Dexcom G4 Platinum User Manual page 178

14
Table 11 is categorized within CGM glucose ranges. For readings
less than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference
in mg/dL (mmol/L) between the two glucose results was calculated.
For values greater than 80 mg/dL (4.4 mmol/L) the absolute percent
difference (%) from the SMBG values was calculated. The percentages
of total readings within 15 mg/dL (0.8 mmol/L) or 15%, 20 mg/dL (1.1
mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL (2.2 mmol/L)
or 40% or greater than 40 mg/dL (2.2 mmol/L) or 40% were then
calculated.
Table 12. System Difference to SMBG within CGM
Glucose Ranges (Pediatric Study)
CGM Glucose
Ranges mg/dL
(mmol/L) CGM-SMBG
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.
176 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
Mean
Number
Percent
of Paired
Difference
(%)
16318 2.2
487 -22.1 (-1.2) -17.0 (-0.9)
1340 -11.8 (-0.7)
7084 1.1
5627 5.7
1176 9.6
604 12.7
Mean
Median
Absolute
Percent
Percent
Difference
Difference
(%)
(%)
0.9 15.3
23.9 (1.3)
-8.0 (-0.4) 17.0 (0.9)
-1.0 15.4
3.4 13.5
7.2 14.2
10.2 16.1
Median
Absolute
Percent
Difference
(%)
11.1
18.0 (1.0)
11.0 (0.6)
11.4
9.5
10.4
11.9