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Performance results in children and adolescents

The performance of the Guardian RT in Children and Adolescents was evaluated in a clinical study. Guardian

RT results were compared to capillary blood glucose measured by a LifeScan OneTouch

Ultra

Meter. Sixty

subjects with Type I diabetes participated in a three-site out-patient study. Subjects ranged in age from 7

to 17 years old. Each subject wore a Guardian RT system, which records a sensor glucose value every five

minutes. Subjects were instructed to perform at least seven blood glucose meter measurements each day.

Accuracy of Guardian RT readings

In this study, each blood glucose meter measurement was paired with the corresponding Guardian RT reading

(taken every 5 minutes). Pairing was done by selecting the Guardian RT value closest in time to the blood

glucose meter result. Agreement was analyzed by comparing paired glucose measurements.

Agreement between the matched pair was estimated by evaluating the difference between the Guardian RT

reading and the blood glucose meter measurement. The difference between them was calculated as a

percentage of the blood glucose meter measurement (Mean Absolute Percent Difference). The bias was also

calculated, and it is defined as the overall difference between the Guardian RT glucose values and the blood

glucose meter values. The paired glucose measurements are summarized in the following table

Number of Paired Glucose Measurements

2599

Mean Absolute Percent Difference (± SD) 19.0 ± 19.7%

Bias -6.0 mg/dL (-0.3 mmol/L)

Sensor accuracy

223

ಘAppendix A

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