Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-03 @ 10:56 PM
Study NCT ID:
NCT03629704
Status:
UNKNOWN
Last Update Posted:
2018-08-14
First Post:
2018-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000095583', 'term': 'Continuous Glucose Monitoring'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003940', 'term': 'Diagnostic Techniques, Endocrine'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-12', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-08-12', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28 day prognosis', 'timeFrame': '0-28 days', 'description': 'Case-fatality at 28 days'}], 'secondaryOutcomes': [{'measure': 'Acute Physiology and Chronic Health Evaluation II score', 'timeFrame': '0-28 days', 'description': 'Acute Physiology and Chronic Health Evaluation II score'}, {'measure': 'Global registry of acute coronary events risk score', 'timeFrame': '0-28 days', 'description': 'Global registry of acute coronary events risk score'}, {'measure': 'Twenty-four-hour mean blood glucose', 'timeFrame': '1-4 days', 'description': 'Twenty-four-hour mean blood glucose assessed by CGM'}, {'measure': 'Mean amplitude of glycemic excursion every 24 h', 'timeFrame': '1-4 days', 'description': 'Mean amplitude of glycemic excursion every 24 h assessed by CGM'}, {'measure': 'Incidence of hypoglycemia', 'timeFrame': '1-4 days', 'description': 'Incidence of hypoglycemia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the glycemic variation using Continuous Glucose Monitoring System in patients in the intensive care unit, find out the occult hypoglycemia, and investigate the relationship between glycemic variation, especially the incidence of hypoglycemia and prognosis of patients. Meanwhile, the inflammatory factors were measured and the relationship between inflammatory factors and glycemic variation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted into care unit of Nanjing First Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with history of diabetes;\n2. Patients without history of diabetes, but their random blood glucoseā§7.8mmol/L or fast blood glucoseā§5 mmol/L;\n3. The patients hospitalized in care unit (ICU or CCU) for more than 48 hours.\n\nExclusion Criteria:\n\n1. Patient had history of mental illness;\n2. Patient was not suitable for using the CGMS;\n3. blood glucose \\> 22.2 mmol/L at admission.'}, 'identificationModule': {'nctId': 'NCT03629704', 'briefTitle': 'Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Relationship Between Blood Glucose Variability and Prognosis in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'KY20170904-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continuous Glucose Monitoring System', 'type': 'DIAGNOSTIC_TEST', 'description': 'Continuous Glucose Monitoring System for 72 hours'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Huiqin Li, MD', 'role': 'CONTACT', 'email': 'lihuiqin496@126.com', 'phone': '+8625-5288-7090'}], 'overallOfficials': [{'name': 'Jianhua Ma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}