Performance Characteristics
Note: Please consult your healthcare team on how to use the information in this
section.
Performance Characteristics
Performance of the Sensor was evaluated in a controlled clinical study. The study
was conducted in 4 centres and a total of 100 subjects ages 4 years and older with
diabetes were included in the e"ectiveness analysis. Each subject wore up to two
Sensors for up to 14 days on the back of the upper arm. During the study, subjects
had their venous blood glucose analysed over up to three separate visits to the
clinical centre using the Yellow Springs Instrument Life Sciences 2300 STAT Plus™.
Three lots of Sensors were evaluated in the study.
Fig 1. Comparison of the Sensors vs. YSI reference.
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