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

Launched by FUNDACION PARA LA FORMACION E INVESTIGACION SANITARIAS DE LA REGION DE MURCIA · Mar 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to predict gestational diabetes mellitus (GDM) early in pregnancy using a device that continuously monitors blood sugar levels. GDM is a common condition that can occur during pregnancy and can lead to complications for both the mother and the baby if not managed properly. Currently, most women are tested for GDM later in their pregnancy, around 26-28 weeks, but this trial aims to see if early detection can help improve outcomes.

To participate in this study, women must be at least 18 years old, be planning to receive their prenatal care at the same location, and be expecting only one baby. Women who have certain medical conditions, like pre-existing diabetes or serious mental health issues, or those who are not able to communicate effectively, may not be eligible. If chosen to participate, women will wear a continuous glucose monitor, which tracks their blood sugar levels throughout the day, helping researchers find out if this method can identify GDM sooner and improve care for both mothers and their babies.

Gender

FEMALE

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: