User`s guide

176 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
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)
Number
of Paired
CGM-SMBG
Mean
Percent
Difference
(%)
Median
Percent
Difference
(%)
Mean
Absolute
Percent
Difference
(%)
Median
Absolute
Percent
Difference
(%)
Overall 16318 2.2 0.9 15.3 11.1
*40-60 (2.2-3.3) 487 -22.1 (-1.2) -17.0 (-0.9) 23.9 (1.3) 18.0 (1.0)
*61-80 (3.4-4.4) 1340 -11.8 (-0.7) -8.0 (-0.4) 17.0 (0.9) 11.0 (0.6)
81-180 (4.5-10.0) 7084 1.1 -1.0 15.4 11.4
181-300
(10.1-16.7)
5627 5.7 3.4 13.5 9.5
301-350
(16.7-19.4)
1176 9.6 7.2 14.2 10.4
351-400
(19.4-22.2)
604 12.7 10.2 16.1 11.9
*For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.
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