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RecruitingNCT06874907GLUCO-GCMUpdated Mar 13, 2025

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

An observational study in Gestational Diabetes Mellitus in Pregnancy, sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Gestational Diabetes Mellitus in Pregnancy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pregnant patients over 18 years of age

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

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:
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Continuous glucose monitoring

    First trimester prediction of gestational diabetes mellitus by continuous glucose monitoring

    Procedure: Glucose monitoring

Interventions

  • ProcedureGlucose monitoring

    Glucose monitoring

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 28 weeks

Secondary outcomes

  1. 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)

    Time frame: Up to 28 weeks

  2. 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

    Time frame: Up to 28 weeks

  3. 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

    Time frame: Up to 28 weeks

  4. 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)

    Time frame: Up to 28 weeks

  5. 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

    Time frame: Up to 28 weeks

  6. 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

    Time frame: Up to 28 weeks

  7. 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

    Time frame: Up to 28 weeks

  8. 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.

    Time frame: Up to 28 weeks

06

Study locations

1 of 1 sites recruiting
  • HCUVA
    El Palmar, Murcia 30120, Spain
    Recruiting
07

Registry details

Key details

Study ID
NCT06874907
Lead sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators
King's College Hospital NHS Trust
Responsible party
Sponsor
First posted
Mar 13, 2025
Start date
Mar 1, 2025
Primary completion
Mar 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Mar 13, 2025

Study contacts

Catalina de Paco Matallana, MD
Contact
katy.depaco@gmail.com
968369500
Catalina de Paco Matallana, MD
principal investigator · HCUVA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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