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Low and High Alerts in children and adolescents

The ability of the Guardian RT to detect high and low glucose levels was measured in the same clinical study.

Since it is important to set the alert levels in a conservative fashion, the Low Glucose Alert should be set at

a value slightly higher than the value of blood glucose you want to detect, and the High Glucose Alert should

be set at a value slightly lower than the value of blood glucose you want to detect.

NOTE: Please ask your healthcare professional which low and high alert setting is best for you.

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The Low Glucose Alert

The Low Glucose Alert was evaluated for its ability to detect glucose levels at 70 mg/dL (3.9 mmol/L), or

below, using the blood glucose meter. As a reference, with the Low Glucose Alert set at 70 mg/dL (3.8

mmol/L), 24% (59/244) of low glucose events were detected by the Guardian RT. Better detection of low

blood glucose can be obtained by setting the Low Glucose Alert level higher. For example, setting the Low

Glucose Alert at 90 mg/dL (5.0 mmol/L), instead of 70 mg/dL (3.9 mmol/L), increases the ability to detect

low blood glucose levels from 24% to 70% (see the following table).

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

Alert was set at 70 mg/dL (3.9 mmol/L) in this study, 48% of the results were considered false alerts (actual

blood glucose values are greater than 85 mg/dL (4.7 mmol/L)). This percentage may be exaggerated because

blood glucose may be dropping when the Guardian RT alerts.

The table below shows the percent of Low Glucose readings correctly identified by the Guardian RT for

specific settings.

Guardian RT Low Alert

Setting (mg/dL)

Guardian RT Low Alert

Setting (mmol/L)

True Alert Rate* False Alert Rate**

70 3.9 24% 48%

80 4.4 52% 46%

90 5.0 70% 52%

100 5.6 85% 57%

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

sounded.

** False Alerts Rates are the % of times when the Guardian RT Sensor alarmed but the blood glucose level

was greater than the alert setting.

Sensor accuracy

227

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