i-SENS CareSens N Voice User Manual page 28

Precision: Precision studies were performed in a laboratory
using the CareSens N Voice BGMS.
Within Run Precision
Blood avg. 38 mg/dL
Blood avg. 86 mg/dL
Blood avg. 125 mg/dL
Blood avg. 189 mg/dL
Blood avg. 334 mg/dL
Total Precision
Control avg. 35 mg/dL
Control avg. 116 mg/dL
Control avg. 324 mg/dL
This study shows that there could be variation of up to 4.1%.
Alternative Sites Testing Evaluation
▶ Comparison of results using various AST sites with the results
of YSI measurements.
Alternative site test results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL
Fingertip 1/2 (50.0%)
1/2 (50.0%)
Forearm
2/2 (100%)
Palm
1/2 (50.0%)
Thigh
1/2 (50.0%)
Calf
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SD = 1.9 mg/dL
SD = 3.2 mg/dL
CV = 4.1%
CV = 2.6%
CV = 2.8%
SD = 1.2 mg/dL
CV = 2.4%
CV = 2.3%
Within ± 10 mg/dL Within ± 15 mg/dL
2/2 (100%) 2/2 (100%)
2/2 (100%) 2/2 (100%)
2/2 (100%) 2/2 (100%)
2/2 (100%) 2/2 (100%)
2/2 (100%) 2/2 (100%)
Alternative site test results for glucose concentration ≥ 75 mg/dL
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
Fingertip 27/48 (56.3%) 46/48 (95.8%)
Forearm 19/48 (39.6%) 42/48 (87.5%)
Palm 28/48 (58.3%) 38/48 (79.2%)
Thigh 17/48 (35.4%) 36/48 (75.0%)
Calf 27/48 (56.3%) 46/48 (95.8%)
48/48 (100%) 48/48 (100%)
47/48 (97.9%) 48/48 (100%)
46/48 (95.8%) 48/48 (100%)
46/48 (95.8%) 48/48 (100%)
48/48 (100%) 48/48 (100%)
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