Clinical trial NCT06874907: First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
Official title: First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes Mellitus in Pregnancy
Lead sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2025-03-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients over 18 years of age

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.


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:

Primary outcomes:
measure: Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus )
timeFrame: Up to 28 weeks
Secondary outcomes:
measure: Number of patients with Gestational hypertension
timeFrame: Up to 28 weeks
measure: Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
timeFrame: Up to 28 weeks
measure: Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
timeFrame: Up to 28 weeks
measure: Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
timeFrame: Up to 28 weeks
measure: Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
timeFrame: Up to 28 weeks
measure: Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
timeFrame: Up to 28 weeks
measure: Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
timeFrame: Up to 28 weeks
measure: Glycaemic profile according to CGM (Continuous glucose monitoring)at 12 and 28 weeks and OGTT(Gestational diabetes mellitus ) results at 28 weeks
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: El Palmar
country: Spain
facility: HCUVA
state: Murcia
Study officials:
affiliation: HCUVA
name: Catalina de Paco Matallana, MD
role: PRINCIPAL_INVESTIGATOR
References: