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

NCT ID: NCT06874907

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-07-01

Brief 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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Continuous glucose monitoring

First trimester prediction of gestational diabetes mellitus by continuous glucose monitoring

Glucose monitoring

Intervention Type: PROCEDURE

Glucose monitoring

Interventions

Glucose monitoring

Glucose monitoring

Intervention Type: PROCEDURE

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:

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catalina de Paco Matallana, MD

Role: PRINCIPAL_INVESTIGATOR

HCUVA

Locations

HCUVA

El Palmar, Murcia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Catalina de Paco Matallana, MD

Role: CONTACT

katy.depaco@gmail.com

968369500

Other Identifiers

IMIB-GLC-2023-03

Identifier Type: -

Identifier Source: org_study_id