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Clinical Trial NCT07462793 (COMET-GDM) for Neonatal Hypoglycemia, Gestational Diabetes Mellitus (GDM) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM) 120
Clinical Trial NCT07462793 (COMET-GDM) is an interventional study for Neonatal Hypoglycemia, Gestational Diabetes Mellitus (GDM) and is currently not yet recruiting. Enrollment is planned to begin on March 1, 2026 and continue until the study accrues 120 participants. Led by Institute of Mother and Child, Warsaw, Poland, this study is expected to complete by December 1, 2027. The latest data from ClinicalTrials.gov was last updated on March 10, 2026.
Brief 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.
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 i...Show More
Official Title
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
Conditions
Neonatal HypoglycemiaGestational Diabetes Mellitus (GDM)Other Study IDs
- COMET-GDM
- 42/2025
- 42/2025 (Other Identifier) (Bioethics Committee at Institute of Mother and Child, Warsaw, Poland)
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-10
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
gestational diabetes mellitus
neonatal hypoglycemia
insulin-treated gestational diabetes
neurodevelopmental outcomes
neonatal hypoglycemia
insulin-treated gestational diabetes
neurodevelopmental outcomes
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalContinuous glucose monitoring 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. | Dexcom ONE Continuous Glucose Monitoring System 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). |
Active ComparatorBlood glucose testing based on standard care procedures 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. | Dexcom ONE Continuous Glucose Monitoring System 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). |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | From birth until 72 hours of life |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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 | 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. | 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. | 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 | 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. | At the time of hospital discharge |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
1 Minute
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Maternal age of 18 years or older
- Singleton pregnancy
- Insulin-treated gestational diabetes mellitus
- 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
Institute of Mother and Child, Warsaw, PolandStudy Responsible Party
Dr. Aleksandra Symonides-Pomianek, Principal Investigator, Resident Physician in Neonatology, Institute of Mother and Child, Warsaw, Poland
No contact data.
1 Study Locations in 1 Countries
Institute of Mother and Child, Warsaw, 01-211, Poland
Aleksandra H Symonides-Pomianek, Contact, +48 22 32 77 406, [email protected]
Paweł Krajewski, MD, PhD, Assoc. Prof., Contact, +48 22 32 77 406, [email protected]
Aleksandra H Symonides-Pomianek, MD, Principal Investigator
Agata Majewska, MD, PhD, Sub-Investigator
Maciej Rączka, MD, Sub-Investigator
Paweł Krajewski, MD, PhD, Assoc. Prof., Sub-Investigator