User's Manual

Dexcom G5x System User Guide
Technical Information
307
The High Glucose Alert
Estimates of how well the adjustable High Glucose Alert performs are
presented in Table 6-A, 6-B and 6-C. Table 6-A represents the hyperglycemia
Alert evaluation within 15 minutes of the YSI value in the adult studies. Table
6-B represents the Alert evaluation within 15 minutes of the YSI value for a
subset of the pediatric population—subjects age 6 to 17 years who had YSI
measurements every 15 minutes. Table 6-C represents the Alert evaluation
within 30 minutes of an SMBG reading for 2- to 5-year-old subjects in the
pediatric studies.
Hyperglycemia Alert Rate
The Alert Rate shows how often the Alert is right or wrong. The True Alert
Rate is the % of time the device alarmed when the BG level was at or above
the Alert setting within 15 or 30 minutes before or after the device alarmed.
The False Alert Rate is the % of time the device alarmed when the BG level
was below the Alert setting within 15 or 30 minutes before or after the device
alarmed.
For example, if you set the High Glucose Alert to 200 mg/dL and your Alarm
sounds, how often can you expect your blood sugar to actually be high? In the
Software 505 Adult Study (Table 6-A), when your Alarm sounds, you can
expect your blood sugar to be at or above 200 mg/dL approximately 96% of
the time and not be above 200 mg/dL approximately 4% of the time within the
15 minute period before or after your Alarm sounds.
Hyperglycemia Detection Rate
The Detection Rate shows how often the device recognizes and Alerts you to
an episode of hyperglycemia or how often it misses such an event. The
Hyperglycemia Detection Rate is the % of time the BG level was at or above
the Alert setting and the device alarmed within 15 or 30 minutes before or
after the BG was at or above the Alert settings. The Hyperglycemia Missed
Detection Rate is the % of time the BG was at or above the Alert setting, but
the device did not alarm within 15 or 30 minutes before or after the BG was at
or above the Alert setting.
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