Appendix G: Technical - Dexcom G6 Instructions For Use 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 G6 System • Using Your G6
®
Appendix G: 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%]
81 81