User`s guide

Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 159
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
classied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’
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(Pediatric Study)
YSI mg/dL (mmol/L)
Total
CGM
Readings
CGM-YSI
pairs
< 55
(3.1)
< 60
(3.3)
< 70
(3.9)
< 80
(4.4)
≥ 80
(4.4)
‘LOW’
n
0 0 0 0 13 13
Cumulative
Percent
0% 0% 0% 0% 100%
YSI mg/dL (mmol/L)
Total
CGM
Readings
CGM-YSI
pairs
> 340
(18.9)
> 320
(17.8)
> 280
(15.6)
> 240
(13.3)
≤ 240
(13.3)
‘HIGH’
n
38 51 68 69 1 70
Cumulative
Percent
54% 73% 97% 99% 1%
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In the pediatric clinical study, the subject’s glucose levels were
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.