User`s guide

136 | Dexcom G4 Continuous Glucose Monitoring System
11
Number of Readings Provided
The System is capable of providing a reading up to every 5 minutes, or up to
288 readings per day. For a variety of reasons, the System may not display
a glucose reading and readings are “skipped.” Table 7 estimates the number
of readings you can expect to receive from the System over the entire 7-day
period after calibration. For example, 93% of Systems provided between 1,707
and 1,992 valid glucose readings (or more than 76% of the expected number
of readings). Adjusted within each system wear day, the System provided an
average of 96% of all expected glucose readings (288) as seen in Table 8.
Agreement and Accuracy at Home
During the study, agreement between the System and blood glucose values
is also characterized using paired System and SMBG results. The System
and SMBG values were compared by pairing the comparative SMBG value
to a System glucose reading that occurred immediately after the SMBG was
collected. These results present the performance patients expect during real
time use of the system in their daily diabetes management when comparing the
system readings to their home blood glucose meter results.
Table 7. Number of Readings Provided by Each Sensor over 7-Days
% of Total Possible
Readings Provided
Total Readings Provided
% of System Devices
Providing that number of
readings
0-25% N/A 0%
26-50% 976-981 5%
51-75% 1013-1013 2%
76-100% 1707-1992 93%
Table 8. System Readings within Wear Days
Statistic Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
All
Days
(N=42)
Mean 90% 99% 99% 96% 99% 98% 91% 96%
Median 91% 100% 100% 100% 100% 100% 97% 99%
STD 2% 1% 1% 10% 2% 7% 16% 8%