Actively Recruiting
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring
Led by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Updated on 2025-03-13
1000
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
F
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Lead Sponsor
K
King's College Hospital NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gestational diabetes mellitus (GDM) is a common pregnancy complication affecting 10-15% of pregnancies and linked to short- and long-term health risks for both mother and baby. As maternal age and weight increase, so does the incidence of GDM, which is traditionally diagnosed later in pregnancy using an oral glucose tolerance test (OGTT). Early detection could help manage risks like macrosomia, neonatal hypoglycemia, and maternal complications including hypertensive disorders and cesarean delivery. This observational study evaluates the use of continuous glucose monitoring (CGM) during the first trimester to predict GDM, comparing CGM results at 12 and 28 weeks of pregnancy with the standard OGTT at 28 weeks. Participants will wear a CGM device to track glucose levels continuously, aiming to identify early signs of GDM. No treatment interventions are applied, as the study focuses on monitoring and prediction in pregnant women. Participants will undergo CGM at 12 and 28 weeks of gestation, alongside routine OGTT testing at 28 weeks. Researchers will assess glucose profiles to evaluate CGM’s predictive value for GDM. The study also tracks the occurrence of gestational hypertension. Participants will be monitored up to 28 weeks, with data collected on glucose patterns and pregnancy outcomes. The total participation period lasts until the 28th week of gestation.
CONDITIONS
Brief Title
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age 18 years or older
- Planned antenatal care at the same centre (not planning to move before delivery)
- Singleton pregnancy
- Provided informed and written consent
You will not qualify if you...
- Age under 18 years
- Multiple pregnancy in current pregnancy
- Unconscious or very ill
- Serious mental illness
- Learning difficulties
- Not fluent in local language without interpreter
- Severe congenital anomaly on ultrasound
- Pre-existing type 1 or type 2 diabetes mellitus
- Undergoing metformin therapy for infertility
- Significant pre-pregnancy comorbidities increasing pregnancy risk (e.g., renal failure, severe liver disease, transplantation, cardiac failure, recent psychiatric inpatient admission)
- Significant co-morbidity in current pregnancy (e.g., nephropathy with eGFR <60ml/min)
- Other physical or psychological conditions likely to interfere with the study or results
- Participation in another intervention study influencing outcomes
- Allergy to adhesive materials
- Allergy to any components of the glucose test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 weeks
Participants undergo continuous glucose monitoring during pregnancy to predict gestational diabetes mellitus.
Visits at 12 and 28 weeks of gestation
Trial Site Locations
Total: 1 location
1
HCUVA
El Palmar, Murcia, Spain, 30120
Actively Recruiting
Research Team
C
Catalina de Paco Matallana, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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