Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-19 @ 11:39 AM
Study NCT ID:
NCT02390167
Status:
COMPLETED
Last Update Posted:
2019-07-17
First Post:
2015-03-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Ascensia ONYX NEXT 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': {'eventGroups': [{'id': 'EG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.', 'otherNumAtRisk': 375, 'otherNumAffected': 8, 'seriousNumAtRisk': 375, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypoglycemia', 'notes': 'Subjects with hypoglycemia (defined by site as BG level \\< 70 mg/dL) had diabetes and hypoglycemia was resolved at the visit.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 375, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) 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 percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 15% (\\>=100 mg/dL YSI capillary plasma).', 'unitOfMeasure': 'Percent of Results within 15mg/dL/15%', 'reportingStatus': 'POSTED', 'populationDescription': '329 (332 with diabetes-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.'}, {'type': 'SECONDARY', 'title': 'Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '318', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary palm blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm 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 percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 15% (\\>=100 mg/dL YSI capillary plasma).', 'unitOfMeasure': 'Percent of Results within 15mg/dL/15%', 'reportingStatus': 'POSTED', 'populationDescription': '318 (332 with diabetes -14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.'}, {'type': 'SECONDARY', 'title': 'Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Study staff tested subject (332 WITH diabetes) 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 percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 15% (\\>=100 mg/dL YSI capillary plasma).', 'unitOfMeasure': 'Percent of Results within 15mg/dL/15%', 'reportingStatus': 'POSTED', 'populationDescription': '332 Blood glucose results from subjects with diabetes were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI venous plasma) and +/- 15% (\\>=100 mg/dL YSI venous plasma).', 'unitOfMeasure': 'Percent of Results within 15mg/dL/15%', 'reportingStatus': 'POSTED', 'populationDescription': '330 (332-2) Blood glucose results were analyzed. Two (2) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them.'}, {'type': 'SECONDARY', 'title': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) 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 percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.', 'unitOfMeasure': 'Percent of Results within 15%', 'reportingStatus': 'POSTED', 'populationDescription': '372 (375-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.'}, {'type': 'SECONDARY', 'title': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) 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 percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.', 'unitOfMeasure': 'Percent of Results within 20%', 'reportingStatus': 'POSTED', 'populationDescription': '372 (375-3) Blood glucose results were analyzed. Three subjects did not contain meter BG results after three attempts.'}, {'type': 'SECONDARY', 'title': 'Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm 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 percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.', 'unitOfMeasure': 'Percent of Results within 15%', 'reportingStatus': 'POSTED', 'populationDescription': '361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.'}, {'type': 'SECONDARY', 'title': 'Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '361', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm 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 percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.', 'unitOfMeasure': 'Percent of Results within 20%', 'reportingStatus': 'POSTED', 'populationDescription': '361 (375-14) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol. Five (5) subjects had low blood sugar; their palm results were not evaluable per protocol.'}, {'type': 'SECONDARY', 'title': 'Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Study staff tested subject (332 WITH and 43 WITHOUT diabetes) 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 percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.', 'unitOfMeasure': 'Percent of Results within 15%', 'reportingStatus': 'POSTED', 'populationDescription': '375 Blood glucose results were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Study staff tested subject (332 WITH and 43 WITHOUT diabetes) 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 percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.', 'unitOfMeasure': 'Percent of Results within 20%', 'reportingStatus': 'POSTED', 'populationDescription': '375 Blood glucose results were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) 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 percent of BGMS results within +/- 12.5 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 12.5% (\\>=100 mg/dL YSI capillary plasma).', 'unitOfMeasure': 'Percent of Results within12.5mg/dL/12.5%', 'reportingStatus': 'POSTED', 'populationDescription': '329 (332-3) Blood glucose results were analyzed. Three subjects did not obtain meter BG result after three attempts.'}, {'type': 'SECONDARY', 'title': "Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'title': 'I find it easy to do a blood test with this meter.', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}]}]}, {'title': 'The meter display was easy to see and read.', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000'}]}]}, {'title': 'It was easy to understand my test results.', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}]}]}, {'title': 'I like the overall meter design.', 'categories': [{'measurements': [{'value': '97.3', 'groupId': 'OG000'}]}]}, {'title': 'I find the meter easy to use.', 'categories': [{'measurements': [{'value': '97.9', 'groupId': 'OG000'}]}]}, {'title': 'Instructions (User Guide) were easy to understand.', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000'}]}]}, {'title': 'Instructions clearly explain how to run a test.', 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000'}]}]}, {'title': 'Instructions clearly explain meter error messages.', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': "Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.", 'unitOfMeasure': 'Percent of Subjects who responded', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS", 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'title': 'I find it easy to do a blood test with this meter.', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}, {'title': 'The meter display was easy to see and read.', 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000'}]}]}, {'title': 'It was easy to understand my test results.', 'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}]}]}, {'title': 'I like the overall meter design.', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000'}]}]}, {'title': 'I find the meter easy to use.', 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}, {'title': 'Instructions (User Guide) were easy to understand.', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000'}]}]}, {'title': 'Instructions clearly explain how to run a test.', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}]}]}, {'title': 'Instructions clearly explain meter error messages.', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': "Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'.", 'unitOfMeasure': 'Percent of Subjects who responded', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose", 'denoms': [{'units': 'Participants', 'counts': [{'value': '332', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'title': 'Acc:important to help me talk w my HCP.', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Acc:important to help w self-monitor satisfaction.', 'categories': [{'measurements': [{'value': '99.70', 'groupId': 'OG000'}]}]}, {'title': 'Acc:important to help w managing my diabetes.', 'categories': [{'measurements': [{'value': '99.40', 'groupId': 'OG000'}]}]}, {'title': 'Acc:important to help prevent low blood sugar', 'categories': [{'measurements': [{'value': '99.69', 'groupId': 'OG000'}]}]}, {'title': 'Acc:important to understand food/exercise effects.', 'categories': [{'measurements': [{'value': '99.70', 'groupId': 'OG000'}]}]}, {'title': 'Acc:help w using results to better control diabete', 'categories': [{'measurements': [{'value': '99.40', 'groupId': 'OG000'}]}]}, {'title': 'Acc:important to achieve greater peace of mind.', 'categories': [{'measurements': [{'value': '99.09', 'groupId': 'OG000'}]}]}, {'title': 'I prefer the meter I just used to my regular meter', 'categories': [{'measurements': [{'value': '92.09', 'groupId': 'OG000'}]}]}, {'title': 'I use my meter - my care provider gave it to me.', 'categories': [{'measurements': [{'value': '85.27', 'groupId': 'OG000'}]}]}, {'title': 'I use my current meter -my insurance covers strips', 'categories': [{'measurements': [{'value': '85.62', 'groupId': 'OG000'}]}]}, {'title': 'I use my current meter-I think it is most accurate', 'categories': [{'measurements': [{'value': '84.09', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': "Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'.", 'unitOfMeasure': 'Percent of Subjects who responded', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '99.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subject WITH and WITHOUT 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 percent of BGMS results within +/- 15 mg/dL (\\< 75 mg/dL YSI capillary plasma) and +/- 15% (\\>= 75 mg/dL YSI capillary plasma).', 'unitOfMeasure': 'Percent of Results within 15mg/dL/15%', 'reportingStatus': 'POSTED', 'populationDescription': '372 (375 - 3) Blood glucose results were analyzed. Three subjects did not obtain meter BG results after three attempts.'}, {'type': 'SECONDARY', 'title': 'Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).'}], 'classes': [{'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour', 'description': 'Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm 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 percent of BGMS results within +/- 15 mg/dL (\\< 75 mg/dL YSI capillary plasma) and +/- 15% (\\>= 75 mg/dL YSI capillary plasma).', 'unitOfMeasure': 'Percent of Results within 15mg/dL/15%', 'reportingStatus': 'POSTED', 'populationDescription': '366 (375-9) Blood glucose results were analyzed. Nine (9) subjects with low blood sugar did not attempt palm testing per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}]}, {'type': 'With Diabetes', 'achievements': [{'groupId': 'FG000', 'numSubjects': '333'}]}, {'type': 'Without Diabetes', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Persons With and Without Diabetes', 'description': 'Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).\n\nThe ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '202', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '174', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '321', 'groupId': 'BG000'}]}]}, {'title': 'Ethnicity Unknown or Not Reported', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '292', 'groupId': 'BG000'}]}]}, {'title': 'Race Unknown or Not Reported', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Number of responses'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '376', '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': 376}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-02', 'studyFirstSubmitDate': '2015-03-11', 'resultsFirstSubmitDate': '2016-12-30', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-09', 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) 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 percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 15% (\\>=100 mg/dL YSI capillary plasma).'}], 'secondaryOutcomes': [{'measure': 'Percent of Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) self-tested Alternate Site (AST) palm 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 percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 15% (\\>=100 mg/dL YSI capillary plasma).'}, {'measure': 'Percent of Subject Fingerstick Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff', 'timeFrame': '1 hour', 'description': 'Study staff tested subject (332 WITH diabetes) 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 percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 15% (\\>=100 mg/dL YSI capillary plasma).'}, {'measure': 'Percent of Venous Blood Glucose (BG) Results (From Subjects WITH Diabetes) Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Tested by Study Staff', 'timeFrame': '1 hour', 'description': 'Study staff tested venous blood of 332 subjects WITH diabetes using an Investigational Blood Glucose Monitoring System (BGMS). Venous BGMS results were compared with subject venous plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer venous plasma BG results were used to calculate the percent of BGMS results within +/- 15 mg/dL (\\<100 mg/dL YSI venous plasma) and +/- 15% (\\>=100 mg/dL YSI venous plasma).'}, {'measure': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) and WITHOUT Diabetes (43) 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 percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.'}, {'measure': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) 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 percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.'}, {'measure': 'Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm 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 percent of BGMS results within +/- 15% of the laboratory reference method across the entire tested YSI glucose range.'}, {'measure': 'Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH diabetes (332) and WITHOUT diabetes (43) self-tested AST palm 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 percent of BGMS results within +/- 20% of the laboratory reference method across the entire tested YSI glucose range.'}, {'measure': 'Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Tested By Study Staff', 'timeFrame': '1 hour', 'description': 'Study staff tested subject (332 WITH and 43 WITHOUT diabetes) 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 percent of BGMS results within +/- 15% of the laboratory method across the entire tested YSI glucose range.'}, {'measure': 'Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Tested By Study Staff', 'timeFrame': '1 hour', 'description': 'Study staff tested subject (332 WITH and 43 WITHOUT diabetes) 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 percent of BGMS results within +/- 20% of the laboratory method across the entire tested YSI glucose range.'}, {'measure': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100 mg/dL) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subjects WITH Diabetes (332) 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 percent of BGMS results within +/- 12.5 mg/dL (\\<100 mg/dL YSI capillary plasma) and +/- 12.5% (\\>=100 mg/dL YSI capillary plasma).'}, {'measure': "Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS", 'timeFrame': '1 hour', 'description': "Staff obtained responses from persons WITH Diabetes (332) using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'."}, {'measure': "Percent of Responses From Persons WITH and WITHOUT Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS", 'timeFrame': '1 hour', 'description': "Staff obtained responses from persons WITH and WITHOUT Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'."}, {'measure': "Percent of Responses From Persons WITH Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding Views/Behaviors Related to Self-Monitoring Blood Glucose", 'timeFrame': '1 hour', 'description': "Staff obtained responses from persons WITH Diabetes using short questionnaires to provide feedback on views and behaviors related to managing their diabetes. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'Choose Not to Answer'."}, {'measure': 'Percent of Self-Test Fingerstick Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subject WITH and WITHOUT 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 percent of BGMS results within +/- 15 mg/dL (\\< 75 mg/dL YSI capillary plasma) and +/- 15% (\\>= 75 mg/dL YSI capillary plasma).'}, {'measure': 'Percent of Self-Test Alternate Site Palm Blood Glucose (BG) Results (From Subjects WITH and WITHOUT Diabetes) Within +/- 15 mg/dL (<75 mg/dL) and Within +/- 15% (>= 75 mg/dL) of Laboratory Glucose Method', 'timeFrame': '1 hour', 'description': 'Untrained subject WITH and WITHOUT diabetes self-tested Alternate Site (AST) palm 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 percent of BGMS results within +/- 15 mg/dL (\\< 75 mg/dL YSI capillary plasma) and +/- 15% (\\>= 75 mg/dL YSI capillary plasma).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if untrained subjects with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, 18 years of age and older\n* Able to speak, read, and understand English\n* Willing to complete all study procedures\n\nExclusion Criteria:\n\n* Hemophilia or any other bleeding disorder\n* Pregnancy\n* Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM\n* Previously participated in a blood glucose monitoring study using the ONYX NEXT or ONYX PLUS BGMS\n* Working for a medical laboratory, hospital, or other clinical setting that involves training on or clinical use of blood glucose monitors\n* Working for a competitive medical device company, or having an immediate family member who works for such a company\n* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk\n\nGeneral enrollment guidelines:\n\n* At least 70% of subjects will be younger than age 65\n* At least 10% (approximately 10-15%) of subjects will be naive users\n* At least 20% of subjects with diabetes will have type 1 diabetes'}, 'identificationModule': {'nctId': 'NCT02390167', 'briefTitle': 'Evaluation of a Ascensia ONYX NEXT Investigational Blood Glucose Monitoring System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascensia Diabetes Care'}, 'officialTitle': 'User Performance of the ONYX NEXT Blood Glucose Monitoring System', 'orgStudyIdInfo': {'id': 'GCA-PRO-2014-004-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Persons With Diabetes', 'description': 'Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).', 'interventionNames': ['Device: ONYX NEXT BGMS']}], 'interventions': [{'name': 'ONYX NEXT BGMS', 'type': 'DEVICE', 'description': "Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' venous plasma.", 'armGroupLabels': ['Persons With Diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92026', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'AMCR Institute', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'overallOfficials': [{'name': 'Timothy Bailey, MD, FACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMCR Institute'}, {'name': 'Mark Christiansen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diablo Clinical Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascensia Diabetes Care', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}