Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-02 @ 6:43 PM
Study NCT ID:
NCT01859494
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2013-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of an Investigational Blood Glucose Monitoring System
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, Deputy Director for Global Clinical Affairs', 'organization': 'Ascensia Diabetes Care'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Subject visits were approximately 1 hour.', 'eventGroups': [{'id': 'EG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.', 'otherNumAtRisk': 219, 'otherNumAffected': 8, 'seriousNumAtRisk': 219, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoglycemia', 'notes': "Subjects' hypoglycemia events were resolved at the visit.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 219, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\\<75mg/dL YSI capillary plasma) or +/- 20% (\\>=75mg/dL YSI capillary plasma).', 'unitOfMeasure': 'Blood Glucose results within 15mg/dL/20%', 'reportingStatus': 'POSTED', 'populationDescription': '218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject.'}, {'type': 'SECONDARY', 'title': 'Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\\<100mg/dL YSI capillary plasma) or +/- 15% (\\>=100mg/dL YSI capillary plasma)', 'unitOfMeasure': 'Blood Glucose results within 15mg/dL/15%', 'reportingStatus': 'POSTED', 'populationDescription': '218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.'}, {'type': 'SECONDARY', 'title': 'Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '214', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (\\<100mg/dL YSI capillary plasma) or +/- 12.5% (\\>=100mg/dL YSI capillary plasma)', 'unitOfMeasure': 'Bld Glucose results w/in 12.5mg/dL/12.5%', 'reportingStatus': 'POSTED', 'populationDescription': '218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject.'}, {'type': 'SECONDARY', 'title': 'Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '209', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (\\<75mg/dL YSI capillary plasma) or +/- 20% (\\>=75mg/dL YSI capillary plasma)', 'unitOfMeasure': 'Blood Glucose results within 15mg/dL/20%', 'reportingStatus': 'POSTED', 'populationDescription': '211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing.'}, {'type': 'SECONDARY', 'title': 'Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (\\<75mg/dL YSI capillary plasma) or +/- 20% (\\>=75mg/dL YSI capillary plasma)', 'unitOfMeasure': 'Blood Glucose results within 15mg/dL/20%', 'reportingStatus': 'POSTED', 'populationDescription': '218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject.'}, {'type': 'SECONDARY', 'title': "Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements", 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'classes': [{'title': 'I find it easy to do a blood test with this meter.', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}, {'title': 'The meter display was easy to see and read.', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}, {'title': 'It was easy to understand my test results.', 'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}]}]}, {'title': 'I like the overall meter design.', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}]}]}, {'title': 'I find the meter easy to use.', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}]}]}, {'title': 'The instructions were easy to understand.', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}]}]}, {'title': 'Instructions clearly explain how to run a test.', 'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}, {'title': 'Instructions clearly explain meter error messages.', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': "Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'.", 'unitOfMeasure': 'Participant Responses', 'reportingStatus': 'POSTED', 'populationDescription': '218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '218'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.\n\nNINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '95'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '197', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '194', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects provided more than one choice for Race, therefore the apparent frequency total for Race was different from the number of subjects.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '221', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Two subjects were screen failures due to not meeting enrollment criteria. 221 consented but only 219 enrolled into study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2013-05-19', 'resultsFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2013-05-19', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-09-09', 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\\<75mg/dL YSI capillary plasma) or +/- 20% (\\>=75mg/dL YSI capillary plasma).'}], 'secondaryOutcomes': [{'measure': 'Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (\\<100mg/dL YSI capillary plasma) or +/- 15% (\\>=100mg/dL YSI capillary plasma)'}, {'measure': 'Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (\\<100mg/dL YSI capillary plasma) or +/- 12.5% (\\>=100mg/dL YSI capillary plasma)'}, {'measure': 'Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (\\<75mg/dL YSI capillary plasma) or +/- 20% (\\>=75mg/dL YSI capillary plasma)'}, {'measure': 'Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff', 'timeFrame': '1 hour', 'description': 'Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (\\<75mg/dL YSI capillary plasma) or +/- 20% (\\>=75mg/dL YSI capillary plasma)'}, {'measure': "Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements", 'timeFrame': '1 hour', 'description': "Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females, 18 years of age and older\n2. People with type 1 or type 2 diabetes\n3. Able to speak, read, and understand English\n4. Willing to complete all study procedures\n\nExclusion Criteria:\n\n1. Hemophilia or any other bleeding disorder\n2. Pregnancy\n3. Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM\n4. Previously participated in a BG monitor study using the Ninja 3 BGMS\n5. Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors\n6. Working for a competitive medical device company, or having an immediate family member who works for such a company\n7. A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk.\n\nThe enrollment criteria for the study population:\n\n1. At least 60% of subjects will be younger than age 65\n2. At least 20% of subjects will have type 1 diabetes\n3. At least 50% of subjects with type 2 diabetes wil be insulin users.'}, 'identificationModule': {'nctId': 'NCT01859494', 'briefTitle': 'Evaluation of an Investigational Blood Glucose Monitoring System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascensia Diabetes Care'}, 'officialTitle': 'Performance of the Ninja 3 Blood Glucose Monitoring System', 'orgStudyIdInfo': {'id': 'CTD-2012-009-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Users of the Monitoring System', 'description': 'Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.', 'interventionNames': ['Device: NINJA 3 Investigational Blood Glucose Monitoring System']}], 'interventions': [{'name': 'NINJA 3 Investigational Blood Glucose Monitoring System', 'type': 'DEVICE', 'description': 'Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.', 'armGroupLabels': ['Users of the Monitoring System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}], 'overallOfficials': [{'name': 'Timothy Bailey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMCR Institute'}, {'name': 'Leslie J Klaff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rainier Clinical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'When it is cleared, results data will be provided.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}