Dexcom G6 User Manual page 320

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 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.
Dexcom G6 ® System User Guide
Appendix F: Technical Information
318