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Increasing the Low Alert settings will improve the ability to detect low blood glucose events, but it will

also increase the frequency of Guardian R

T false alerts for blood glucose levels not below the target value.

You should consider this trade-off between the improved ability to detect true low blood glucose versus

the increased number of false alerts when setting the low alert threshold.

The High Glucose Alert

The High Glucose Alert was evaluated for its ability to detect glucose levels at 250 mg/dL (13.8 mmol/L),

or above, using the YSI analyzer. As a reference, with the High Glucose Alert set at 250 mg/dL (13.8

mmol/L), 53% (195/365) of high glucose events were detected by the Guardian RT. Better detection of

high blood glucose can be obtained by setting the High Glucose Alert level lower. For example, setting the

High Glucose Alert at 190 mg/dL (10.6 mmol/L), instead of 250 mg/dL (13.8 mmol/L), increases the ability

to detect high blood glucose levels from 53% to 85% (see the table below).

Sometimes the Guardian RT will alert when the blood glucose levels are not high. When the Guardian RT

High Alert was set at 250 mg/dL (13.8 mmol/L) in this study, 7.2% of the results were considered false

alerts (actual blood glucose values are less than 225 mg/dL (12.5 mmol/L)). This percentage may be

exaggerated because blood glucose may be rising when the Guardian RT alerts. The table below shows the

percent of High Glucose readings correctly identified by the Guardian RT for specific settings.

Guardian RT High Alert

Setting (mg/dL)

Guardian RT High Alert

Setting (mmol/L)

True Alert Rate* False Alert Rate**

190 10.6 85% 64%

200 11.1 81% 58%

225 12.5 67% 40%

250 13.8 53% 25%

* True Alert Rates are the % of times when the glucose level was at or above the alert setting and the alert

sounded.

** False Alerts Rates are the % of times when the Guardian R

T Sensor alarmed but the blood glucose level

was lower than the alert setting.

Decreasing the High Alert settings will improve the ability to detect high blood glucose events, but it will

also increase the frequency of Guardian RT false alerts for blood glucose levels not above the target value.

You should consider this trade-off between the improved ability to detect true high blood glucose versus

the increased number of false alerts when setting the high alert threshold.

Sensor accuracy 215

Appendix A

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