Study 2 Overview; Accuracy (Study 2 - Automatic Applicator) - Dexcom G6 Pro User Manual

Study 2 Overview

The purpose of the Study 2 was to assess the performance of the
System with an automatic sensor applicator, which is the final G6
CGM System configuration. The automatic applicator was designed to
provide more consistent sensor insertions.
The study was a prospective, multi-center, single-arm study
that enrolled 76 subjects at four (4) US clinical sites. No glucose
manipulations were performed in this sub-study. Subjects participated
in assigned clinic sessions (Day 1, 2, 4-5, 7 and/or 10):
• Adult subjects: two (2) 12-hour clinic sessions
• Pediatric subjects 13-17 years of age: one (1) 12-hour clinic session
• Pediatric subjects 6-12 years of age: one (1) 6-hour clinic session.
The data from Study 2 was also further processed at Dexcom to assess
performance of factory calibration.

Accuracy (Study 2 - Automatic Applicator)

Accuracy of the G6 is characterized by assessing its readings against
blood glucose values from YSI. Accuracy of the G6 was assessed
with paired G6 Pro readings to YSI blood glucose values. For glucose
value less than or equal to 70 mg/dL, the absolute difference in mg/
dL between the two glucose results was calculated. For glucose value
greater than 70 mg/dL, the absolute difference (%) relative to the YSI
values was calculated. The percentages of total readings within 20 mg/
dL or 20% over the System lifecycle and on Day 1 are provided in Table
10. The results are also presented for pediatrics and adults separately.
For example, the total number of data pairs considered in the analysis
was 3,532. Of these, 92% of the System readings fall within ± 20 mg/
dL of the YSI blood glucose values < 70 mg/dL and within ± 20% of
YSI blood glucose values ≥ 70 mg/dL for adults and 96% readings fall
within 20/20% for pediatrics.
G6 Pro User Guide
Appendix G: Technical Information
143