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The percentage of Guardian RT readings within 20 percent and 30 percent of YSI readings was analyzed

according to time after sensor insertion and according to the glucose-concentration range (as determined by

the YSI analyzer). See the following table.

Percentage of Guardian RT values within

20% of YSI laboratory readings

Percentage of Guardian RT values within

30% of YSI laboratory readings

Glucose Range

(mg/dl)

During first 60

hours of sensor

wear

After 60 hours of

sensor wear

During first 60

hours of sensor

wear

After 60 hours of

sensor wear

40-80

62-82% 39% 62-82% 39%

81-120 57-66% 48% 72-84% 66%

a. Agreement to within ± 1.1 mmol/L (20 mg/dL) for glucose readings  4.4 mmol/L (80 mg/dL)

Performance of the Guardian RT was evaluated according to the length of time since calibration. This data

is not conclusive because of the limited number of data points during the final 3 hours of the 12-hour

calibration cycle, i.e., 10. In contrast, 3-hour time bins, earlier in the 12-hour cycle, contained hundreds of

data points. This may suggest that calibrations are often required prior to the 12-hour calibration cycle.

Appendix A

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Medtronic Paradigm Link Podręcznik Użytkownika Strona 237