Dexcom G5 - Agreement Relative to YSI; System Agreement to YSI Within CGM Glucose Ranges (Pediatric)

Dexcom G5 Mobile System User Guide
303Technical Information
Table 1-B. System Agreement to YSI Within CGM Glucose Ranges
(Pediatric)
CGM
Glucose
Range
1
(mg/dL)
Study
2
Number
of Paired
CGM-YSI
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
Greater
Than
40/40%
YSI
Overall
Original 2922 55% 68% 85% 7%
Software 505 2262 81% 91% 96% 2%
40-60
Original 19 63% 74% 79% 21%
Software 505 86 54% 74% 91% 3%
61-80
Original 76 61% 82% 92% 4%
Software 505 142 77% 82% 90% 3%
81-180
Original 1155 56% 69% 84% 6%
Software 505 805 78% 88% 97% 1%
181-300
Original 1380 55% 68% 85% 7%
Software 505 957 89% 96% 99% 1%
301-350
Original 206 48% 62% 80% 11%
Software 505 209 81% 91% 94% 5%
351-400
Original 86 48% 61% 79% 12%
Software 505 63 64% 81% 83% 8%
1
CGM readings are within 40-400 mg/dL, inclusive.
2
Both sets of study data are presented and are labeled as Original (SW10050) or Software
505
(SW10505).
Agreement Relative to YSI
Agreement between the system and BG values is characterized using paired system and YSI values.
The system and YSI results were compared by pairing the YSI BG value to a system glucose reading
that occurred immediately after the YSI was collected.
The agreement of the system to BG value was assessed by calculating the percentage of system
readings that were within 15%, 20%, 30% and greater than 40% of the YSI values. 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 YSI values