Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:33 AM
Study NCT ID:
NCT07462793
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'In the control group, CGM data are not visible to the clinical team and do not influence clinical management.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal hypoglycaemia', 'timeFrame': 'From birth until 72 hours of life', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Total cumulative duration of hypoglycaemia per neonate within the first 72 hours of life', 'timeFrame': 'From birth until 72 hours of life', 'description': '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.'}, {'measure': 'Number of hypoglycaemia-related clinical interventions per neonate during the monitoring period', 'timeFrame': 'From birth until 72 hours of life', 'description': 'Number of clinical interventions (feeding, oral glucose, intravenous glucose administration) per neonate during the monitoring period due to hypoglycaemia'}, {'measure': 'Number of capillary blood glucose measurements per neonate', 'timeFrame': 'From birth until 72 hours of life', 'description': 'Number of capillary blood glucose measurements per neonate during the monitoring period in the control group.'}, {'measure': 'Measures of glucose variability per neonate within the first 72 hours of life', 'timeFrame': 'First 72 hours after birth', 'description': 'Glucose variability metrics derived from CGM data, including:\n\n* standard deviation (SD) of glucose concentration, and\n* coefficient of variation (CV), calculated as SD divided by mean glucose and expressed as a percentage.'}, {'measure': 'Percentage of time with glucose <40 mg/dL', 'timeFrame': 'From birth until 72 hours of life', 'description': 'Percentage of time with glucose \\<40 mg/dL (2.2 mmol/L) per neonate within the first 72 hours after birth'}, {'measure': 'Proportion of neonates by feeding type at hospital discharge', 'timeFrame': 'At the time of hospital discharge', 'description': 'Proportion of neonates receiving exclusive breastfeeding, mixed feeding (breast milk and formula), or exclusive formula feeding at the time of hospital discharge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gestational diabetes mellitus', 'neonatal hypoglycemia', 'insulin-treated gestational diabetes', 'neurodevelopmental outcomes'], 'conditions': ['Neonatal Hypoglycemia', 'Gestational Diabetes Mellitus (GDM)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nNeonatal 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.\n\nFollowing 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.\n\nCurrent 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.\n\nContinuous 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.\n\nThe 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.\n\nIn 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.\n\nIn 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.\n\nIn both groups, CGM will continuously collect glucose data for the first 72 hours after birth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Minutes', 'minimumAge': '1 Minute', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Maternal age of 18 years or older\n* Singleton pregnancy\n* Insulin-treated gestational diabetes mellitus\n\nExclusion Criteria:\n\n* Multifetal pregnancy\n* Congenital malformations or metabolic defects in the newborn\n* Preterm birth (defined as birth \\<37 weeks of gestation)\n* Smoking during pregnancy\n* Preeclampsia, fetal growth restriction\n* Perinatal asphyxia\n* Congenital infections in the newborn\n* Adverse skin reactions (eczema, wounds) in the planned sensor insertion area'}, 'identificationModule': {'nctId': 'NCT07462793', 'acronym': 'COMET-GDM', 'briefTitle': 'COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Mother and Child, Warsaw, Poland'}, 'officialTitle': 'COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '42/2025'}, 'secondaryIdInfos': [{'id': '42/2025', 'type': 'OTHER', 'domain': 'Bioethics Committee at Institute of Mother and Child, Warsaw, Poland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous glucose monitoring', 'description': '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.', 'interventionNames': ['Device: Dexcom ONE Continuous Glucose Monitoring System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blood glucose testing based on standard care procedures', 'description': '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.', 'interventionNames': ['Device: Dexcom ONE Continuous Glucose Monitoring System']}], 'interventions': [{'name': 'Dexcom ONE Continuous Glucose Monitoring System', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Blood glucose testing based on standard care procedures', 'Continuous glucose monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-211', 'city': 'Warsaw', 'country': 'Poland', 'contacts': [{'name': 'Aleksandra H Symonides-Pomianek', 'role': 'CONTACT', 'email': 'aleksandra.symonides@imid.med.pl', 'phone': '+48 22 32 77 406'}, {'name': 'Paweł Krajewski, MD, PhD, Assoc. Prof.', 'role': 'CONTACT', 'email': 'pawel.krajewski@imid.med.pl', 'phone': '+48 22 32 77 406'}, {'name': 'Aleksandra H Symonides-Pomianek, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Agata Majewska, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Maciej Rączka, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paweł Krajewski, MD, PhD, Assoc. Prof.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute of Mother and Child', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Mother and Child, Warsaw, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician in Neonatology', 'investigatorFullName': 'Dr. Aleksandra Symonides-Pomianek', 'investigatorAffiliation': 'Institute of Mother and Child, Warsaw, Poland'}}}}