Freestyle Libre 2 Manuel D'utilisation page 68

Table 9a: Overall between Sensor Precision (Adult; n=146) Table 9a: Overall between Sensor Precision (Adult; n=146)
Table 9b: Overall between Sensor Precision (Paediatric; n=137) Table 9b: Overall between Sensor Precision (Paediatric; n=137)
Adverse Events 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) and mild pain were reported around
the insertion site and adhesive area by a small number of subjects (10 out of 146 or 6.8%).
In the Paediatric study, there were 8 instances of erythema (4 "well-defined redness", and 4 "slight
pink"), 5 instances of edema (3 slight edema, 2 instances of slight edema with defined edges), 2
instances of mild bleeding, one instance of mild induration and one instance of mild rash.
Ascorbic Acid Study Ascorbic Acid Study
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
1000 mg ascorbic acid supplement was given with a meal and venous samples were collected every 20
minutes for the next four hours. A maximum average Sensor bias of 0.5 mmol/L was observed around 3
hours after the 1000 mg ascorbic acid dose. Subjects then received a second 1000 mg ascorbic acid
supplement with a meal, and the same process was continued for another 4 hours. A third 1000 mg
ascorbic acid supplement was then given and study subjects were followed for 4 more hours. After the
second dose of ascorbic acid the maximum average Sensor bias increased, with minimal change in
Sensor bias after the third dose, suggesting that saturation had occurred by the second 1000 mg dose
of ascorbic acid. The maximum average Sensor bias after the three 1000 mg doses of ascorbic acid was
less than 1.1 mmol/L.
Bench studies were conducted to test higher levels of ascorbic acid. These studies showed that ascorbic
acid doses greater than 1000 mg every four hours could significantly raise Sensor glucose readings.
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ART41758-100_rev-A 3:14pm 18-JAN-2021