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

Last updated: March 10, 2025
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Glucose monitoring

Clinical Study ID

NCT06874907
IMIB-GLC-2023-03
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Maternal age ≥ 18 years

  • Planned antenatal care at the same centre (i.e. not planning to move beforedelivery).

  • Singleton pregnancy.

  • Informed and written consent.

Exclusion

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, forexample 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 withthe conduct of the study and/or interpretation of the trial results;

  • Participating in another intervention study that influences outcomes of thisstudy;

  • Allergy to adhesive materials;

  • Allergy to any of the components of the glucose test:

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Glucose monitoring
Phase:
Study Start date:
March 01, 2025
Estimated Completion Date:
July 01, 2026

Connect with a study center

  • HCUVA

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

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