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

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 Reader Kit
•1 FreeStyle Libre reader –compact and lightweight,
easy to hold, with a colour touchscreen
•1 USB cable –can connect to a computer to generate
reports, and used to charge the reader
•1 power adapter –use with the USB cable to charge the
battery, for 3 hours, the battery charge lasts
approximately 7 days, under typical use assumptions*
•User’s manual –all of the information required to
operate the system
•Quick start guide –a guide to get patients started
quickly
*Typical use is assumed to be 10 scans per day

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
Reader Features After the Sensor is Scanned
The reader screen shows:
•Current glucose reading
•Glucose trend arrow indicating if
glucose is going up, down, or
changing slowly, as well as the rate of
this change
•Graph of the last 8 hours of glucose
history
•An optional message with information
about critical glucose levels
•A symbol indicating that food or rapid
acting insulin notes have been added
in the last 8 hours
Glucose Trend
Arrow
Direction and rate
glucose is
heading
Glucose
history
Glucose Reading Screen
Food note
Current
Glucose
reading
The FreeStyle Libre system provides more than just a glucose number
Note:
1. 8 hour graph line will appear flat when readings are below 2.2 mmol/L and above 21.0 mmol/L .
2. 8 hour graph line turns red when readings are below 3.9 mmol/L.
Simulated data for illustrative purposes only. Not real patient or data.

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
Important to Scan the Sensor
Every 1 minute
•Current glucose reading is
updated
•The trend arrow is updated
Every 15 minutes
•8-hour glucose history is
updated
Patients can check their glucose as often as they want. The sensor continuously measures glucose every
minute. It stores this glucose data every 15 minutes.
The sensor stores up to 8 hours
of glucose data.
For example, if a person scans
their sensor at 13:00 and does not
scan until 22:00, the glucose data
from 13:00 to 14:00 is not
captured.
Simulated data for illustrative purposes only. Not real patient or 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 (cont’d)
Data generated following the 1-second scan of the reader over the sensor
1. Current glucose reading:
Based on the most recently updated
glucose value (1 minute)
2. 8-hour history:
The graph is made up of 15-minute
readings stored over the last 8 hours
(15 minute)
3. Trend arrow:
The trend arrow shows the direction
glucose is heading along with rate of
change
Simulated data for illustrative purposes only. Not real patient or data.

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
The glucose trend arrow is a tool to help patients monitor their glucose more closely. It shows the direction a
patient’s glucose is heading—going up, down, or changing slowly.
And, the angle of the arrow indicates how quickly or slowly the patient’s glucose is changing. With this
information, patients can better understand their glucose levels.
Glucose is going up quickly
(more than 0.1 mmol/L per minute)
Glucose Reading Screen
Glucose
Trend
Arrow
Direction
glucose
is
heading
Glucose is going up
(between 0.06 and 0.1 mmol/L per minute)
Glucose is changing slowly
(less than 0.06 mmol/L per minute)
Glucose is going down
(between 0.06 and 0.1 mmol/L per minute)
Glucose is going down quickly
(more than 0.1 mmol/L per minute)
Glucose Trend Arrows
Simulated data for illustrative purposes only. Not real patient or data.

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
Setting Up the FreeStyle Libre Reader

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
How to Set Up the Reader
After the reader is charged, the first step is to set up date and time
2. Use up/down
arrows to set the
current date, touch
next to continue.
1. Press the Home
Button to turn on
the reader.
3. Use the up/down
arrows to set the
current time, touch
next to continue.

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
How to Set Up the Reader (cont’d)
4. Next, use the up/down
arrows to set the
glucose target range.
Touch next to continue.
Patients should work
with their Healthcare
Professional to
determine their target
glucose range.
5. There are 2 screens to
explain the glucose
trend arrows and how to
return to the Home
Screen from any other
screen. Touch “next” to
continue after each
screen.
6. Touch “done” to go to
the Home Screen.

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

ADCMDP180051 –Date of Preparation March 2018
FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions
How to Apply the FreeStyle Libre Sensor
2. Clean the area on the
arm with an alcohol
wipe (included in the
sensor kit) and allow
site to dry.*
Applying the sensor is quick and easy. Patients follow these following steps to apply a new sensor.
3. Open the sensor pack by
peeling the lid off completely.1
1. CAUTION:Do NOT use if the sensor pack or the sensor applicatorseem to be damaged or already opened. Do NOT use if past expiration date. *Avoid areas with scars,
moles, stretch marks, or lumps. Select an area of skin that generally stays flat during your normal daily activities (no bending or folding). Choose a site that is at least 2.5
cm (1 inch) away from an insulin injection site. To prevent discomfort or skin irritation, you should select a different site other than the one most recently used.
1. Apply sensor only on the
back of your upper arm.
Avoid areas with scars,
moles, stretch marks, or
lumps.