Dexcom G4 Professional User Manual page 188

level. For example if you feel normal and your blood glucose level is at
100 mg/dL (5.6 mmol/L), you can expect your CGM reading to be within
20% of YSI values, i.e. 80 to 120 mg/dL (4.5-6.7 mmol/L), 76% of the time.
During the clinical study, the reference YSI values outside of the
System measurable range were collected. Among these samples, on 22
occasions, when the actual blood glucose concentrations (as determined
by the YSI analyzer) were lower than 40 mg/dL (2.2 mmol/L), 73% of the
paired CGM glucose readings were within 20 mg/dL (1.1 mmol/L) of the
YSI values, and 86% of the paired CGM glucose readings were within
30 mg/dL (1.7 mmol/L) of the YSI values. On 37 occasions, when the
actual blood glucose concentration (as determined by the YSI analyzer)
were greater than 400 mg/dL (22.2 mmol/L), 86% of paired System
readings were within 20% of the YSI values, and 100% of the paired
CGM glucose readings were within 30% of the YSI values.
Agreement When CGM Reads "LOW" or "HIGH"
The System reports glucose concentrations between 40 and 400 mg/dL
(2.2-22.2 mmol/L). When the System determines the glucose level is
below 40 mg/dL (2.2 mmol/L), it displays "LOW" in the Receiver Status
Box. When the Dexcom G4 PLATINUM System determines that the
glucose level is above 400 mg/dL (22.2 mmol/L), it displays "HIGH"
in the Receiver Status Box. Because the System does not display
glucose values below 40 mg/dL (2.2 mmol/L) or above 400 mg/dL (22.2
mmol/L), the comparisons to the actual blood glucose concentrations
(as determined by the YSI analyzer) when CGM is classified as "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').
For example, on 155 occasions, the System displayed "LOW", 92% (141
out of 155) of YSI values were less than 80 mg/dL (4.4 mmol/L), and
only 79% (123 out of 155) of the YSI values were less than 70 mg/dL
(3.9 mmol/L); On 248 occasions, the System displayed "HIGH", 99%
(246 out of 248) of the YSI values were greater than 240 mg/dL (13.3
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