Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-29 @ 8:55 AM
Study NCT ID:
NCT01829061
Status:
TERMINATED
Last Update Posted:
2016-03-29
First Post:
2013-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole Blood Venous Draw and Capillary Blood - IVD Study'}, 'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Data for Study Devices vs. Predicate not within allowable ranges.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-28', 'studyFirstSubmitDate': '2013-04-01', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2016-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C', 'timeFrame': '10 Days', 'description': 'The objective is to conduct a method comparison between both the Quo-Test and Quo-Lab investigational devices and the reference method \\[Tosoh G8 (K071132)\\]. The reference method also serves as the predicate for the premarket notifications for both investigational devices. Both capillary and venous samples will be tested on the Quo-Test A1C System and Quo-Lab A1C Test, while only venous samples will be tested on the reference method.'}], 'secondaryOutcomes': [{'measure': 'Obtain CLIA Waiver Status for the Quo-Test', 'timeFrame': '10 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type I Diabetes', 'Type II Diabetes', 'HbA1C'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "From site's patient database", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or over\n* Able to read English\n* Read, understood and signed the Informed Consent Form\n* Agrees to participate and does not withdraw\\\\\n* Either healthy (without diabetes) or has Type 1 or Type 2 diabetes\n\nExlcusion Criteria:\n\n• Declines participation or withdraws before study completion'}, 'identificationModule': {'nctId': 'NCT01829061', 'briefTitle': 'Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quotient Diagnostics Limited'}, 'officialTitle': 'Reproducibility and Method Comparison of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver of the Quo-Test™ A1C System', 'orgStudyIdInfo': {'id': 'QDL Clinical Studies'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '55318', 'city': 'Chaska', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Ridgeview Research', 'geoPoint': {'lat': 44.78941, 'lon': -93.60218}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'overallOfficials': [{'name': 'Tim Bailey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMCR Institute'}, {'name': 'Stephanie Svoboda, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ridgeview Research'}, {'name': 'Michael Gardner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri-Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quotient Diagnostics Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}