Dexcom G4 Guide de l'utilisateur télécharger pdf (Page 159)

Dexcom G4 PLATINUM User’s Guide | 157

System does not display glucose values below 40 mg/dL or above

400 mg/dL, the comparisons to the actual blood glucose levels (as

determinedbytheYSIanalyzer)whenCGMisclassiedas“LOW”

or “HIGH” are included separately in Table 2. The table includes the

numbers and the cumulative percentages when YSI values were less

than certain glucose levels (for “LOW”), and when YSI values were

greater than certain glucose levels (for “HIGH”).

Original Study (SW10050): When the System displayed “LOW” (155

occasions), 92% (142 out of 155) of the YSI values were less than 80

mg/dL, and only 79% (123 out of 155) of the YSI values were less than

70 mg/dL. When the System displayed “HIGH” (248 occasions), 99%

(246 out of 248) of the YSI values were greater than 240 mg/dL, and

96% (238 out of 248) of the YSI values were greater than 280 mg/dL.

Software 505 Study (SW10505): When the System displayed “LOW”

(18 occasions), 100% (18 out of 18) of the YSI values were less than

80 mg/dL, and 94% (17 out of 18) of the YSI values were less than 70

mg/dL. When the System displayed “HIGH” (45 occasions), 100% (45

out of 45) of the YSI values were greater than 240 mg/dL, and 100% (45

out of 45) of the YSI values were greater than 280 mg/dL.

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Dexcom G4 Guide de l'utilisateur Page 159