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NCT Number: NCT06874907

First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

HCUVA

El Palmar, Murcia, 30120, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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:

Treatment and study plan

Glucose monitoring

Procedure

Glucose monitoring

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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.

Study contacts

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

Catalina de Paco Matallana, MD

CONTACT

[email protected]

968369500

Sponsors and collaborators

Lead sponsor

Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Other

Collaborators

  • King's College Hospital NHS Trust

Registry information

Acronym: GLUCO-GCM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

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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