Medtronic Paradigm 522 Podręcznik Użytkownika Pobierz pdf (Strona 243)

The accuracy of the Guardian RT was also evaluated by calculating the percentage of Guardian RT readings

within 20% and within 30% of the blood glucose meter reading (or within 20 mg/dL (1.1 mmol/L) in the low

glucose range). R

esults are shown in the following table.

Plasma Glucose

Range (mg/dL)

Plasma Glucose

Range (mmol/L)

Number of Paired

Readings

Percent Within

20%

Percent Within

30%

Overall 2599 68% 82%

40-80* 2.2-4.4 360 51% ----

> 80-120 > 4.4-6.7 482 60% 77%

> 120-240 > 6.7-13.3 1055 74% 90%

> 240 > 13.3 702 75% 89%

*For the Low glucose range, 40-80 mg/dL (2.2-4.4 mmol/L), the value shown is the percent within 20

mg/dL (1.1 mmol/L).

The Clarke Error Grid was used to assess the clinical relevance of the differences between the Guardian R

readings and the comparative blood glucose meter measurements. The Clarke Error Grid divides a

correlation plot into 5 zones. See the following table.

Results in zones A and B are considered clinically acceptable, while results in zones C, D, and E are

potentially dangerous and, therefore, clinically significant errors. The Clarke Error Grid zones are labeled

on the correlation plot.

Zone Description

A Clinically accurate, would lead to correct treatment decisions

B Would lead to benign decisions or no treatment

C Would lead to over-correction of normal glucose levels

D Would lead to failure to detect and treat high or low glucose levels

E Would lead to erroneous treatment decisions

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Medtronic Paradigm 522 Podręcznik Użytkownika Strona 243