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Guardian RT sensor performance and calibration stability as a function

of time

The Guardian R

T 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 A216

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