Dexcom G4 Platinum User Manual page 167

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Table 4-B. System Difference to YSI within CGM
Glucose Ranges (Adult Study)
CGM
Glucose
Ranges
mg/dL
(mmol/L)
Overall
*40-60
(2.2-3.3)
*61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
* F or CGM ≤ 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L)
are included instead of percent differences (%).
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Low and High Glucose Alerts
The ability of the System to detect high and low glucose levels
(concentrations) is assessed by comparing System results to YSI results
at low and high blood glucose levels and determining if the alert may
have sounded. The System and YSI readings were compared by pairing
Mean
Number
Percent
of paired
Difference
CGM-YSI
(%)
9152 2.9
-10.0
512
(-0.6)
-2.4
781
(-0.1)
3853 4.8
2784 2.1
775 3.8
447 10.4
Dexcom G4 PLATINUM (Pediatric) System User's Guide
Mean
Median
Absolute
Percent
Percent
Difference
Difference
(%)
(%)
1.7 13.3
-8.2 13.5
(-5.2) (0.8)
-0.4 11.4
(-0.0) (0.6)
3.0 13.8
0.0 11.9
2.8 9.8
7.7 12.8
Median
Absolute
Percent
Difference
(%)
9.8
9.7
(0.5)
8.6
(0.5)
9.8
9.2
7.9
9.1
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