Adverse Events
No device related serious adverse events occurred during the studies. In the Adult study, mild skin
irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion
site and adhesive area by a small number of subjects (10 out of 146 or 6.8%). Pain was mostly
reported as none with only one instance of mild pain. In the Pediatric study, there were 8 instances
of erythema (4 “well-defined redness”, and 4 “slight pink”), 5 instances of edema (3 slight edema, 2
slight edema with defined edges), 2 instances of mild bleeding, one instance of mild induration and
one instance of mild rash.
Ascorbic Acid Interference
Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor
glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings
which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements
including multivitamins. Some supplements, including cold remedies such as Airborne® and
Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be taken while
using the Sensor. See your health care professional to understand how long ascorbic acid is active in
your body.
Additional notes for Health Care Professionals
A clinical study was conducted to evaluate the effect of ascorbic acid on Sensor performance. Data
from 57 adult subjects with diabetes was collected over a 13-hour period. Each subject had a one-
hour baseline phase where venous blood was collected every 10 minutes. After this first hour, a dose
of 1000 mg ascorbic acid was given with a meal and venous samples were collected every 20 minutes
for the next four hours. A maximum average sensor bias of 9.3 mg/dL was observed around 3 hours
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