Abbott FreeStyle Libre User manual

The FreeStyle Libre Flash Glucose
Monitoring System
NEW STARTER CLINIC - LONDON

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
The FreeStyle Libre flash glucose monitoring
system is indicated for measuring interstitial fluid
glucose levels in people (age 4 and older) with
diabetes mellitus, including pregnant women.
The indication for children (age 4 - 12) is limited to those who are
supervised by a caregiver who is at least 18 years of age. The caregiver
is responsible for managing or assisting the child to manage the
FreeStyle Libre flash glucose monitoring system and also for interpreting
or assisting the child to interpret FreeStyle Libre readings.
The FreeStyle Libre Flash Glucose Monitoring System
Indication of Use

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
The FreeStyle Libre system is designed to replace blood glucose
testing in the self-management of diabetes with the exceptions
listed below. Under the following circumstances, use a blood
glucose meter to check the current glucose readings from the
FreeStyle Libre flash glucose monitoring system sensor:
•During times of rapidly changing glucose levels, interstitial glucose levels as
measured by the sensor and reported as current may not accurately reflect
blood glucose levels. When glucose levels are falling rapidly, glucose readings
from the sensor may be higher than blood glucose levels. Conversely when
glucose levels are rising rapidly, glucose readings from the sensor may be
lower than blood glucose levels.
•In order to confirm hypoglycaemia or impending hypoglycaemia as reported
by the sensor.
•If symptoms do not match the FreeStyle Libre flash glucose monitoring system
reading. Do not ignore symptoms that may be due to low blood glucose or
high blood glucose.
The FreeStyle Libre Flash Glucose Monitoring System
Indication of Use

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
What is Flash Glucose Monitoring?
* A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect
blood glucose levels or if hypoglycaemia or impending hypoglycaemia is reported by the System or when symptoms do not match the System readings. ^ For a
complete glycaemic picture scan sensor every 8 hours.
•Flash glucose monitoring is an easy way to generate the
dense glucose data needed for a complete glycaemic
picture^
•What makes flash glucose monitoring unique is the 1-second
painless scan to collect glucose data. of the reader over the
sensor
•Another key feature of a flash glucose monitoring system is
the small and fully disposable sensor that lasts up to 14
days, requires no user calibration, no routine finger
pricks*, and automatically measures, captures and
stores glucose data^

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
How Glucose is Measured and Stored
The FreeStyle Libre sensor has a thin, sterile filament that is
inserted approximately 5 mm under skin to continuously measure
glucose in the body using interstitial fluid (ISF)
How does the sensor store glucose readings?
The FreeStyle Libre sensor:
•continuously records data for up to 14 days
•records the reading every minute
•stores a glucose reading every 15 minutes for the last 8 hours

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
•The FreeStyle Libre system measures
glucose in the interstitial fluid, or ISF
(the fluid between the body’s cells).
•Glucose in ISF has been shown to be a
reliable indicator of glucose levels in
blood because glucose freely diffuses
from capillaries to the interstitial space.1
•The FreeStyle Libre sensor contains
glucose-sensitive reagents that
measure glucose in the ISF
continuously.
•Glucose diffusion between capillary and
ISF is shown to have a short lag of 5-10
minutes.2
Monitoring Glucose with Interstitial Fluid
1. Rebrin K, Steil GM. Can interstitial glucose assessment replace blood glucose measurements? Diabetes Technology Ther.
2000;2(3):461-472.
2. Rebrin K, Sheppard NF Jr, Steil, GM. Use of subcutaneous interstitial fluid glucose to estimate blood glucose: Revisiting delay and
sensor offset. J Diabetes Sci Technol. 2010;4(5): 1087-1098.

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
The FreeStyle Libre Flash Glucose Monitoring System

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
The FreeStyle Libre Flash Glucose Monitoring System:
A new category and experience in glucose monitoring
The FreeStyle Libre
reader
The FreeStyle
Libre sensor
The LibreView
software*
Simulated data for illustrative purposes only. Not real patient or data. * LibreView is developed, distributed and supported by NewYu, Inc.

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
Sensor pack Sensor Sensor applicator
•1 sensor pack - used with the sensor
applicator and contains the sensor
•1 sensor applicator - applies the
sensor to the back of the upper arm •Alcohol wipes -to clean the application site
•Product insert - provides instructions on
how to apply the sensor
The FreeStyle Libre Sensor Kit

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
The FreeStyle Libre sensor is designed to be easy to apply and easy to wear. It represents technology that is
much less intrusive than traditional BGM and makes glucose testing hassle-free.*
•Water-resistant
Can be worn while bathing, showering,
swimming‡, and exercising
•Applied by the patient
Easy-to-use applicator to apply the sensor
•Automatically captures readings day and night§
With an easy scan, patients can see their glucose
variations, including night-time lows
*In a study conducted by Abbott Diabetes Care, 95.7 % of patients surveyed (n=30) agreed that the FreeStyle Libre system would reduce the hassles of glucose
monitoring.Data on file, Abbott Diabetes Care. †The reader can capture the data from sensor when it is up to 4cm from sensor. ‡Sensor is water-resistant in up to 1 metre of
water. Do not immerse longer than 30 minutes. §For a complete glycaemic picture, scan once every 8 hours.
Sensor Features
•Small size (35 mm x 5 mm) –akin to £2 coin
Discreet—the sensor can scan even through
clothing†
•Designed to stay on the body for up to 14
days
•Requires no finger prick calibration
Eliminates painful finger pricks needed for
calibration