Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01268267
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2010-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting
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': 'carmine.greene@ascensia.com', 'phone': '574-257-3040', 'title': 'Carmine Greene', 'organization': 'Ascensia Diabetes Care'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Each subject participated for approximately 2 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.', 'otherNumAtRisk': 94, 'otherNumAffected': 7, 'seriousNumAtRisk': 94, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 94, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}, {'units': 'Blood glucose test results', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.'}], 'classes': [{'title': '# within +/-15mg/dL(<75mg/dL) or 20% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000'}]}]}, {'title': '# within +/-15mg/dL(<75mg/dL) or 15% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}]}]}, {'title': '# within +/-10mg/dL(<75mg/dL) or 10% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}]}]}, {'title': '# within +/-5mg/dL(<75mg/dL) or 5% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results \\<75mg/dL) or +/- 5 to 20% (for reference BG results \\>=75mg/dL) of the reference method results.', 'unitOfMeasure': 'Number of BG test results', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Blood glucose test results', 'denomUnitsSelected': 'Participants', 'populationDescription': "One subject was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available."}, {'type': 'SECONDARY', 'title': 'Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'BG test results', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.'}], 'classes': [{'title': '# within +/-15mg/dL(<75mg/dL) or 20% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}]}]}, {'title': '# within +/-15mg/dL(<75mg/dL) or 15% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}, {'title': '# within +/-10mg/dL(<75mg/dL) or 10% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}, {'title': '# within +/-5mg/dL(<75mg/dL) or 5% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results \\<75mg/dL) or +/- 5% to 20% (for reference BG results \\>=75mg/dL) of the reference method results.', 'unitOfMeasure': 'Number of BG test results', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BG test results', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.'}], 'classes': [{'title': 'Turn meter on/off', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Date and time set on meter', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Normal control testing', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Subject blood testing - fingerstick', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Subject blood testing - palm (of 90)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Subject blood testing - forearm (of 90)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Understand underfill / ability to apply more blood', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 participants were rated for those particular tasks.'}, {'type': 'SECONDARY', 'title': 'Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'BG test results', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.'}], 'classes': [{'title': '# within +/-15mg/dL(<75mg/dL) or 20% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}]}]}, {'title': '# within +/-15mg/dL(<75mg/dL) or 15% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}, {'title': '# within +/-10mg/dL(<75mg/dL) or 10% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': '# within +/-5mg/dL(<75mg/dL) or 5% (>=75mg/dL)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours', 'description': 'Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results \\<75mg/dL) or +/- 5% to 20% (for reference BG results \\>=75mg/dL) of the reference method results.', 'unitOfMeasure': 'Number of BG test results', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'BG test results', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes use an investigational blood glucose monitoring system.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '93', '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': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-29', 'studyFirstSubmitDate': '2010-12-28', 'resultsFirstSubmitDate': '2012-04-27', 'studyFirstSubmitQcDate': '2010-12-28', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-27', 'studyFirstPostDateStruct': {'date': '2010-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method', 'timeFrame': '2 hours', 'description': 'Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results \\<75mg/dL) or +/- 5 to 20% (for reference BG results \\>=75mg/dL) of the reference method results.'}], 'secondaryOutcomes': [{'measure': 'Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method', 'timeFrame': '2 hours', 'description': 'Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results \\<75mg/dL) or +/- 5% to 20% (for reference BG results \\>=75mg/dL) of the reference method results.'}, {'measure': 'Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)', 'timeFrame': '2 hours', 'description': 'Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects (1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.'}, {'measure': 'Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method', 'timeFrame': '2 hours', 'description': 'Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 20 mg/dL (for reference BG results \\<75mg/dL) or +/- 5% to 20% (for reference BG results \\>=75mg/dL) of the reference method results.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance and acceptability of an investigational blood glucose monitoring system, which includes meter and sensor strip.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18 years of age and above\n* Type 1 or type 2 diabetes\n* Currently self-testing blood glucose at home at least twice daily\n* Able to speak, read, and understand English\n* Willing to complete all study procedures\n\nExclusion Criteria:\n\n* Currently Pregnant\n* Hemophilia or any other bleeding disorder\n* Employee of competitive medical device company\n* Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study'}, 'identificationModule': {'nctId': 'NCT01268267', 'briefTitle': 'Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascensia Diabetes Care'}, 'officialTitle': 'Clinical Trial Protocol for Ninja 2 System With TATSU Sensor', 'orgStudyIdInfo': {'id': 'CTD-2010-008-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intended Users of the System', 'description': 'Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using an investigational blood glucose monitoring system (development name Ninja 2).', 'interventionNames': ['Device: Ninja 2 Investigational Blood Glucose Monitoring System']}], 'interventions': [{'name': 'Ninja 2 Investigational Blood Glucose Monitoring System', 'type': 'DEVICE', 'description': "Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter and an investigational sensor. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.", 'armGroupLabels': ['Intended Users of the System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}], 'overallOfficials': [{'name': 'Timothy Bailey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMCR Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}