Device Performance Characteristics; System Accuracy; Product Specifications; Chapter 15 - Technical Information - Dexcom G5 mobile User Manual

Chapter 15
Everything Else G5:
Technical Information

15.1 Device Performance Characteristics

System Accuracy

The CGM System accuracy is evaluated through clinical studies1 that compare CGM glucose values
to reference glucose values. The accuracy is based on the percentage of CGM glucose readings that
are within(±) 20%, 30% or 40% at glucose values above (>) 80 mg/dL (4.4 mmol/L), or within 20 mg/
dL (1.1 mmol/l), 30 mg/dL (1.7 mmol/L) or 40 mg/dL (2.2 mmol/L) at glucose values at or below(≤) 80
mg/dL (4.4 mmol/L) of the reference glucose values. The Yellow Springs Instrument 2300 STAT Plus
Glucose Analyzer (YSI) were used as the reference glucose values in these studies.
Table 1. Percentage of CGM Glucose Readings within %20/20, %30/30, or
%40/40 of the YSI.
Study
Adults
(18 years and
above)
Pediatrics
(Ages 2-17 years
old)
For more information on the clinical study results, see website at: dexcom.com/global
1

15.2 Product Specifications

The Dexcom G5 Mobile CGM System is intended for use by patients at home and in
healthcare facilities.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer
of this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Dexcom G5 Mobile System User Guide
Technical Information
Number of
Matched Pairs
CGM-YSI
2263
2262
%20/20
(%20/1.1) (%30/1.7)
93%
91%
%40/40
%30/30
(%40/2.2)
98%
96%
™
99%
98%
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