User`s guide

Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 169
presented in Tables 6-A through 6-C.
11
Table 6-A represents the alert
evaluation within 15 minutes of the YSI reading for the pediatric study.
Itisasub-setofthepediatricpopulation—subjectsage6to17years
who had YSI measurements every 15 minutes. Table 6-B represents the
alert evaluation within 15 minutes of the YSI reading for the adult study.
Table 6-C represents the alert evaluation within 30 minutes of an SMBG
reading for 2- to 5-year old subjects in the pediatric study.
Table 6-A. Hyperglycemic Alert and Detection Rate
Evaluation in Reference to YSI 15 Minutes Before and
After (Pediatric Study, Ages 6 to 17 years)
Hyperglycemic
Alert Level
mg/dL (mmol/L)
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection Rate
Hyperglycemia
Missed Detection
Rate
120 (6.7) 91% 9% 98% 2%
140 (7.8) 87% 13% 99% 1%
180 (10.0) 75% 25% 99% 1%
200 (11.1) 71% 29% 98% 2%
220 (12.2) 67% 33% 97% 3%
240 (13.3) 62% 38% 96% 4%
300 (16.7) 43% 57% 93% 7%
11
In the pediatric clinical study, the subject’s glucose levels were not
intentionally manipulated, so there are fewer data samples in the low
and high glucose ranges than in the adult clinical study.