Dexcom SEVEN PLUS User Manual page 117

Calibrations Stability
The SEVEN PLUS must be calibrated every 12 hours. To demonstrate performance of the SEVEN
PLUS over a 12-hour calibration period, 71 Sensors were evaluated to verify that performance
remains consistent over the 12-hour calibration period. SEVEN PLUSs were evaluated in 3-hour
increments after calibration. Performance was estimated at each 3-hour interval and stratified by
glucose concentrations by calculating the percentage of SEVEN PLUS readings within 20%, 30% and
greater than 40% of the YSI readings. See the table below.
Percentage of SEVEN PLUS readings within 20%, 30% and 40% of the YSI Laboratory
Table 8.
reading with data stratified in 3-hour increments after calibration across days 1, 4 and 7.
Time from
Calibration and YSI
Glucose Range
(40-400 mg/dL)
0-3 hours
3-6 hours
6-9 hours
9-12 hours
Sensor Stability
Sensors can be worn for up to 7 days. To verify that sensors perform consistently over the 7-day period,
71 Sensors were evaluated across the 7-day wear period. Performance was estimated by calculating
the percentage of SEVEN PLUS readings within 20%, 30% and >40% of the YSI readings at the begin-
ning (Day 1), middle (Day 4) and end (Day 7) of the SEVEN PLUS lifecycle. Results are shown in the
table below.
SEVEN PLUS System Sensor Stability (Accuracy Over Time)
Table 9.
Day of Wear Number
(40-400 of Paired
mg/dl) Readings
Day 1 637
Day 4 635
Day 7 533
Number % of Readings
of Paired within 20%
Readings of YSI
1031 77%
345 75%
235 71%
187 77%
% of Readings
within 20%
of YSI
77%
80%
70%
% of
Readings Readings
within 30% within 40%
of YSI
91%
91%
88%
88%
% of Readings % of Readings
within 30% within 40%
of YSI of YSI
91%
94%
86%
SEVEN PLUS User's Guide
% of
of YSI
96%
96%
94%
91%
3%
3%
8%
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