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Table H-5: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing Day 1;
Calibration 3 or 4 times a day, Abdomen
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YS
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
Within >40/40%
of YSI
*For glucose ranges ≤ 80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: Sensor glucose readings are within 40-400 mg/dL.
Note: For the blank Cells (-), there are no paired points in this reference range.
Table H-6: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing (FST) Days 1,
3, and 7; Calibration every 12 hours, Buttock
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YS
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
Within >40/40%
of YSI
Overall 195 81.5 88.7 97.4 98.5 1.5
≥40-60* 2 50 50 50 100 0
>60-80* 12 75 83.3 91.7 91.7 8.3
>80-180 99 78.8 85.9 97 98 2
>180-300 73 84.9 93.2 100 100 0
>300-350 8 100 100 100 100 0
>350-400 1 100 100 100 100 0
*For glucose ranges ≤ 80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: Sensor glucose readings are within 40-400 mg/dL.
Table H-7: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing (FST) Day 1;
Calibration every 12 hours, Buttock
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YS
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
Within >40/40%
of YSI
Overall 93 71 83.9 96.8 97.8 2.2
≥40-60* 1 100 100 100 100 0
>60-80*107080909010
>80-180 46 63 78.3 95.7 97.8 2.2
>180-300 31 77.4 90.3 100 100 0
>300-350 4 100 100 100 100 0
>350-400 1 100 100 100 100 0
*For glucose ranges ≤ 80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: Sensor glucose readings are within 40-400 mg/dL.
Table H- 8: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing (FST) Days
1, 3, and 7; Calibration 3 or 4 times a day, Buttock
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YS
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
Within >40/40%
of YSI
Overall 159 84.3 88.7 96.2 97.5 2.5
≥40-60* 2 50 50 50 50 50
670G Performance Data and Technical Information
670G Performance Data and Technical Information 381