User's Manual
86
Table 1. System Agreement to YSI within CGM Glucose Ranges
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 9152 71% 82% 92% 3%
Advanced 2263 86% 93% 98% 1%
40-60
Original 512 67% 78% 88% 6%
Advanced 120 89% 94% 98% 0%
61-80
Original 781 73% 85% 94% 2%
Advanced 226 91% 96% 99% 0%
81-180
Original 3853 67% 78% 91% 3%
Advanced 738 84% 92% 98% 1%
181-300
Original 2784 72% 84% 93% 4%
Advanced 798 86% 93% 98% 1%
301-350
Original 775 82% 91% 97% 2%
Advanced 229 86% 94% 98% 1%
351-400
Original 447 74% 84% 91% 5%
Advanced 152 80% 92% 97% 0%
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
Advanced
(SW10505).
AGREEMENT RELATIVE TO YSI
Agreement between the System and blood glucose values is characterized using paired System and YSI
values. The System and YSI results were compared by pairing the YSI blood glucose value to a System
glucose reading that occurred immediately after the YSI was collected.
The agreement of the System to blood glucose 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 was
calculated. The percentages of total readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or
30% or greater than 40 mg/dL or 40% were then calculated in Table 1. TABLE 1 IS CATEGORIZED
WITHIN CGM GLUCOSE RANGES. WHEN YOU SEE A CGM READING ON YOUR RECEIVER, THIS
TABLE SHOWS YOU HOW LIKELY THAT READING MATCHES YOUR BLOOD GLUCOSE LEVEL
(MEASURED BY YSI IN THE STUDY).
Original Study (SW10050)
: The total number of data pairs considered in the analysis was 9152. Of
these, 82% of the System readings fall within ± 20 mg/dL of the YSI blood glucose values ≤ 80 mg/dL and
within ± 20% of YSI blood glucose values > 80 mg/dL.