Dexcom SEVEN PLUS - Page 117

SEVEN PLUS User’s Guide | 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 stratied 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.
Table 8. Percentage of SEVEN PLUS readings within 20%, 30% and 40% of the YSI Laboratory
reading with data stratied in 3-hour increments after calibration across days 1, 4 and 7.
Time from
Calibration and YSI
Glucose Range
(40-400 mg/dL)
Number
of Paired
Readings
% of Readings
within 20%
of YSI
% of
Readings
within 30%
of YSI
% of
Readings
within 40%
of YSI
0-3 hours 1031 77% 91% 96%
3-6 hours 345 75% 91% 96%
6-9 hours 235 71% 88% 94%
9-12 hours 187 77% 88% 91%
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.
Table 9. SEVEN PLUS System Sensor Stability (Accuracy Over Time)
Day of Wear
(40-400
mg/dl)
Number
of Paired
Readings
% of Readings
within 20%
of YSI
% of Readings
within 30%
of YSI
% of Readings
within 40%
of YSI
Day 1 637 77% 91% 3%
Day 4 635 80% 94% 3%
Day 7 533 70% 86% 8%