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The purpose of this study was to determine if untrained subjects with diabetes can operate the Investigational ONYX PLUS Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Users of the Monitoring System | Experimental | Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONYX PLUS Investigational Blood Glucose Monitoring System | Device | Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 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 percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma). | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with 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 +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma). |
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Inclusion Criteria:
Exclusion Criteria:
The enrollment goal for the intended use population:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute Inc. | Principal Investigator |
| Mark Christiansen, MD | Diablo Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States | ||
| Diablo Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Users of the Monitoring System | Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System. ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Users of the Monitoring System | Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System. ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | 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 percent of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma). | Posted | Number | Percentage of BG Results | 1 hour |
|
Subject visits were approximately 1 hour.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Users of the Monitoring System | Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System. ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Subjects' hypoglycemia were resolved at the visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace, Deputy Director for Global Clinical Affairs | Ascensia Diabetes Care | 574-257-3063 | jane.wallace@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| 1 hour |
| Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff | Study staff tested subject 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 +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma). | 1 hour |
| Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject venous 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 +/- 15mg/dL (<100mg/dL YSI venous plasma) and +/- 15% (>= 100mg/dL YSI venous plasma). | 1 hour |
| Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method | 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 percent of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) and +/- 12.5% (>= 100mg/dL YSI capillary plasma). | 1 hour |
| Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | Staff obtained responses from persons with 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'. The percent of subjects who provided responses that were 'Strongly Agree','Agree','Neutral' about each statement was calculated. | 1 hour |
| 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 | 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 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'No Answer or Not Applicable'. The percents (of subjects who responded) that were 'Strongly Agree','Agree','Neutral' about views/behaviors related to self-monitoring blood glucose were calculated. | 1 hour |
| Walnut Creek |
| California |
| 94598 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Subjects provided more than one choice for Race. Therefore, the apparent frequency total for Race was different from the number of subjects. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Percent of Alternate Site Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Untrained subjects with 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 +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma). | 126 (134-8) Blood glucose results were analyzed. Four subjects with low blood sugar did not attempt palm testing per protocol. Four subjects had low blood sugar; their palm results were not evaluable per protocol. | Posted | Number | Percentage of BG Results | 1 hour |
|
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| Secondary | Percent of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method When Tested by Study Staff | Study staff tested subject 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 +/- 15mg/dL (<100mg/dL YSI capillary plasma) and +/- 15% (>= 100mg/dL YSI capillary plasma). | Posted | Number | Percentage of BG Results | 1 hour |
|
|
|
| Secondary | Percent of Venous Blood Glucose (BG) Results Within +/- 15mg/dL (<100mg/dL) and Within +/- 15% (>=100mg/dL) of Laboratory Glucose Method | Study staff tested subject venous blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject venous 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 +/- 15mg/dL (<100mg/dL YSI venous plasma) and +/- 15% (>= 100mg/dL YSI venous plasma). | 132 (134-2) Blood glucose results were analyzed. Venipunctures were unsuccessful for two subjects. | Posted | Number | Percentage of BG Results | 1 hour |
|
|
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| Secondary | Percent of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 12.5mg/dL (<100mg/dL) and Within +/- 12.5% (>=100mg/dL) of Laboratory Glucose Method | 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 percent of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) and +/- 12.5% (>= 100mg/dL YSI capillary plasma). | Posted | Number | Percentage of BG Results | 1 hour |
|
|
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| Secondary | Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding BGMS | Staff obtained responses from persons with 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'. The percent of subjects who provided responses that were 'Strongly Agree','Agree','Neutral' about each statement was calculated. | Posted | Number | Percentage of Participants Who Responded | 1 hour |
|
|
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| Secondary | 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 | 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 'Neutral' or 'Disagree' or 'Strongly Disagree' or 'No Answer or Not Applicable'. The percents (of subjects who responded) that were 'Strongly Agree','Agree','Neutral' about views/behaviors related to self-monitoring blood glucose were calculated. | Percent (of those who responded) who 'Strongly Agree', 'Agree', 'Neutral' was calculated for each statement. Abbreviations used: 'HCP' is HealthCare Professional and 'Acc' is Accuracy | Posted | Number | Percentage of Participants Who Responded | 1 hour |
|
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| 0 |
| 134 |
| 4 |
| 134 |
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| Title | Measurements |
|---|---|
|
| I like the overall meter design. |
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| I find the meter easy to use. |
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| The instructions were easy to understand. |
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| Instructions clearly explain how to run a test. |
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| Instructions clearly explain meter error messages. |
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| Title | Measurements |
|---|---|
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| Acc:important to help prevent low blood sugar |
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| Acc:important to understand food/exercise effects. |
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| Acc:help w using results to better control diabete |
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| Acc:important to achieve greater peace of mind. |
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| I prefer the meter I just used to my regular meter |
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| I use my meter - my care provider gave it to me. |
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| I use my current meter -my insurance covers strips |
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| I use my current meter-I think it is most accurate |
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