User's Guide

Dexcom G6 System User Guide
45
Chapter 4: What is the G6?
Acetaminophen Blocking
In previous generations of Dexcom CGM systems (G4/G5), acetaminophen could affect
your sensor readings, making them look higher than they really were. However, with
the G6, you can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg)
every 6 hours and still use the G6 readings to make treatment decisions. Taking higher
than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may
affect the G6 readings and make them look higher than they really are.
Additional notes for health care professionals:
A clinical study was conducted to demonstrate that a maximum dose of acetaminophen
(1000 mg) does not interfere with the G6 readings. 65 adult subjects wore both a
G6 and a G4 PLATINUM with SW505 CGM system. The G4/G5 sensor was used as a
comparator for establishing the time to reach a peak acetaminophen concentration (~1
hour), in the interstitial fluid, from the time the acetaminophen was administered. The
observed peak plasma acetaminophen concentration ranged from 0.2 to 2.6 mg/dL.
To assess whether this peak acetaminophen concentration had an interference effect
on the G6 readings, the G6 readings were compared to reference plasma glucose
measurements with YSI. Venous blood was sampled every 10-15 minutes from 1 hour
before and up to 6 hours after the acetaminophen was administered. The observed
mean maximum bias of the G6 readings to the reference YSI measurements at the time
of peak acetaminophen concentration across all subjects was +5.2 mg/dL and was
statistically significantly lower than the performance goal of <10 mg/dL (one-sided
upper 95% CI of 6.4 mg/dL, p < 0.001).
While no interference effect was observed in the clinical study with a maximum
dose, bench studies were conducted to test higher concentrations of acetaminophen.
According to the bench testing, acetaminophen concentrations of > 6.5 mg/dL
(~2-3 times maximum therapeutic levels) showed significant bias. Supratherapeutic
(high levels of acetaminophen beyond the maximum dose) levels may cause an
overestimation of G6 readings.
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