Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-04-16 @ 1:57 PM
Study NCT ID:
NCT01714232
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2012-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Blood Glucose Meter Systems
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': '574-257-3063', 'title': 'Jane Wallace', 'organization': 'Ascensia Diabetes Care'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Study Staff Test BGMSs', 'description': 'All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.', 'otherNumAtRisk': 106, 'otherNumAffected': 3, 'seriousNumAtRisk': 106, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoglycemia', 'notes': 'Adverse events were mild, anticipated, non-device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Staff Test BGMSs', 'description': 'All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.'}], 'classes': [{'title': 'Contour® PLUS BGMS', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Accu-Chek® Performa BGMS', 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Accu-Chek® Active BGMS', 'categories': [{'measurements': [{'value': '5.8', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'OneTouch® SelectSimple™ BGMS', 'categories': [{'measurements': [{'value': '10.7', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Freestyle Freedom® BGMS', 'categories': [{'measurements': [{'value': '15.3', 'spread': '0.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all \\|(BG meter)-(BG reference)\\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.', 'unitOfMeasure': 'Percent Difference', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed."}, {'type': 'SECONDARY', 'title': 'MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}, {'units': 'BG Test Results', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Staff Test BGMSs', 'description': 'All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.'}], 'classes': [{'title': 'Contour® PLUS BGMS', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Accu-Chek® Performa BGMS', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Accu-Chek® Active BGMS', 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'OneTouch® SelectSimple™ BGMS', 'categories': [{'measurements': [{'value': '13.3', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Freestyle Freedom® BGMS', 'categories': [{'measurements': [{'value': '17.7', 'spread': '0.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Using fresh and glycolyzed samples with Blood Glucose (BG) \\<=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all \\|(BG meter)-(BG reference)\\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.', 'unitOfMeasure': 'Percent Difference', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BG Test Results', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL.'}, {'type': 'SECONDARY', 'title': 'MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}, {'units': 'BG Test Results', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Staff Test BGMSs', 'description': 'All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.'}], 'classes': [{'title': 'Contour® PLUS BGMS', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Accu-Chek® Performa BGMS', 'categories': [{'measurements': [{'value': '5.9', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Accu-Chek® Active BGMS', 'categories': [{'measurements': [{'value': '5.7', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'OneTouch® SelectSimple™ BGMS', 'categories': [{'measurements': [{'value': '9.8', 'spread': '0.50', 'groupId': 'OG000'}]}]}, {'title': 'Freestyle Freedom® BGMS', 'categories': [{'measurements': [{'value': '14.1', 'spread': '0.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours', 'description': 'Using samples with Blood Glucose \\>180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all \\|(BG meter)-(BG reference)\\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.', 'unitOfMeasure': 'Percent Difference', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BG Test Results', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Staff Test BGMSs', 'description': 'All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Staff Test BGMSs', 'description': 'All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '84'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2012-10-23', 'resultsFirstSubmitDate': '2013-11-08', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-08', 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range', 'timeFrame': '8 hours', 'description': 'Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all \\|(BG meter)-(BG reference)\\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.'}], 'secondaryOutcomes': [{'measure': 'MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)', 'timeFrame': '8 hours', 'description': 'Using fresh and glycolyzed samples with Blood Glucose (BG) \\<=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all \\|(BG meter)-(BG reference)\\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.'}, {'measure': 'MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)', 'timeFrame': '8 hours', 'description': 'Using samples with Blood Glucose \\>180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was calculated from the sum of all \\|(BG meter)-(BG reference)\\|/(BG reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '31789119', 'type': 'DERIVED', 'citation': 'Pardo S, Dunne N, Simmons DA. A comparison of bolus insulin dose errors based on results of a clinical trial of five blood glucose monitoring systems. Ther Deliv. 2019 Dec;10(12):793-799. doi: 10.4155/tde-2019-0047. Epub 2019 Dec 2.'}, {'pmid': '26169192', 'type': 'DERIVED', 'citation': 'Dunne N, Viggiani MT, Pardo S, Robinson C, Parkes JL. Accuracy Evaluation of CONTOUR((R))PLUS Compared With Four Blood Glucose Monitoring Systems. Diabetes Ther. 2015 Sep;6(3):377-88. doi: 10.1007/s13300-015-0121-3. Epub 2015 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).', 'detailedDescription': 'The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems were evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some samples were tested from subject fingertips. Additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18 years of age or older\n* Willing to complete all study procedures\n\nExclusion Criteria:\n\n* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis\n* Hemophilia or any other bleeding disorder\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01714232', 'briefTitle': 'Evaluation of Blood Glucose Meter Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascensia Diabetes Care'}, 'officialTitle': 'Evaluation of Blood Glucose Meter Systems - Contour® PLUS Study', 'orgStudyIdInfo': {'id': 'CTD-2012-008-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Staff Test BGMSs', 'description': 'All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.', 'interventionNames': ['Device: Contour® PLUS BGMS', 'Device: OneTouch® SelectSimple™ BGMS', 'Device: Accu-Chek® Performa BGMS', 'Device: Accu-Chek® Active BGMS', 'Device: Freestyle Freedom® BGMS']}], 'interventions': [{'name': 'Contour® PLUS BGMS', 'type': 'DEVICE', 'description': 'Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).', 'armGroupLabels': ['Study Staff Test BGMSs']}, {'name': 'OneTouch® SelectSimple™ BGMS', 'type': 'DEVICE', 'description': 'Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).', 'armGroupLabels': ['Study Staff Test BGMSs']}, {'name': 'Accu-Chek® Performa BGMS', 'type': 'DEVICE', 'description': 'Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).', 'armGroupLabels': ['Study Staff Test BGMSs']}, {'name': 'Accu-Chek® Active BGMS', 'type': 'DEVICE', 'description': 'Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).', 'armGroupLabels': ['Study Staff Test BGMSs']}, {'name': 'Freestyle Freedom® BGMS', 'type': 'DEVICE', 'description': 'Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).', 'armGroupLabels': ['Study Staff Test BGMSs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46544', 'city': 'Mishawaka', 'state': 'Indiana', 'country': 'United States', 'facility': 'Bayer HealthCare LLC, Diabetes Care', 'geoPoint': {'lat': 41.66199, 'lon': -86.15862}}], 'overallOfficials': [{'name': 'David Simmons, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ascensia Diabetes Care'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}