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Guardian RT sensor performance and calibration stability as a function of

time

The Guardian RT sensor may be worn for up to 3 days (72 hours) and must be calibrated at least twice a day.

Two sets of data, approximately equal in number, were collected during the clinical trial. One data set was

generated when the frequency of calibrations averaged 3.5 per day (Data Set A), and the other averaged 5

times a day (Data Set B). During the study, a total of 38 sensors were evaluated in 16 individuals.

As per the stratified Clarke Error Grid analysis above, agreement between Guardian RT values and YSI values

tends to be less at low and high glucose concentrations when compared to other concentration ranges.

Guardian RT performance in the hypoglycemic range, as a function of sensor insertion time, is characterized

below. Results from the two different data sets are presented. The two populations were separated according

to the number of calibrations per day. This table represents the percentage of Data Points in the 2.2 - 4.4

mmol/L (40-80 mg/dL) range that fell within 1.1 mmol/L (20 mg/dL). Data is presented in 12-hour

increments.

Data Set

0-12 hrs 12-24 hrs 24-36 hrs 36-48 hrs 48-60 hrs 60-72 hrs

A 78% 81% 73% 65% 56% 41%

B 67% 70% 93% 60% 75% 38%

Appendix A

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Medtronic Paradigm Link Uživatelská příručka Strana 235