Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-01 @ 4:59 AM
Study NCT ID:
NCT02718703
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2016-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2016-03-01', 'studyFirstSubmitQcDate': '2016-03-18', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument.', 'timeFrame': 'Up to 1 hour', 'description': 'UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional)'}, {'measure': 'System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument.', 'timeFrame': 'Up to 1 hour', 'description': 'Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.'}, {'measure': 'System Use Evaluation - HCP ( HealthCare Professional) questionnaire', 'timeFrame': 'Up to 1 hour', 'description': 'Assessing use of BGMS and supporting material by subject.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Summary of Inclusion Criteria:\n\n* Able to voluntarily provide written informed consent to participate in the study.\n* User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.\n\nExclusion Criteria:\n\n* Female subjects who are pregnant or lactating.\n* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.\n* User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.'}, 'identificationModule': {'nctId': 'NCT02718703', 'briefTitle': 'Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'LifeScan'}, 'officialTitle': 'Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation', 'orgStudyIdInfo': {'id': '3129822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood Glucose monitoring System (BGMS)', 'description': 'Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)', 'interventionNames': ['Device: Blood Glucose Monitoring System.']}], 'interventions': [{'name': 'Blood Glucose Monitoring System.', 'type': 'DEVICE', 'description': 'In vitro diagnostic medical device', 'armGroupLabels': ['Blood Glucose monitoring System (BGMS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT2 7BA', 'city': 'Belfast', 'state': 'Antrim', 'country': 'United Kingdom', 'facility': 'BioKinetic Europe Ltd', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'Lorna Stewart', 'role': 'STUDY_DIRECTOR', 'affiliation': 'LifeScan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LifeScan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}