Performance Characteristics - Freestyle LibreLink Manuel D'utilisation

ART41361-001_rev-A 2:18 pm 30 aug 2019
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

Performance Characteristics

Note: Please consult your health care team on how to use the information in this section. Refer to the
Quick Reference Guide for a plain language summary of key performance measures.
Clinical Study Overview
Performance of the FreeStyle Libre Flash Glucose Monitoring System (the System) was evaluated in a
clinical study.
The study was conducted at 4 centres with a total of 95 subjects with diabetes (84.2% Type 1, 15.8% Type
2). All subjects were aged eighteen and older. Subjects in the study required insulin to manage their
diabetes. Each subject wore up to two FreeStyle Libre Sensors on the back of the upper arm. During the
study, subjects tested their blood glucose using fingerstick capillary samples at least eight times during
each day of the study. Subjects used the blood glucose meter built into the FreeStyle Libre Reader.
Additionally, subjects had their venous blood glucose analysed up to 112 times over four separate visits to
the clinical centre. Venous blood was analysed using the Yellow Springs Instrument Life Sciences 2300
STAT Plus™ Glucose & Lactate Analyzer (YSI). YSI is a laboratory glucose and lactate analyser of whole
blood and plasma and is a widely recognised standard in laboratory analysis of blood glucose. Glucose
readings obtained from the System were compared to glucose readings obtained from the YSI to evaluate
the performance of the System. Three lots of Sensors were evaluated in the study.
Agreement with YSI Levels
Agreement between FreeStyle Libre Glucose Measurement (GM) and venous blood was characterised by
using paired GM and Yellow Springs Instrument measurements (YSI). The accuracy of GM versus YSI
reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30%
and 40% for reference values 4.44 mmol/L and above, and 0.83 mmol/L, 1.11 mmol/L, 1.67 mmol/L and
2.22 mmol/L for values below 4.44 mmol/L when glucose levels are assigned using the YSI values. Overall,
90.3% of results were within ±1.11 mmol/L / 20% of YSI reference.
Agreement with GM Glucose Levels
Agreement between GM and venous blood was characterised by using paired GM and Yellow Springs