Dexcom G4 Platinum User Manual page 162

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Table 2-B. Number and Percentage of YSI Values When
CGM Readings are 'Low' or 'High'
CGM CGM-YSI
Readings pairs
'LOW'
Cumulative
Percent
CGM CGM-YSI
Readings pairs
'HIGH'
Cumulative
Percent
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.
In the pediatric clinical study, the subject's glucose levels were
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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.
160 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
< 55
(3.1)
64
n
41%
> 340 > 320
(18.9) (17.8)
189
n
76%
(Adult Study)
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YSI mg/dL (mmol/L)
< 60 < 70 < 80
(3.3) (3.9) (4.4)
82 122 142
53% 79% 92%
YSI mg/dL (mmol/L)
> 280 > 240
(15.6) (13.3)
220 238 246
89% 96% 99%
Total
≥ 80
(4.4)
13 155
8%
Total
≤ 240
(13.3)
2 248
1%