Gestational Diabetes Mellitus in PregnancyGLUCO-GCMNCT06874907
First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
An observational study of Gestational Diabetes Mellitus in Pregnancy, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Glucose monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2025to 1 Jul 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant patients over 18 years of age
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose monitoringProcedure or surgery
Glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring | First trimester prediction of gestational diabetes mellitus by continuous glucose monitoring Receives: Procedure: Glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 28 weeks
Secondary outcomes (8)
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Catalina de Paco Matallana, MD, Principal investigator, HCUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874907
- Sponsor's protocol ID
- IMIB-GLC-2023-03
- Acronym
- GLUCO-GCM
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Trimester Prediction of Gestational Diabetes Mellitus by Continuous Glucose Monitoring.
- ClinicalTrials.gov ID
- NCT06874907
- Acronym / sponsor ID
- GLUCO-GCM / IMIB-GLC-2023-03
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fundacion para la Formacion e Investigacion Sanitarias de la Region de MurciaUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | – | Procedure: Glucose monitoringFirst trimester prediction of gestational diabetes mellitus by continuous glucose monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients over 18 years of age
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Age <18 years;
- Multiple pregnancy in current pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose monitoringGlucose monitoring | Procedure or surgery | Continuous glucose monitoring |
Primary outcome
Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus )
Time frame: Up to 28 weeks
GDM is defined by abnormal results of 75mg OGTT(Oral Glucose Tolerance Test) at 28 weeks' gestation
8 secondary outcomes
Number of patients with Gestational hypertension
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Related trials for Gestational Diabetes Mellitus in Pregnancy
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catalina de Paco Matallana, MD principal investigator
HCUVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus in Pregnancy, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catalina de Paco Matallana, MD (968369500, katy.depaco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of CGM (Continuous glucose monitoring) at 12 and 28 weeks of gestation in the prediction of GDM (Gestational diabetes mellitus ) (time frame: Up to 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.