Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-30 @ 3:08 PM
Study NCT ID:
NCT05449795
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2022-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jane.wallace@ascensia.com', 'phone': '5748501467', 'title': 'Jane Wallace', 'organization': 'Ascensia Diabetes Care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Arterial Blood Results', 'description': 'Samples collected and tested in duplicate by BGMS and compared to laboratory results', 'otherNumAtRisk': 120, 'deathsNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'blood samples', 'counts': [{'value': '240', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arterial Blood Results', 'description': 'Samples collected and tested in duplicate by BGMS and compared to laboratory results'}], 'classes': [{'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 day', 'description': 'At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \\<100 mg/dL(5.55 mmol/L).', 'unitOfMeasure': 'blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'blood samples', 'denomUnitsSelected': 'blood samples', 'populationDescription': 'arterial samples'}, {'type': 'PRIMARY', 'title': 'Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'blood samples', 'counts': [{'value': '240', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arterial Blood Results', 'description': 'Samples collected and tested in duplicate by BGMS and compared to laboratory results'}], 'classes': [{'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 day', 'description': 'At least 98% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \\< 75 mg/dL(4.16 mmol/L).', 'unitOfMeasure': 'blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'blood samples', 'denomUnitsSelected': 'blood samples', 'populationDescription': 'Arterial samples tested.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arterial Blood Results', 'description': 'Samples collected and tested in duplicate by BGMS and compared to laboratory results'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '240', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '240', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'blood samples'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}, {'units': 'blood samples', 'counts': [{'value': '240', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arterial Blood Results', 'description': 'Samples collected and tested in duplicate by BGMS and compared to laboratory results'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}, {'units': 'blood samples', 'counts': [{'value': '240', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '59.2', 'spread': '16.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}, {'units': 'blood samples', 'counts': [{'value': '240', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'blood samples', 'counts': [{'value': '240', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}, {'units': 'blood samples', 'counts': [{'value': '240', 'groupId': 'BG000'}]}], 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'blood samples', 'populationDescription': '120 participants were enrolled in the study. Each participant provided two blood samples that were tested. So the number of results analyzed is 240.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-09', 'size': 3960775, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-09T14:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2022-07-05', 'resultsFirstSubmitDate': '2024-10-09', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-16', 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Results From the Contour Next BGMSs Reference Values Within ±12.5% of Reference Values', 'timeFrame': '1 day', 'description': 'At least 95% of all blood glucose results shall fall within ±12.5% of reference values (laboratory method) for glucose concentration ≥100 mg/dL(5.55 mmol/L )and within ±12 mg/dL(±0.67 mmol/L) at glucose concentrations \\<100 mg/dL(5.55 mmol/L).'}, {'measure': 'Number of Results From the Contour Plus Elite BGMSs Reference Values Within ±12.5% of Reference Values', 'timeFrame': '1 day', 'description': 'At least 98% of values should be within ±12.5% of reference values (laboratory method) for glucose concentration ≥75 mg/dL(4.16 mmol/L) and within ±15 mg/dL(±0.83 mmol/L) at glucose concentrations \\< 75 mg/dL(4.16 mmol/L).'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.', 'detailedDescription': 'This trial will evaluate the performance of both Contour Next BGMS and Contour Plus Elite BGMS using arterial blood from adult patients hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)). The investigational BGMS will be tested by a Point-of-Care (POC) operator in a clinical setting using residual arterial blood samples from adults who underwent prescribed arterial blood tests that were deemed necessary due to their medical conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- The subject population will consist of adults who are hospitalized in a Critical Care Unit, (medical and surgical intensive care units (ICUs)) at the Investigational site.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are at least 18 years old.\n* Residual Arterial blood samples collected from subjects hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)).\n* Sample blood volume must be sufficient to complete investigational testing procedures clinical laboratory testing.\n\nExclusion Criteria:\n\n\\- Residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.'}, 'identificationModule': {'nctId': 'NCT05449795', 'briefTitle': 'Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascensia Diabetes Care'}, 'officialTitle': 'Evaluation of the Performance of Contour Next® and Contour Plus Elite® Blood Glucose Monitoring Systems (BGMS) in Arterial Blood Samples From Hospitalized Adults', 'orgStudyIdInfo': {'id': 'GCA-PRO-2021-004-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Device: Contour Next and Contour Plus Elite BGMS testing of arterial blood', 'type': 'DEVICE', 'description': 'The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital , ICU Research Unit', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}