Dexcom G6 Pro User Manual page 116

Participants wore either one or two sensors for up to 10 days. A subset
of participants wore two sensors for the precision study to compare
variability of readings between sensors. Adult participants wore
their G6(s) in the abdomen only; pediatric subjects had the choice
of either abdomen or upper buttocks. Clinic session(s) took place at
the beginning (Day 1, 2), middle (Day 4, 5), and end (Day 7, 10) of the
G6 lifecycle. Depending on the participant's age, they participated in
either 1, 2 or 3 clinic sessions of varying duration.
• Adult subjects: two (2) or three (3) 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
• Pediatric subjects 2-5 years of age: one (1) 4-hour clinic session
(compared to fingerstick blood glucose meter measurements only)
While using the G6 in the clinic, subjects had their blood glucose
measured every 15 minutes with a laboratory reference method,
the Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer.
This instrument is referred to as the "YSI." Readings from the G6
were reported every 5 minutes and paired with YSI values in order to
characterize the accuracy of the G6's glucose reading. No venous
sampling was obtained for 14 pediatric subjects aged 2 to 5 years.
In Study 1, under close observation by the study investigator staff,
the participant's glucose levels were deliberately manipulated per a
protocol to raise or lower glucose to achieve YSI glucose samples
within target glucose bins. Glucose manipulations were done to assess
performance over the range that CGM measures glucose (40–400
mg/dL). In Study 2, participants managed their glucose as they
normally do; glucose was not deliberately manipulated.
The data from these prospective clinical studies were further
processed and analyzed at Dexcom to assess performance of
factory calibration.
G6 Pro User Guide
Appendix G: Technical Information
114