Dexcom G4 Platinum User Manual page 161

16
Status Box. When the Dexcom G4 PLATINUM (Pediatric) 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 Tables 2-A
(pediatric study) and 2-B (adult study). 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").
Table 2-A. Number and Percentage of YSI Values When
CGM Readings are 'Low' or 'High'
CGM
Readings
'LOW'
CGM
Readings
'HIGH'
In the pediatric clinical study, the subject's glucose levels were
8
not intentionally manipulated during this study, so there are fewer
data samples in the low and high glucose ranges than in the adult
clinical study.
CGM-YSI < 55
pairs (3.1)
0
n
Cumulative
0%
Percent
CGM-YSI > 340
pairs (18.9)
38
n
Cumulative
54%
Percent
Dexcom G4 PLATINUM (Pediatric) System User's Guide
(Pediatric Study)
8
YSI mg/dL (mmol/L)
< 60 < 70
(3.3) (3.9)
0 0
0% 0%
YSI mg/dL (mmol/L)
> 320 > 280 > 240
(17.8) (15.6) (13.3)
51 68
73% 97%
Total
< 80 ≥ 80
(4.4) (4.4)
0 13
0% 100%
Total
≤ 240
(13.3)
69 1
99% 1%
13
70
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