Dexcom SEVEN User Manual page 110

Users and healthcare providers should consider that performance in this study might
be idealized. Participants enrolled in the clinical study, and certain conditions of the
study tend to result in above average glucose control. This, in turn, may result in the
appearance that the Seven System agrees with blood glucose levels better than it does
under typical conditions. Monitors that measure glucose in interstitial fluid often show
better agreement to blood glucose levels when glucose levels are not changing rapidly or
when glucose levels are not extremely low or high. The following are some examples of
why performance of the Seven System may be idealized.
•
The average Hemoglobin A1c among the 72 participants was 7.6%. Many people with
diabetes have higher A1c levels, indicating poorer control of their glucose levels.
•
Subjects took, on average, 6 fingerstick results per day. This enabled subjects to
control their glucose levels better than with fewer fingerstick results per day.
•
While subjects participated in the clinic portion of the study, they were more limited
in their activities than someone at home. They were also provided with all their
meals. Subjects who are more active, or with poor eating habits, may create more
challenging conditions for the Seven System.
•
Blood Glucose meters used in the study were well maintained. Because the meter
is used to calibrate the Seven System, performance may be poorer if the meter
is not well maintained. It is important to carry out quality-control checks on the
meter and code the meter according to the manufacturer's instructions to optimize
performance of the Seven System.
106 | SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
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