Dexcom G4 Platinum User Manual page 132

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Table 2. System Difference to YSI within YSI Glucose Ranges
YSI Glucose
Ranges mg/dL
(mmol/L)
Overall
40-80
(2.2-4.4)
*For YSI less than 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L) are included
instead of percent differences (%).
Low and High Glucose Alerts
The ability of the System to detect high and low glucose levels (concentrations)
is assessed by comparing System results to YSI results at low and high blood
glucose levels and determining if the alert may have sounded. The System
and YSI readings were compared by pairing the System reading that occurred
immediately after the YSI reading was collected. We suggest that you ask your
doctor what alert settings would be best for you.
The Low Glucose Alert
Estimates of how well the adjustable Low Glucose Alert performs are presented
in Tables 3-A and 3-B.
Table 3-A. Hypoglycemic Alert Evaluation – 15 Minutes Before and After
Hypoglycemic
True Alert
Alert Level
Rate
mg/dL (mmol/L)
55 (3.1) 50%
60 (3.3) 64%
70 (3.9) 79%
80 (4.4) 87%
90 (5.0) 90%
100 (5.6) 93%
132 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
Number of Paired Mean Absolute
System-YSI
9152
1351
Hypoglycemia
False Alert
Rate
50%
36%
21%
13%
10%
7%
Median Absolute
Difference Difference
13.3%
11.8 mg/dL 9.6 mg/dL
(0.66 mmol/L) (0.53 mmol/L)
Hypoglycemia
Detection Missed Detection
Rate Rate
71%
75%
83%
86%
89%
90%
9.8%
29%
25%
17%
14%
11%
10%