User`s guide

160 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
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Table 2-B. Number and Percentage of YSI Values When
CGM Readings are ‘Low’ or ‘High’
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(Adult 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
64 82 122 142 13 155
Cumulative
Percent
41% 53% 79% 92% 8%
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
189 220 238 246 2 248
Cumulative
Percent
76% 89% 96% 99% 1%
Concurrence of System and Laboratory Reference
The percentage of concurring CGM readings and YSI reference values
are included in Tables 3-A (pediatric study) and 3-B (adult study).
Tables 3-A (pediatric study) and 3-B (adult study) are categorized by
ranges glucose values. This table describes, for each range of CGM
glucose readings, what percentage of paired YSI values were in the
same glucose range (shaded) or in glucose ranges above and below the
paired CGM readings.
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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.