen Bollaerts
      • Ostend, Belgium
        • Recruiting
        • AZ Oostende
        • Contact:
          • Linsey Winne
      • Sint-Niklaas, Belgium
        • Recruiting
        • Vitaz
        • Contact:
          • Peter Coremans
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 9300
        • Recruiting
        • OLV Aalst-Asse
        • Contact:
          • Inge Van Pottelbergh, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: continuous glucose monitoring
continuous use of realtime-continuous glucose monitoring with Freestyle Libre 3
Device: Freestyle Libre 3
CGM
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
Device: Glucometer
SMBG

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks of gestation
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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)
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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)
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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)
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
during 2 weeks between 20.0-23.6 weeks, 31.0-33.6 weeks, and 36.0-38.6 weeks
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
between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
timing of start insulin treatment
Time Frame: from GDM diagnosis till delivery
gestational age at start insulin treatment
from GDM diagnosis till delivery
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
between 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
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
baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
dietary intake
Time Frame: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
Frequyency Food Questionnaire
baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
Physical activity
Time Frame: baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
International Physical Activity questionnaire score
baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
fear for hypoglycaemia
Time Frame: between 36.0-38.6 weeks
the Hypoglycaemia Fear Survey II
between 36.0-38.6 weeks
fear for hyperglycaemia
Time Frame: between 36.0-38.6 weeks
self-designed questionnaire on fear for hyperglycaemia
between 36.0-38.6 weeks
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)
baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
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)
baseline, between 36.0-38.6 weeks and 6-24 weeks postpartum
user-friendliness of CGM
Time Frame: between 36.0-38.6 weeks
self-designed questionnaire on the user-friendliness of continuous glucose monitoring (CGM)
between 36.0-38.6 weeks
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
between 6-24 weeks postpartum
duration of breastfeeding
Time Frame: postpartum between 6-24 weeks
breastfeeding duration (exclusive or half formula) duration in months
postpartum between 6-24 weeks
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
postpartum between 6-24 weeks
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
postpartum between 6-24 weeks
day glucose time in range <70mg/dl
Time Frame: postpartum between 6-24 weeks
glucose time below 70-mg/dl from 6am till 00
postpartum between 6-24 weeks
night glucose time in range <70mg/dl
Time Frame: postpartum between 6-24 weeks
glucose time below 70-mg/dl from 00 till 6am
postpartum between 6-24 weeks
night glucose time in range >180mg/dl
Time Frame: postpartum between 6-24 weeks
glucose time above 180mg/dl from 00 till 6am
postpartum between 6-24 weeks
day glucose time in range >180mg/dl
Time Frame: postpartum between 6-24 weeks
glucose time above 180mg/dl from 6am till 00
postpartum between 6-24 weeks
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
between 20.0-23.6 weeks, 31.0-33.6 weeks, 36.0-38.6 weeks and 6-24 weeks postpartum
mean insulin dose
Time Frame: from GDM diagnosis till delivery
dose of short and/or long)actinbg insulin
from GDM diagnosis till delivery
mean gestational weight gain
Time Frame: at delivery
weight gain in pregnancy
at delivery
rate of postpartum hemorrhage
Time Frame: at delivery
hemorrhage with delivery
at delivery
rate of macrosomia
Time Frame: at delivery
birth weight >4Kg
at delivery
rate of baby >4.5Kg
Time Frame: at delivery
birth weight >4.5Kg
at delivery
rate of Small-for-gestational age infant
Time Frame: at delivery
birth weight <10Th percentile
at delivery
rate of cesarean section
Time Frame: at delivery
total (planned and emergency) number of cesarean sections
at delivery
rate of instrumental delivery
Time Frame: at delivery
delivery with forceps or vacuum
at delivery
rate of perineal inury
Time Frame: at delivery
3dr or 4th degree perineal laceration
at delivery
rate of labor inductions
Time Frame: at delivery
induction of labor
at delivery
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
at delivery
rate of gestational hypertension
Time Frame: at delivery
≥20 weeks of gestation: blood pressure ≥140/90mmHg
at delivery
rate of fetal malformation
Time Frame: at delivery
congenital malformation
at delivery
rate of miscarriage
Time Frame: at delivery
fetal loss <20 weeks gestation
at delivery
rate of polycythemia
Time Frame: at delivery
increased hematocrite accoridng to local practice
at delivery
rate of neonatal hypoglycemia
Time Frame: at delivery
bypoglycemia at birth <40mg/dl
at delivery
rate of hypercholesterolemia
Time Frame: postpartum between 6-24 weeks
lipid profile with LDL-cholesterol and Triglycerides
postpartum between 6-24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Ghent
University Hospital, Antwerp
Imelda Hospital, Bonheiden
Onze Lieve Vrouw Hospital
General Hospital Groeninge
Ziekenhuis Netwerk Antwerpen (ZNA)
Université Catholique de Louvain
AZ Sint-Lucas Gent
Erasme University Hospital
AZ Sint-Lucas Brugge
Centre Hospitalier Universitaire de Liege
Vitaz
AZ St Maarten Mechelen
AZ Oostende

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CORDELIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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