Neonatal HypoglycemiaCOMET-GDMNCT07462793
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus
A study testing Dexcom ONE Continuous Glucose Monitoring System in people with Neonatal Hypoglycemia and Gestational Diabetes Mellitus (GDM), run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes. Read more about this study
- Who is it for?
- Ages 1 minute to 30 minutesHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypoglycemia, Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Dexcom ONE Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2026to Dec 2027
- Phase
- Interventional
- 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 1 minute to 30 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Maternal age of 18 years or older
- Singleton pregnancy
- Insulin-treated gestational diabetes mellitus
Who cannot join
- Multifetal pregnancy
- Congenital malformations or metabolic defects in the newborn
- Preterm birth (defined as birth <37 weeks of gestation)
- Smoking during pregnancy
- Preeclampsia, fetal growth restriction
- Perinatal asphyxia
- Congenital infections in the newborn
- Adverse skin reactions (eczema, wounds) in the planned sensor insertion area
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Institute of Mother and Child
Warsaw, 01-211
Aleksandra H Symonides-Pomianek, +48 22 32 77 406, aleksandra.symonides@imid.med.pl
Paweł Krajewski, MD, PhD, Assoc. Prof., +48 22 32 77 406, pawel.krajewski@imid.med.pl
About this study
Official title: COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.
Read the detailed description
Gestational diabetes mellitus (GDM) is a form of glucose intolerance affecting up to 14% of pregnant women and is associated with an increased risk of multiple maternal and fetal complications. This risk is proportional to the degree of maternal hyperglycaemia. Appropriate glycaemic control and dietary management are key components of GDM treatment. However, in approximately 10-30% of cases, pharmacological therapy is required, due to persistent fasting hyperglycaemia.
Neonatal hypoglycaemia is one of the most common metabolic complications associated with GDM, affecting approximately 5-15% of newborns, and is linked to increased morbidity. There is currently no universal consensus regarding the lowest safe blood glucose threshold required to prevent neurological complications in this population. Nevertheless, persistent or recurrent hypoglycaemia, that is unresponsive to treatment is known to be associated with adverse neurological outcomes.
Following birth and umbilical cord clamping, the newborn must maintain glucose homeostasis through endogenous production via glycogenolysis and gluconeogenesis, as well as through enteral feeding. This physiological transition results in lower blood glucose concentrations during the first 4 hours of life and increases the risk of neonatal hypoglycaemia. Furthermore, in pregnancies complicated by insulin-treated GDM, chronic maternal hyperglycaemia leads to hypertrophy of the fetal pancreatic islets and fetal hyperinsulinaemia, which further increases the risk of hypoglycaemia after birth.
Current clinical guidelines rely on intermittent capillary blood glucose measurements performed at predetermined intervals. However, this scheduled testing approach may fail to detect transient hypoglycaemic episodes.
Continuous glucose monitoring (CGM) enables continuous measurement of interstitial glucose concentrations. Despite its potential advantages, there is limited evidence regarding the clinical significance of CGM use in neonates born to mothers with insulin-treated gestational diabetes.
The aim of this study is to determine whether CGM improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes. This study is designed as a single-centre, randomised controlled trial conducted at the Department of Neonatology and Neonatal Intensive Care, Institute of Mother and Child, Warsaw, Poland.
In the intervention group (CGM group), glucose concentrations will be monitored using CGM. Routine scheduled capillary blood glucose measurements will not be performed unless clinically indicated.
In the control group (standard monitoring group), glucose concentrations will be measured using capillary blood glucose testing in accordance with the local standard protocol. A CGM sensor will also be applied; however, glucose recordings will be masked to both clinical staff and parents.
In both groups, CGM will continuously collect glucose data for the first 72 hours after birth.
- Being tested
- Dexcom ONE Continuous Glucose Monitoring System
- Keywords
- gestational diabetes mellitus, neonatal hypoglycemia, insulin-treated gestational diabetes, neurodevelopmental outcomes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom ONE Continuous Glucose Monitoring SystemDevice
The Dexcom ONE continuous glucose monitoring system is applied to all participants. Following randomisation, CGM data are either available in real time to the clinical team (intervention group) or recorded in masked mode and not available to the clinical team, and therefore do not influence clinical management (control group).
| Study group | Role | What they receive |
|---|---|---|
| Continuous glucose monitoring | Experimental | Neonates undergo continuous glucose monitoring (CGM), with real-time glucose values visible to the clinical team. CGM data may be used to support the detection and clinical management of neonatal hypoglycaemia in accordance with the study protocol. Receives: Device: Dexcom ONE Continuous Glucose Monitoring System |
| Blood glucose testing based on standard care procedures | Active comparator | Detection and management of neonatal hypoglycaemia are based on standard care procedures, as defined by the local protocol. Additionally, neonates undergo continuous glucose monitoring (CGM) in masked mode. CGM values are not visible to the clinical team and do not guide clinical decision-making. Receives: Device: Dexcom ONE Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal hypoglycaemia
Number of hypoglycaemic episodes per neonate, defined as the number of CGM-recorded glucose values <40mg/dl (2.2 mmol/L) occuring within the first 72 hours after birth.
Measured: From birth until 72 hours of life
Secondary outcomes (6)
Total cumulative duration of hypoglycaemia per neonate within the first 72 hours of life
Total cumulative duration of hypoglycaemia per neonate within the first 72 hours of life, defined as the sum of all time periods during which CGM-measured glucose concentration is <40 mg/dL (2.2 mmol/L), expressed in minutes.
Measured: From birth until 72 hours of life
Number of hypoglycaemia-related clinical interventions per neonate during the monitoring period
Number of clinical interventions (feeding, oral glucose, intravenous glucose administration) per neonate during the monitoring period due to hypoglycaemia
Measured: From birth until 72 hours of life
Number of capillary blood glucose measurements per neonate
Number of capillary blood glucose measurements per neonate during the monitoring period in the control group.
Measured: From birth until 72 hours of life
Measures of glucose variability per neonate within the first 72 hours of life
Glucose variability metrics derived from CGM data, including:
- standard deviation (SD) of glucose concentration, and
- coefficient of variation (CV), calculated as SD divided by mean glucose and expressed as a percentage.
Measured: First 72 hours after birth
Percentage of time with glucose <40 mg/dL
Percentage of time with glucose <40 mg/dL (2.2 mmol/L) per neonate within the first 72 hours after birth
Measured: From birth until 72 hours of life
Proportion of neonates by feeding type at hospital discharge
Proportion of neonates receiving exclusive breastfeeding, mixed feeding (breast milk and formula), or exclusive formula feeding at the time of hospital discharge.
Measured: At the time of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypoglycemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Mother and Child, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Aleksandra Symonides-Pomianek, Institute of Mother and Child, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462793
- Sponsor's protocol ID
- 42/2025
- Other IDs
- 42/2025
- Acronym
- COMET-GDM
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07462793
- Acronym / sponsor ID
- COMET-GDM / 42/2025
- Keywords
- gestational diabetes mellitus, neonatal hypoglycemia, insulin-treated gestational diabetes, neurodevelopmental outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute of Mother and Child, Warsaw, PolandUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.
Detailed description
Gestational diabetes mellitus (GDM) is a form of glucose intolerance affecting up to 14% of pregnant women and is associated with an increased risk of multiple maternal and fetal complications. This risk is proportional to the degree of maternal hyperglycaemia. Appropriate glycaemic control and dietary management are key components of GDM treatment. However, in approximately 10-30% of cases, pharmacological therapy is required, due to persistent fasting hyperglycaemia.
Neonatal hypoglycaemia is one of the most common metabolic complications associated with GDM, affecting approximately 5-15% of newborns, and is linked to increased morbidity. There is currently no universal consensus regarding the lowest safe blood glucose threshold required to prevent neurological complications in this population. Nevertheless, persistent or recurrent hypoglycaemia, that is unresponsive to treatment is known to be associated with adverse neurological outcomes.
Following birth and umbilical cord clamping, the newborn must maintain glucose homeostasis through endogenous production via glycogenolysis and gluconeogenesis, as well as through enteral feeding. This physiological transition results in lower blood glucose concentrations during the first 4 hours of life and increases the risk of neonatal hypoglycaemia. Furthermore, in pregnancies complicated by insulin-treated GDM, chronic maternal hyperglycaemia leads to hypertrophy of the fetal pancreatic islets and fetal hyperinsulinaemia, which further increases the risk of hypoglycaemia after birth.
Current clinical guidelines rely on intermittent capillary blood glucose measurements performed at predetermined intervals. However, this scheduled testing approach may fail to detect transient hypoglycaemic episodes.
Continuous glucose monitoring (CGM) enables continuous measurement of interstitial glucose concentrations. Despite its potential advantages, there is limited evidence regarding the clinical significance of CGM use in neonates born to mothers with insulin-treated gestational diabetes.
The aim of this study is to determine whether CGM improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes. This study is designed as a single-centre, randomised controlled trial conducted at the Department of Neonatology and Neonatal Intensive Care, Institute of Mother and Child, Warsaw, Poland.
In the intervention group (CGM group), glucose concentrations will be monitored using CGM. Routine scheduled capillary blood glucose measurements will not be performed unless clinically indicated.
In the control group (standard monitoring group), glucose concentrations will be measured using capillary blood glucose testing in accordance with the local standard protocol. A CGM sensor will also be applied; however, glucose recordings will be masked to both clinical staff and parents.
In both groups, CGM will continuously collect glucose data for the first 72 hours after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous glucose monitoring | Experimental | Device: Dexcom ONE Continuous Glucose Monitoring SystemNeonates undergo continuous glucose monitoring (CGM), with real-time glucose values visible to the clinical team. CGM data may be used to support the detection and clinical management of neonatal hypoglycaemia in accordance with the study protocol. |
| Blood glucose testing based on standard care procedures | Active comparator | Device: Dexcom ONE Continuous Glucose Monitoring SystemDetection and management of neonatal hypoglycaemia are based on standard care procedures, as defined by the local protocol. Additionally, neonates undergo continuous glucose monitoring (CGM) in masked mode. CGM values are not visible to the clinical team and do not guide clinical decision-making. |
Who may qualify
- Ages
- 1 minute to 30 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Maternal age of 18 years or older
- Singleton pregnancy
- Insulin-treated gestational diabetes mellitus
Key exclusion criteria (8 listed)
- Multifetal pregnancy
- Congenital malformations or metabolic defects in the newborn
- Preterm birth (defined as birth <37 weeks of gestation)
- Smoking during pregnancy
- Preeclampsia, fetal growth restriction
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 |
|---|---|---|
| Dexcom ONE Continuous Glucose Monitoring SystemThe Dexcom ONE continuous glucose monitoring system is applied to all participants. Following randomisation, CGM data are either available in real time to the clinical team (intervention group) or recorded in masked mode and not available to the clinical team, and therefore do not influence clinical management (control group). | Device | Blood glucose testing based on standard care procedures, Continuous glucose monitoring |
Primary outcome
Neonatal hypoglycaemia
Time frame: From birth until 72 hours of life
Number of hypoglycaemic episodes per neonate, defined as the number of CGM-recorded glucose values <40mg/dl (2.2 mmol/L) occuring within the first 72 hours after birth.
6 secondary outcomes
Total cumulative duration of hypoglycaemia per neonate within the first 72 hours of life
Time frame: From birth until 72 hours of life
Number of hypoglycaemia-related clinical interventions per neonate during the monitoring period
Time frame: From birth until 72 hours of life
Number of capillary blood glucose measurements per neonate
Time frame: From birth until 72 hours of life
Measures of glucose variability per neonate within the first 72 hours of life
Time frame: First 72 hours after birth
Percentage of time with glucose <40 mg/dL
Time frame: From birth until 72 hours of life
Proportion of neonates by feeding type at hospital discharge
Time frame: At the time of hospital discharge
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 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom ONE Continuous Glucose Monitoring System in people with Neonatal Hypoglycemia and Gestational Diabetes Mellitus (GDM), run by Institute of Mother and Child, Warsaw, Poland at 1 site in Poland.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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 Poland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal hypoglycaemia (time frame: From birth until 72 hours of life). 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 10 Mar 2026.