User's Manual

87
Advanced Study (SW10505)
: The total number of data pairs considered in the analysis was 2263. Of
these, 93% of the System readings fall within ± 20 mg/dL of the YSI blood glucose values ≤ 80 mg/dL and
within ± 20% of YSI blood glucose values > 80 mg/dL.
Table 2. Number and Percentage of YSI Values When CGM Readings are “Low” or
“High”
YSI mg/dL
Total
CGM
Readings
Study
1
CGM-YSI pairs < 55 < 60 < 70 < 80 ≥ 80
“LOW”
Original
n 66 84 123 142 13 155
Cumulative Percent 42% 54% 79% 92% 8%
Advanced
n 11 16 17 18 0 18
Cumulative Percent 61% 89% 94% 100% 0%
YSI mg/dL
Total
CGM
Readings
Study
1
CGM-YSI pairs > 340 > 320 > 280 > 240 ≤ 240
“HIGH”
Original
n 189 220 238 246 2 248
Cumulative Percent 76% 89% 96% 99% 1%
Advanced
n 40 43 45 45 0 45
Cumulative Percent 89% 96% 100% 100% 0%
1
Both sets of study data are presented and are labeled as
Original
(SW10050) or
Advanced
(SW10505).
Agreement When CGM Reads “LOW” or “HIGH”
The System reports glucose readings between 40 and 400 mg/dL. When the System determines the glucose
reading is below 40 mg/dL, it displays “LOW” in the Receiver Status Box. When the Dexcom G4 PLATINUM
System determines that the glucose level is above 400 mg/dL, it displays “HIGH” in the Receiver Status
Box. Because the System does not display glucose values below 40 mg/dL or above 400 mg/dL, the
comparisons to the actual blood glucose levels (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”).
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.
ADVANCED 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.