| Primary | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Untrained subjects WITH diabetes (329) 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 +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 324 (329-5) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Three subjects did not obtain meter BG result after three attempts. | Posted | | Number | | Blood glucose results within 15mg/dL/15% | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With Diabetes | Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. |
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| Secondary | Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method | Study staff tested venous blood of subjects WITH diabetes (329) 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 number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI venous plasma) and +/-15% (>=100 mg/dL YSI venous plasma). | 318 (329-11) Blood glucose results were analyzed. Eleven (11) subjects had unsuccessful venipuncture attempts, so no venous results were obtained for them. | Posted | | Number | | Blood glucose results within 15mg/dL/15% | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With Diabetes | Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject venous blood from subjects WITH Diabetes (329) and BG results were compared to reference method results obtained from subject venous plasma. |
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| Secondary | Number of Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff | Study staff obtained and tested subject (329 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 capillary plasma results were used to calculate the number of BGMS results within +/-15 mg/dL (<100 mg/dL YSI capillary plasma) and +/-15% (>=100 mg/dL YSI capillary plasma). | 326 (329-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. One subject had no BG result obtained by study staff. One subject's staff-obtained BG result was not evaluable due to protocol deviation. | Posted | | Number | | Blood glucose results within 15mg/dL/15% | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With Diabetes | Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood (329 WITH Diabetes) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. |
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| Secondary | Number of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | Staff obtained responses from persons WITH diabetes (329) 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 'Neutral' or 'Disagree' or 'Strongly Disagree.' | | Posted | | Number | | number who strongly agree,agree,neutral | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With Diabetes | Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes (329) used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma. |
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| Secondary | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method Across the Tested Glucose Range | Untrained subjects WITH diabetes (329) 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 number of BGMS results within +/-15% of the laboratory method across the entire tested YSI glucose range. | 365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts. | Posted | | Number | | Blood glucose results within +/- 15% | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With and Without Diabetes | Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. |
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| Secondary | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method Across the Tested Glucose Range | Untrained subjects WITH diabetes (329) 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 number of BGMS results within +/-20% of the laboratory method across the entire tested YSI glucose range. | 365 (372-7) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject time between subject meter test and collection of subject reference sample exceeded time allowed in protocol. Five subjects did not obtain meter BG result after three attempts. | Posted | | Number | | Blood glucose results within +/- 20% | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With and Without Diabetes | Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. |
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| Secondary | Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15% of Laboratory Glucose Method When Obtained and Tested by Study Staff | Study staff obtained and tested subject (WITH and 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 capillary plasma results were used to calculate the number of BGMS results within +/-15% across the tested YSI glucose range. | 369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation. | Posted | | Number | | Blood glucose results within +/- 20% | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With and Without Diabetes | Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. |
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| Secondary | Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 20% of Laboratory Glucose Method When Obtained and Tested by Study Staff | Study staff obtained and tested subject (WITH and 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 capillary plasma results were used to calculate the number of BGMS results within +/-20% across the tested YSI glucose range. | 369 (372-3) Blood glucose results were analyzed. One (1) subject had no hematocrit result, required per protocol. For one subject staff test was not performed and for one subject staff test was not evaluable due to protocol deviation. | Posted | | Number | | Blood glucose results within +/- 20% | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With and Without Diabetes | Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. |
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| Secondary | Number of Subject Responses That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | Staff obtained responses from subjects 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 'Neutral' or 'Disagree' or 'Strongly Disagree.' | | Posted | | Number | | Number who strongly agree,agree,neutral | | 1 hour | | | | ID | Title | Description |
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| OG000 | Persons With and Without Diabetes | Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma. |
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