Dexcom G4 PLATINUM User Manual page 99

the System provided an average of 98% of all expected glucose readings (288) as seen in Table
Advanced
10.
Table 11. CGM System Agreement to SMBG within CGM Glucose Ranges
CGM
Glucose
Study
2
Ranges
1
(mg/dL)
Original
Overall
Advanced
Original
40-60
Advanced
Original
61-80
Advanced
Original
81-180
Advanced
Original
181-300
Advanced
Original
301-350
Advanced
Original
351-400
Advanced
1
CGM readings are within 40 to 400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as
Agreement and Accuracy Relative to SMBG
During the study, agreement between the System and blood glucose values is also characterized using
paired System and SMBG results. The System and SMBG values were compared by pairing the
comparative SMBG value to a System glucose reading that occurred immediately after the SMBG was
collected. These results characterize the performance subjects expect during real-time use of the System in
their daily diabetes management when comparing the System readings to their home blood glucose meter
results.
Table 11 is categorized within CGM glucose ranges. For readings less than or equal to 80 mg/dL the
absolute difference in mg/dL between the two glucose results was calculated. For values greater than 80
mg/dL the absolute percent difference (%) from the SMBG values was calculated. The percentages of total
readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% or greater than 40
mg/dL or 40% were then calculated. For example, if the CGM reads 100 mg/dL, it is between 81-180 mg/dL
Percent Percent
Number of
within
paired
15/15% 20/20%
CGM-SMBG
SMBG
7508 69%
2992 77%
731 75%
221 73%
968 78%
336 77%
3141 65%
1362 74%
1960 68%
826 80%
450 77%
161 83%
258 75%
86 90%
Percent
Percent
greater
within within
than
30/30%
40/40%
SMBG SMBG
SMBG
81% 94% 2%
87% 96% 1%
84% 92% 4%
80% 87% 7%
86% 95% 1%
85% 95% 1%
78% 93% 2%
85% 96% 1%
81% 94% 3%
90% 97% 1%
88% 98% 1%
93% 99% 0%
85% 95% 2%
93% 98% 1%
(SW10050) or
Original
99
(SW10505).
Advanced