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Section 18

Appendix B: Specifications

18 Appendix B: Specifications (con’t)

Performance Relative to the Reference (YSI)

Error grid analysis (like the Clarke Error Grid Analysis and Continuous Glucose-Error Grid Analysis) is one way to evaluate the accuracy of the FreeStyle Navigator system. The accuracy can also be assessed by analyzing the difference in the glucose results from the FreeStyle Navigator system when compared to the results from the YSI. Table 4a shows an analysis of the measure of closeness of the FreeStyle Navigator system to the YSI. It breaks the data into smaller groups based on the glucose value reported by the YSI. The table reports the mean absolute difference for the data pairs in each of the smaller groups. Table 4b shows the same data at different levels of glucose and further groups them by the amount of difference from the YSI. Table 5 breaks out the overall performance relative to the YSI for the two sites of sensor insertion.

The overall median absolute relative difference for all the data pairs is 9.3%.

Table 4a. Performance relative to YSI at different glucose levels

Glucose (mg/dL)

Performance

 

 

20-40

Mean Absolute Difference = 32.3 mg/dL

 

 

41-80

Mean Absolute Difference = 18.1 mg/dL

 

 

81-120

Mean Absolute Difference = 16.3 mg/dL

 

 

121-240

Mean Absolute Relative Difference = 11.0%

 

 

>240

Mean Absolute Relative Difference = 9.5%

 

 

Table 4b. Performance relative to YSI at different levels of glucose – grouped by amount of difference from the YSI

Glucose Range

Number of

Percent Within

Percent Within

Percent Within

(mg/dL)

Paired Readings

20% of the YSI

30% of the YSI

40% of the YSI

20-40*

22

31.8

54.5

72.7

41-80*

1295

65.9

82.0

90.7

81-120

3820

69.5

85.2

92.7

121-240

11430

85.4

95.1

98.3

>241

3795

91.7

98.8

99.9

Overall

20362

82.3

93.1

97.0

*The absolute difference from the YSI reading is measured in mg/dL if the YSI reading is 20-80 mg/dL.

Table 5. Performance relative to YSI at different insertion sites

Overall MeanAbsolute

MARD by Insertion Site

 

 

RelativeDifference

Abdomen

Arm

 

 

 

 

12.8% (Std. Dev. = 13.6%)

13.1%

12.6%

 

 

 

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Arkon PRT03831-xxx manual Performance Relative to the Reference YSI, Glucose mg/dL Performance
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PRT03831-xxx specifications

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