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Table B-2: Overall agreement (%) of SG-YSI paired points within SG ranges on FST Days 1, 3, and 7; Calibration every 12 hours,
Abdomen.
SG ranges (mg/dL) Number of paired
SG-YSI
Percent of YSI
within 15/15% of
SG (%)
Percent of YSI
within 20/20% of
SG (%)
Percent of YSI
within 30/30% of
SG (%)
Percent of YSI
within 40/40% of
SG (%)
Percent of YSI
greater than
40/40% of SG (%)
>180–300 2833 80.8 90 97.1 98.9 1.1
>300–350 286 86.4 95.1 99.7 100 0
>350–400 71 93 100 100 100 0
* For reference range ≤80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: SG Readings are within 40–400 mg/dL.
Table B-3: Agreement (%) of SG paired points within SG ranges on FST Day 1; Calibration every 12 hours, Abdomen.
SG ranges (mg/dL) Number of paired
SG-YSI
Percent of YSI
within 15/15% of
SG (%)
Percent of YSI
within 20/20% of
SG (%)
Percent of YSI
within 30/30% of
SG (%)
Percent of YSI
within 40/40% of
SG (%)
Percent of YSI
greater than
40/40% of SG (%)
Overall 4294 65.3 76.6 89.5 94.7 5.3
≥40–60* 278 46.8 61.9 83.5 94.2 5.8
>60–80* 4746171.78893.56.5
>80–180 2443 64.9 75.4 87.6 93.2 6.8
>180–300 985 71.6 83.8 95.5 98.5 1.5
>300–350 90 82.2 95.6 100 100 0
>350–400 24 91.7 100 100 100 0
* For reference range ≤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 88 subjects. SG Readings are within 40–400 mg/dL.
Table B-4: Overall agreement (%) of SG-YSI paired points within SG ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day,
Abdomen.
SG ranges (mg/dL) Number of paired
SG-YSI
Percent of YSI
within 15/15% of
SG (%)
Percent of YSI
within 20/20% of
SG (%)
Percent of YSI
within 30/30% of
SG (%)
Percent of YSI
within 40/40% of
SG (%)
Percent of YSI
greater than
40/40% of SG (%)
Overall 11664 80.6 88.9 95.9 98.2 1.8
≥40–60* 686 60.2 75.1 92 98.1 1.9
>60–80* 1303 78.7 85.7 93.5 96.7 3.3
>80–180 6549 79.9 88.5 95.7 98 2
>180–300 2782 86.4 93.5 98 99.4 0.6
>300–350 279 92.5 97.8 99.6 100 0
>350–400 65 95.4 100 100 100 0
* For reference range ≤80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: SG Readings are within 40–400 mg/dL.
Table B-5: Agreement (%) of SG paired points within SG ranges on FST Day 1; Calibration 3 or 4 times a day, Abdomen.
SG ranges (mg/dL) Number of paired
SG-YSI
Percent of YSI
within 15/15% of
SG (%)
Percent of YSI
within 20/20% of
SG (%)
Percent of YSI
within 30/30% of
SG (%)
Percent of YSI
within 40/40% of
SG (%)
Percent of YSI
greater than
40/40% of SG (%)
Overall 4136 71.4 81.9 92.3 96.3 3.7
670G Performance Data and Technical Information
670G Performance Data and Technical Information 331