System Performance In Pediatrics - Dexcom G4 Platinum User Manual

Table 6 is categorized within CGM glucose ranges. For readings less than
or equal to 80 mg/dL (4.4 mmol/L) the absolute difference in mg/dL (mmol/L)
between the two glucose results was calculated. For values greater than 80 mg/
dL (4.4 mmol/L) the absolute percent difference (%) from the SMBG values was
calculated. The percentages of total readings within 20 mg/dL (1.1 mmol/L) or
20%, 30 mg/dL (1.7 mmol/L) or 30% or 40 mg/dL (2.2 mmol/L) or 40% were then
calculated.
Table 7. System Difference to SMBG within CGM Glucose Ranges
CGM Glucose Number of
Ranges mg/dL
(mmol/L) CGM-SMBG
40-400
(2.2-22.2)
40-80
(2.2-4.4)
Overall, the System reads, on average, 14.0% absolute different (Mean Absolute
Percent Difference) than the SMBG values. The Median Absolute Percent
Difference shows that half of the time the System reads about 11.0% or less
different than SMBG values (Table 7).
Adverse Events
No serious adverse events or device-related serious adverse events occurred
during the study. Mild skin irritation, such as erythema or edema, occurred in low
frequency around adhesive area. No infection, bruising, or bleeding occurred at
the sensor needle insertion area or the adhesive area.
11.2.2

SYSTEM PERFORMANCE IN PEDIATRICS

Clinical Study Overview
The System performance was evaluated in a prospective clinical study, 30
participants were enrolled. All participants had Type 1 or Type 2 diabetes
mellitus, and required insulin to manage their diabetes. About 97% of
participants had Type 1 diabetes and about 3% had Type 2 diabetes. The
average age of study subjects was 12 years old, the youngest subject was 2
years of age and the oldest subject was 17 years of age.
Mean Absolute
paired
Difference
7508 14.0%
1699 11.2 mg/dL
(0.62 mmol/L)
Median Absolute
Difference
11.0%
8.0 mg/dL
(0.44 mmol/L)
Dexcom G4 PLATINUM User's Guide | 137