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The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intended Users of the System | Experimental | Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ninja 2 Investigational Blood Glucose Monitoring System | Device | The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma). | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the YSI capillary plasma reference method results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Simmons, MD | Ascensia Diabetes Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayer HealthCare LLC, Diabetes Care | Mishawaka | Indiana | 46544 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intended Users of the System | Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm. Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intended Users of the System | Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm. Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma). | 110 subjects tested one of 3 test strip lots on the BGM system. 110 (1x110) test results are available. | Posted | Number | participants | 1 hour |
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Each subject participated for 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 | Intended Users of the System | Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm. Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace | 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the YSI capillary plasma reference method results. | One subject had low blood sugar. The protocol (and User Guide) do not allow alternative site testing when blood sugar is low. The remaining 109 subjects tested one strip lot on the BGM system. 109 test results were available. | Posted | Number | participants | 1 hour |
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| 0 |
| 110 |
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| 110 |
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| # within +/- 5mg/dL(<75mg/dL) or 5% (>=75mg/dL) |
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