First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring. (GLUCO-GCM)

March 10, 2025 updated by: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Gestational diabetes mellitus (GDM) is the most common complication of pregnancy, with an incidence rate of 10-15% [1]. Common risk factors for GDM are increased maternal age and weight and as a consequence of women delaying childbirth and increasing incidence of obesity, there is a corresponding increase in the rate of GDM. GDM is associated with an increased risk of maternal and perinatal short and long-term complications . These include macrosomia, shoulder dystocia, neonatal hypoglycaemia, neonatal hyperbilirubinemia, and perinatal mortality. Maternal complications include higher risks of hypertensive disorders, perineal trauma, and caesarean section. Additionally, both the mothers with GDM and their infants have an increased risk of developing type 2 diabetes mellitus and cardiovascular disease later in life .

Screening and diagnosis of GDM is currently based on an oral glucose tolerance (OGTT), which is carried out at 26-28 weeks' gestation. In addition, an OGTT is carried out at 11-13 weeks in women considered to be at increased risk of GDM based on their demographic characteristics and medical history. Screening and diagnosis of GDM is traditionally delayed until the late second or early third trimester of pregnancy with the rationale that the diabetogenic effects of pregnancy increase with gestation and therefore delayed testing would maximize the detection rate.

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.

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.
Observational

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.
1000

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

  • Spain
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • HCUVA

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

Sampling Method

Probability Sample

Study Population

Pregnant patients over 18 years of age

Description

Inclusion Criteria:

  • Maternal age ≥ 18 years
  • Planned antenatal care at the same centre (i.e. not planning to move before delivery).
  • Singleton pregnancy.
  • Informed and written consent.

Exclusion Criteria:

  • Age <18 years;

  • Multiple pregnancy in current pregnancy;

    • Unconscious or very ill; · Serious mental illness;
    • Learning difficulties;
    • Not fluent in local language and absence of interpreter;
    • Severe congenital anomaly on ultrasound;
    • Pre-existing diabetes mellitus type 1 or 2;
    • Patients undergoing metformin therapy for infertility.
    • Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (<1 year);
    • Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR <60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results;
    • Participating in another intervention study that influences outcomes of this study;
    • Allergy to adhesive materials;
    • Allergy to any of the components of the glucose test:

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Continuous glucose monitoring
First trimester prediction of gestational diabetes mellitus by continuous glucose monitoring
Procedure: Glucose monitoring
Glucose monitoring

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
Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus )
Time Frame: Up to 28 weeks
GDM is defined by abnormal results of 75mg OGTT(Oral Glucose Tolerance Test) at 28 weeks' gestation
Up to 28 weeks

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
Number of patients with Gestational hypertension
Time Frame: Up to 28 weeks
blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has no proteinuria (excess protein in the urine)
Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Time Frame: Up to 28 weeks
Number of patients with Delivery by caesarean section
Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Time Frame: Up to 28 weeks
Number of patients with Stillbirth, neonatal death, perinatal death
Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Time Frame: Up to 28 weeks
Number of patients with Large for gestational age neonate (>90th and 95th percentile for gestation)
Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Time Frame: Up to 28 weeks
Number of patients with Neonatal hyperglycaemia
Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Time Frame: Up to 28 weeks
Number of patients with Neonatal hyperbilirubinemia
Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Time Frame: Up to 28 weeks
Number of patients with Neonatal unit (NNU) admission for ≥48 hours
Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
Time Frame: Up to 28 weeks
Number of days (Length of stay) in the Neonatal Intensive Unit.
Up to 28 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.
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

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.
King's College Hospital NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catalina de Paco Matallana, MD, HCUVA

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.
March 1, 2025

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.
March 1, 2026

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.
July 1, 2026

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).
March 4, 2025

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 10, 2025

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 25, 2025

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.
March 25, 2025

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.
March 10, 2025

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.
March 1, 2025

More Information

Terms related to this study

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.
  • IMIB-GLC-2023-03

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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