Predicting gestational diabetes in early pregnancy using continuous glucose monitoring.

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

This study is testing if using continuous glucose monitoring in early pregnancy can help identify women at risk for gestational diabetes sooner than usual.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia (Academic / other)
• Locations: 1 site (El Palmar, Murcia)
• Trial ID: NCT06874907 on ClinicalTrials.gov

What this trial studies

This observational study aims to predict gestational diabetes mellitus (GDM) in pregnant women during the first trimester by utilizing continuous glucose monitoring. GDM is a common complication of pregnancy that can lead to various maternal and neonatal health issues. The study will involve monitoring glucose levels in women who meet specific eligibility criteria, including being at least 18 years old and having a singleton pregnancy. The goal is to identify women at risk for GDM earlier than the traditional screening methods, which typically occur later in pregnancy.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18 and older who are planning to receive antenatal care at the same center.

Not a fit: Patients who may not benefit from this study include those under 18 years old, those with multiple pregnancies, or those with pre-existing diabetes.

Why it matters

Potential benefit: If successful, this approach could lead to earlier detection and management of gestational diabetes, potentially reducing complications for both mothers and infants.

How similar studies have performed: While the approach of using continuous glucose monitoring for early prediction of GDM is innovative, similar studies have not been widely reported, indicating this may be a novel approach.

Eligibility criteria

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:

Where this trial is running

El Palmar, Murcia

• Hcuva — El Palmar, Murcia, Spain (Recruiting)

Study contacts

• Principal investigator: Catalina de Paco Matallana, MD — Hcuva
• Study coordinator: Catalina de Paco Matallana, MD

Conditions Gestational Diabetes Mellitus in Pregnancy