Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-27 @ 3:11 AM
Study NCT ID:
NCT03804658
Status:
UNKNOWN
Last Update Posted:
2020-10-20
First Post:
2019-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, Plasma and urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-18', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-11', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose variability', 'timeFrame': '3 months', 'description': 'Data from continue glucose monitor system'}], 'secondaryOutcomes': [{'measure': 'brain-derived neurotrophic factor', 'timeFrame': '3 months', 'description': 'Biomarker of cognition'}, {'measure': 'Orexin', 'timeFrame': '3 months', 'description': 'Biomarker of cognition'}, {'measure': 'Renalase', 'timeFrame': '3 months', 'description': 'Biomarker of cognition'}, {'measure': 'Vascular endothelial cell adhesion molecule 1', 'timeFrame': '3 months', 'description': 'Biomarker for inflammation'}, {'measure': 'Health Literacy', 'timeFrame': '3 months', 'description': 'Questionnaire of health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain-derived neurotrophic factor', 'Vascular cell adhesion molecule 1', 'Renalase', 'Orexin', 'Continue glucose monitor'], 'conditions': ['Glucose Variability', 'Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'To assess the effect of glucose monitors on glucose control and cardiovascular risks.', 'detailedDescription': 'The investigators will enroll patients with diabetes. The answered questionnaire and blood samples will be collected at baseline. After change the methods or frequency of glucose monitor, the blood samples will be collected again. The investigators will analyze the factors which may affect the glucose control after changes in methods of glucose monitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with diabetes both in outpatient and inpatient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with diabetes\n\nExclusion Criteria:\n\n* Incooperative patients'}, 'identificationModule': {'nctId': 'NCT03804658', 'briefTitle': 'The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'The Effects of Glucose Monitor on Patients With Diabetes', 'orgStudyIdInfo': {'id': 'CG18308A'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Continue glucose monitor system', 'type': 'DEVICE', 'description': 'The cardiovascular risks and data from continue glucose monitor system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '407', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'I-Te Lee, MD', 'role': 'CONTACT', 'email': 'itlee@vghtc.gov.tw', 'phone': '886-4-23741340'}, {'name': 'I-Te Lee, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Endocrinology and Metabolism in Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'I-Te Lee, MD,PhD', 'role': 'CONTACT', 'email': 'itlee@vghtc.gov.tw', 'phone': '+886-4-23592525', 'phoneExt': '4006'}], 'overallOfficials': [{'name': 'I-Te Lee, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taichung Veterans General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not to share individual participant data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}