Dexcom G6 User Manual page 321

Table 10. G6 Accuracy to YSI (n=62)
Patient
Population
Overall
Auto-app
(≥18 years)
Auto-app
(6-17 years
old)
Patient Comfort (Study 2 - Automatic Applicator)
Enrolled patients were asked to complete questionnaires on comfort and ease of use of
the G6 with automatic applicator. The questionnaires were completed by the subjects
or their parents/guardians. Subjects were asked to focus on ease or difficulty with their
initial experience of sensor insertion and transmitter attachment.
Eighty-four percent (84%) of subjects felt the automatic sensor applicator was painless.
All reported subjects (100%) found that the automatic applicator was easy to use and
the IFU was easy to understand.
Table 11. Survey on Automated Applicator (n=76)
Question
Comfort: Painless (mild,
no pain)
Ease of use: easy
(somewhat or very)
IFU ease of use: easy
(somewhat or very)
Dexcom G6 ® System User Guide
Appendix F: Technical Information
Number Total number
of of paired
subjects CGM-YSI
62 3,532
25 2,145
37 1,387
Number of subjects (n)
Percent within
20/20%
YSI
93.5 (89.9)
91.9 (86.6)
95.8 (92.3)
76
76
61
Day 1
Percent MARD
within (%)
20/20%YSI
91.1 9.0
91.0 9.8
91.3 7.7
Percent (95% LB)
84%
100%
100%
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