Product Info

Table E-9: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Day 1; Calibration 3 or 4 times a day, Buttock
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YSI
Percent of SG
Within 15/15% of
YSI
Percent of SG
Within 20/20% of
YSI
Percent of SG
Within 30/30% of
YSI
Percent of SG
Within 40/40% of
YSI
Percent of SG
greater than
40/40% of YSI
Overall 311 80.7 90.4 95.5 98.7 1.3
>60-80* 13 69.2 76.9 100 100 0
>80-180 159 77.4 86.8 92.5 97.5 2.5
>180-300 131 87 96.2 98.5 100 0
>300-350 6 50 83.3 100 100 0
>350-400 2 100 100 100 100 0
* For glucose ranges ≤80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 13 subjects. SG readings are within 40-400 mg/dL.
Agreement when CGM reads “Below 40 mg/dL” or “Above 400 mg/dL”
The real-time CGM systems display glucose values between 40 mg/dL and 400
mg/dL. It displays “Below 40 mg/dL” when the SG value detected is below 40
mg/dL. It displays “Above 400 mg/dL” when the SG value detected is above 400
mg/dL. Tables E-10 through E-13 illustrate the number and percentage of the
paired YSI values in different BG levels when the CGM system displays “Below 40
mg/dL” (LOW) or “Above 400 mg/dL” (HIGH).
Table E-10: The number and percentage of YSI values collected when CGM displays "Below 40 mg/dL" (LOW); Calibration every 12 hours
CGM Readings Insertion Site CGM-YSI pairs <55 <60 <70 <80 >80 Total
LOW Abdomen Cumulative, n 2 2 2 2 0 2
Cumulative % 100% 100% 100% 100% 0%
Buttocks Cumulative, n 3 4 7 7 1 8
Cumulative % 38% 50% 88% 88% 13%
Table E-11: The number and percentage of YSI values collected when CGM displays "Below 40 mg/dL" (LOW); Calibration 3 or 4 times a
day
CGM Readings Insertion Site CGM-YSI pairs <55 <60 <70 <80 >80 Total
LOW AbdomenCumulative, n00000 0
Cumulative % 0%0%0%0%0%
Buttocks Cumulative, n34661 7
Cumulative % 43% 57% 86% 86% 14%
Table E-12: The number and percentage of YSI values collected when CGM displays "Above 400 mg/dL" (HIGH); Calibration every 12
hours
CGM Readings Insertion Site CGM-YSI pairs >340 >320 >280 >240 <240 Total
HIGH AbdomenCumulative, n000000
Cumulative %0%0%0%0%0%
ButtocksCumulative, n000000
Cumulative %0%0%0%0%0%
358 Chapter 17