User's Manual

Dexcom G5x System User Guide
Technical Information
302
The ability of the System to detect high and low glucose levels is assessed by
comparing System results to YSI results at low and high BG levels and
determining if the Alert may have sounded. The System and YSI values were
compared by pairing the System reading that occurred immediately after the
YSI value was collected. We suggest that you ask your doctor what Alert
settings would be best for you.
The Low Glucose Alert
Estimates of how well the adjustable Low Glucose Alert performs are
presented in Table 5-A, 5-B and 5-C. Table 5-A represents the hypoglycemic
Alert evaluation within 15 minutes of the YSI value in the adult studies. Table
5-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 5-C represents the Alert evaluation
within 30 minutes of an SMBG reading for 2- to 5-year-old subjects in the
pediatric studies.
Hypoglycemia 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 below
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 above the Alert setting within 15 or 30 minutes before or after the device
alarmed.
For example, if you set the Low Glucose Alert to 70 mg/dL and your Alarm
sounds, how often can you expect your blood sugar to actually be low? In the
Software 505 Adult Study (Table 5-A), when your Alarm sounds, you can
expect your blood sugar to be below 70 mg/dL approximately 92% of the time
and above 70 mg/dL approximately 8% of the time within the 15 minute period
before or after your Alarm sounds.
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor