Dexcom G4 Guide de l'utilisateur télécharger pdf (Page 154)

152 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System

and required insulin or oral medication to manage their diabetes. In

the Original Study, 83% of subjects had Type 1 diabetes, and 17%

of subjects had Type 2 diabetes. In the Software 505 Study, 86% of

subjects had Type 1 diabetes, and 14% of subjects had Type 2 diabetes.

Both studies included subjects greater than 18 years of age.

Subjects in both studies used the System for seven days. In the

Original Study, thirty-six subjects each wore 2 sensors; in the Software

505 Study, all subjects wore 1 sensor only. Throughout the 7-day wear

period,thesensorwascalibratedwithanaverageof2ngersticksper

day (approximately once every 12 hours). In the Original Study, subjects

used the LifeScan

OneTouch

Ultra

2 meter and in the Software 505

Study, subjects used Bayer’s CONTOUR

NEXT USB meter.

In the Original Study, all subjects were evaluated in a controlled clinic

environment on all three clinic days: Day 1, Day 4, and Day 7 of the

7-day wear period. In the Software 505 Study, subjects were evaluated

in one of the three clinic days so there are fewer data samples than

in the Original Study. While using the System in the clinic, subjects

had their blood glucose measured every 15 minutes with a reliable

laboratory method, the Yellow Springs Instrument 2300 STAT Plus

™

Glucose Analyzer. This instrument is referred to as the “YSI.” Readings

from the System were reported every 5 minutes and paired with YSI

values in order to characterize how well the System readings agreed

with laboratory standard blood glucose results. The remainder of the

study took place at home, and the System performance was also paired

with the comparative meter results, referred to as the “SMBG.”

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Dexcom G4 Guide de l'utilisateur Page 154