User`s guide
Dexcom G4 PLATINUM User’s Guide | 157
System does not display glucose values below 40 mg/dL or above
400 mg/dL, the comparisons to the actual blood glucose levels (as
determinedbytheYSIanalyzer)whenCGMisclassiedas“LOW”
or “HIGH” are included separately in Table 2. The table includes the
numbers and the cumulative percentages when YSI values were less
than certain glucose levels (for “LOW”), and when YSI values were
greater than certain glucose levels (for “HIGH”).
Original Study (SW10050): When the System displayed “LOW” (155
occasions), 92% (142 out of 155) of the YSI values were less than 80
mg/dL, and only 79% (123 out of 155) of the YSI values were less than
70 mg/dL. When the System displayed “HIGH” (248 occasions), 99%
(246 out of 248) of the YSI values were greater than 240 mg/dL, and
96% (238 out of 248) of the YSI values were greater than 280 mg/dL.
Software 505 Study (SW10505): When the System displayed “LOW”
(18 occasions), 100% (18 out of 18) of the YSI values were less than
80 mg/dL, and 94% (17 out of 18) of the YSI values were less than 70
mg/dL. When the System displayed “HIGH” (45 occasions), 100% (45
out of 45) of the YSI values were greater than 240 mg/dL, and 100% (45
out of 45) of the YSI values were greater than 280 mg/dL.