Dexcom G6 - Page 321

Dexcom G6
®
System User Guide
319Appendix F: Technical Information
Table 10. G6 Accuracy to YSI (n=62)
Patient
Population
Number
of
subjects
Total number
of paired
CGM-YSI
Percent within
20/20%
YSI
Day 1
Percent
within
20/20%YSI
MARD
(%)
Overall 62 3,532 93.5 (89.9) 91.1 9.0
Auto-app
(≥18 years)
25 2,145 91.9 (86.6) 91.0 9.8
Auto-app
(6-17 years
old)
37 1,387 95.8 (92.3) 91.3 7.7
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 Number of subjects (n) Percent (95% LB)
Comfort: Painless (mild,
no pain)
76 84%
Ease of use: easy
(somewhat or very)
76 100%
IFU ease of use: easy
(somewhat or very)
61 100%