Dexcom SEVEN User Manual page 114

AGREEMENT USING MANUAL ENTRY FOR CALIBRATION
A separate study was conducted to evaluate Seven System Agreement to the YSI Analyzer
when using Manual Entry for calibration instead of AutoUpload for calibration. In the study
45 patients with Type 1 or Type 2 diabetes used one of the following 3 FDA-cleared blood
glucose meters for Seven System calibration: Lifescan OneTouch Ultra, Roche Accu-chek
Aviva, and Bayer Ascensia Contour.
The agreement of the Seven System to blood glucose levels when using the Manual Entry feature
for calibration was assessed by calculating the percentage of Seven System readings that were within
20%, 30%, and greater than 40% of the YSI readings on Day 4 of Sensor Wear. For readings less than
or equal to 80 mg/dL the difference in mg/dL between the two glucose readings was calculated. For
readings greater than 80 mg/dL the percent difference (%) from the YSI reading was calculated. The
percentage of total readings within 20 mg/dL or 20%, 30 mg/dL or 30%, or greater than 40 mg/dL or
40% were then calculated. The total number of data pairs considered in this analysis was 849. The
Results for each meter and when using the Manual Entry feature are shown in Table 2. Agreement
results when using only the Auto Upload feature are also presented in Table 2.
table 2. Seven System Agreement using Manual entry for Calibration Compared to Auto
upload (in-Clinic Day 4)*
Measurements
Auto Upload
Manual Entry All
meters
Manual Entry with
Lifescan Ultra
Manual Entry with
Roche Accu-Chek
Manual Entry with
Bayer Ascensia
* Readings less than 81 mg/dL were evaluated by the absolute difference (within 20 mg/dL, 30 mg/dL and
) from the YSI for this analysis.
> 40 mg/dL
110 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
™
YSI Number of
Matched
(mg/dL) Pairs
40-400 mg/dL 720
40-400 mg/dL 849
40-400 mg/dL 275
40-400 mg/dL 291
40-400 mg/dL 283
% of Seven System % of Seven System
Measurements Measurements
within 20 mg/dL within 30 mg/dL
or 20%
67%
69%
78%
69%
62%
% of Seven
System
Measurements
> 40 mg/dL or
or 30%
> 40%
85% 5%
85% 5%
89% 1%
87% 6%
79% 8%