First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring. (GLUCO-GCM)

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Procedure: Glucose monitoring

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Catalina de Paco Matallana, MD; Phone Number: 968369500; Email: katy.depaco@gmail.com

Study Locations

• Spain
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Recruiting
      • HCUVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pregnant patients over 18 years of age

Description

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:

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Continuous glucose monitoring; First trimester prediction of gestational diabetes mellitus by continuous glucose monitoring	Procedure: Glucose monitoring; Glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus )	GDM is defined by abnormal results of 75mg OGTT(Oral Glucose Tolerance Test) at 28 weeks' gestation	Up to 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Gestational hypertension	blood pressure readings are higher than 140/90 mm Hg in a woman who had normal blood pressure prior to 20 weeks and has no proteinuria (excess protein in the urine)	Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks	Number of patients with Delivery by caesarean section	Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks	Number of patients with Stillbirth, neonatal death, perinatal death	Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks	Number of patients with Large for gestational age neonate (>90th and 95th percentile for gestation)	Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks	Number of patients with Neonatal hyperglycaemia	Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks	Number of patients with Neonatal hyperbilirubinemia	Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks	Number of patients with Neonatal unit (NNU) admission for ≥48 hours	Up to 28 weeks
Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks	Number of days (Length of stay) in the Neonatal Intensive Unit.	Up to 28 weeks

Collaborators and Investigators

• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Collaborators: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Catalina de Paco Matallana, MD, HCUVA

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus; Pregnancy in Diabetics
• Other Study ID Numbers: IMIB-GLC-2023-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No