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De klinische studie NCT07462793 (COMET-GDM) voor Neonatale hypoglykemie, Zwangerschapsdiabetes mellitus (GDM) is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM) 120
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De klinische studie NCT07462793 (COMET-GDM) is een interventioneel studie bij Neonatale hypoglykemie, Zwangerschapsdiabetes mellitus (GDM) met de status nog niet rekruterend. De inclusie van 120 deelnemers start op 1 maart 2026. De studie wordt geleid door Institute of Mother and Child, Warsaw, Poland en de voltooiing is gepland op 1 december 2027. Laatste update op ClinicalTrials.gov: 10 maart 2026.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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...Toon meer
Officiële titel
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
Aandoeningen
Neonatale hypoglykemieZwangerschapsdiabetes mellitus (GDM)Andere studie-ID's
- COMET-GDM
- 42/2025
- 42/2025 (Overige identificatiecode) (Bioethics Committee at Institute of Mother and Child, Warsaw, Poland)
NCT-ID
Startdatum (Werkelijk)
2026-03
Laatste update geplaatst
2026-03-10
Verwachte einddatum
2027-12
Inschrijving (Geschat)
120
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
gestational diabetes mellitus
neonatal hypoglycemia
insulin-treated gestational diabetes
neurodevelopmental outcomes
neonatal hypoglycemia
insulin-treated gestational diabetes
neurodevelopmental outcomes
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelContinuous 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). |
Actieve 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). |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
1 Minute
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
- 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, PolandVerantwoordelijke instantie
Dr. Aleksandra Symonides-Pomianek, Hoofdonderzoeker, Resident Physician in Neonatology, Institute of Mother and Child, Warsaw, Poland
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen
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, Hoofdonderzoeker
Agata Majewska, MD, PhD, Subonderzoeker
Maciej Rączka, MD, Subonderzoeker
Paweł Krajewski, MD, PhD, Assoc. Prof., Subonderzoeker