Dexcom G7 - Page 133

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Adult subjects: three approximately 12-hour clinic sessions
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Pediatric subjects 13-17 years of age: two approximately 12-hour clinic sessions
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Pediatric subjects 7-12 years of age: one approximately 6-hour clinic session
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Pediatric subjects 2-6 years of age: one approximately 4-hour clinic session
(compared to fingerstick blood glucose meter measurements only).
While using G7 in the clinic, subjects had their blood glucose measured every 10-15
minutes with a comparator method, the Yellow Springs Instrument 2300 STAT Plus™
Glucose Analyzer. This instrument is referred to as the YSI. Readings from G7 were
reported every 5 minutes and paired with YSI values to characterize the accuracy of
the sensor reading. No venous sampling was obtained for pediatric subjects aged 2 to
6 years.
Under close observation by the study investigator staff, the glucose levels were
deliberately manipulated per the protocol to raise or lower glucose to achieve YSI
glucose samples within target glucose bins for participants aged 13 and older unless
they were on non-intensive insulin therapy. Glucose manipulations were done to
assess performance over the range G7 measures glucose (40-400 mg/dL).
No display devices were used in Study 1; a validated process was used to generate
the data from the data-logging transmitters. The subjects and study staff were unable
to view or utilize G7 data during this study.
Accuracy
G7 accuracy was assessed with paired sensor readings to YSI blood glucose values.
For blood glucose values less than 70 mg/dL, the absolute difference in mg/dL
between the two glucose results was calculated. For values greater than or equal to
70 mg/dL, the absolute difference (%) relative to the YSI values was calculated. In
addition, the mean absolute relative difference (MARD) shows the average amount the
sensor readings differ from the YSI glucose. The percentages of total readings within
20 mg/dL or 20% (20/20%) are provided in Tables 1-A. The tables are further
categorized within CGM glucose ranges, within age groups (Tables 1-B and 1-C) and
categorized within YSI glucose ranges (Tables 1-D and 1-E). When you see a sensor
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