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Activity Number:
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19
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 6, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #306350 |
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Title:
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System Accuracy Requirements for Blood Glucose Monitors
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Author(s):
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Nancy Schatz*+
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Companies:
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Home Diagnostics, Inc.
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Address:
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2400 NW 55th Court, Fort Lauderdale, FL, 33309,
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Keywords:
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medical devices ; blood glucose monitors ; clinical trials ; system accuracy ; ISO15197 compliance ; Parkes error grid
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Abstract:
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With the harmonized European directive, ISO EN 15197:2003, manufacturers of blood glucose monitors interested in obtaining CE marking for their products are revising their approach to clinical trials. Compliance to ISO15197 requires a different emphasis on system accuracy performance, which changes existing protocol procedures and analysis. The biggest challenge occurs with achieving the specified sample distribution in the clinical setting. The analysis is modified with specific acceptance criteria in a precise format. The talk will touch on our experience of incorporating this new directive into our clinical studies.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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