Appendix G Technical Information; Device Performance Characteristics; Summary - Dexcom one User Manual

Appendix G
Technical information
G.1 Device performance
characteristics summary
When LOWER is better
Adults
9.8%
Day 1:
8.6%
Day 2:
8.7%
Days
4–5:
10.7%
Day 7:
10.6%
Day 10:
10.6%
When HIGHER is better
Adults
92%
[100%]
Reference is YSI (Yellow Springs Laboratory
*
Instrument)
Dexcom ONE User Guide
Technical information
Performance metrics*
Overall Accuracy
Mean ARD% (MARD),
2.22–22.22 mmol/L
(% average absolute
error versus reference
across all glucose
levels)
Accuracy Over Time
Mean ARD% (MARD),
2.22–22.22 mmol/L
Performance metrics*
Clinical Accuracy
% of readings that
were in the Clarke
Error Grid (CEG) A
Zone
[% CEG A+B Zone]
Pediatrics
7.7%
Day 1:
10.5%
Day 2:
7.8%
Days 4–5:
7.2%
Day 7:
6.2%
Day 10:
7.1%
Pediatrics
96%
[99.8%]
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