User`s guide

166 | Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
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the System reading that occurred immediately after the YSI reading was
collected. There were 9555 paired System and YSI results evaluated.
We suggest that you ask your doctor what alert settings would be best
for you.
The Low Glucose Alert
Estimates of how well the adjustable Low Glucose Alert performs are
presented in Tables 5-A through 5-C.
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Table 5-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 5-B represents the
alert evaluation within 15 minutes of the YSI reading for the adult study.
Table 5-C represents the alert evaluation within 30 minutes of an SMBG
reading for 2- to 5-year old subjects in the pediatric study.
Table 5-A. Hypoglycemic Alert and Detection Rate
Evaluation in Reference to YSI 15 Minutes Before and
After (Pediatric Study, Ages 6-17)
Hypoglycemic
Alert Level
mg/dL (mmol/L)
True
Alert
Rate
False
Alert
Rate
Hypoglycemia
Detection Rate
Hypoglycemia
Missed Detection
Rate
55 (3.1) 0% 100% 0% 100%
60 (3.3) 11% 89% 25% 75%
70 (3.9) 47% 53% 50% 50%
80 (4.4) 55% 45% 55% 45%
90 (5.0) 69% 31% 62% 38%
100 (5.6) 75% 25% 62% 38%
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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.