Abbott FreeStyle Libre User manual

Abbott Diabetes Care Ltd.
Range Road
Witney, Oxon
OX29 0YL, UK
User’s Manual
©2017 Abbott ART34745-008 Rev. A 03/17
FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in
various jurisdictions.
Patent: https://www.abbott.com/patents
Distributed by:
Abbott Laboratories
Abbott Place
219 Golf Club Terrace
Constantia Kloof
1709
Johannesburg
South Africa
0800 222 688
[phone]
FLASH GLUCOSE MONITORING SYSTEM
.224”
.257”
4.6”4.6”
ART34745-008_rev-A_cover.indd 1-2 3/28/17 1:19 PM
DO NOT PRINT FROM THIS FILE -
FOR REFERENCE ONLY

Your Name _________________________________________________
.224”
.257”
4.6” 4.6”
ART34745-008_rev-A_cover.indd 3-4 3/28/17 1:19 PM

Contents
Reader Symbols ......................................... 1
Important Safety Information........................... 3
Indications for Use........................................ 3
Contraindications ........................................ 4
Getting to Know Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Reader Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Sensor Kit ...............................................10
FreeStyle Libre Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Setting up Your Reader for the First Time . . . . . . . . . . . . . . 14
Using Your Sensor ......................................17
Applying Your Sensor....................................18
Starting Your Sensor .....................................22
Checking Your Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Adding Notes...........................................29
ART34745-008_rev-A_manual.indd 1 3/28/17 1:37 PM

Reviewing Your History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Logbook . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Daily Graph .............................................34
Other History Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Removing Your Sensor .................................37
Replacing Your Sensor .................................38
Using Reminders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Using the Built-in Meter................................41
Blood Glucose Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Blood Ketone Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Control Solution Testing .................................52
Charging the Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Changing the Reader Settings .........................57
Living With Your FreeStyle Libre System . . . . . . . . . . . . . . . 60
Maintenance and Disposal .............................62
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Reader Does Not Power On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Problems at the Sensor Application Site ..................64
Problems Starting Your Sensor or Receiving
Sensor Readings.........................................65
Blood Glucose or Ketone Error Messages .................68
Problems Checking Your Blood Glucose or Ketone ........72
Perform a Reader Test....................................74
Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
System Specications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Labelling Symbols......................................79
Electromagnetic Compatibility.........................80
Warranty Statement....................................91
ART34745-008_rev-A_manual.indd 2-3 3/28/17 1:37 PM

Reader Symbols
Symbol What It Means
Active Sensor
Direction your glucose is going. See Checking Your
Glucose section for more information
Caution
View previous/next screen
Notes
+
Add more information to notes
Food note
Rapid-acting insulin note
Symbol What It Means
Time changed on Reader
Reminders
Blood glucose or ketone test
Settings
Control solution test result
Low battery
Battery charging
Sensor too cold
Sensor too hot
1 2
ART34745-008_rev-A_manual.indd 1-2 3/28/17 1:37 PM

Important Safety Information
Indications for Use
The FreeStyle Libre Flash Glucose Monitoring System is indicated for
measuring interstitial uid glucose levels in people (age 4 and older) with
diabetes mellitus. The indication for children (age 4 - 17) 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. It 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 reect 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 conrm 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.
Contraindications
The FreeStyle Libre Flash Glucose Monitoring System must be removed
prior to Magnetic Resonance Imaging (MRI).
WARNING:
• The FreeStyle Libre Flash Glucose Monitoring System contains
small parts that may be dangerous if swallowed.
• During times of rapidly changing glucose (more than 0.1 mmol/L
per minute), interstitial uid glucose levels as measured by the
FreeStyle Libre Flash Glucose Monitoring System Sensor may not
accurately reect blood glucose levels. Under these circumstances,
check the Sensor glucose readings by conducting a ngerstick test
using a blood glucose meter.
• In order to conrm hypoglycaemia or impending hypoglycaemia
as reported by the FreeStyle Libre Flash Glucose Monitoring
System Sensor, conduct a ngerstick test using a blood glucose
meter.
• Do not ignore symptoms that may be due to low or high blood
glucose. If you have symptoms that do not match the FreeStyle
Libre Flash Glucose Monitoring System reading or suspect that
your reading may be inaccurate, check the reading by conducting
a ngerstick test using a blood glucose meter. If you are
experiencing symptoms that are not consistent with your glucose
readings, consult your health care professional.
3 4
ART34745-008_rev-A_manual.indd 3-4 3/28/17 1:37 PM

CAUTION:
• On rare occasions, you may get inaccurate Sensor glucose
readings. If you believe your glucose readings are not correct
or are inconsistent with how you feel, perform a blood
glucose test on your nger to conrm your glucose. If the
problem continues, remove the current Sensor and apply a
new one.
• Performance of the System when used with other implanted
medical devices, such as pacemakers, has not been
evaluated.
• The Reader is for use by a single person. It must not be used
on more than one person including other family members
due to the risk of spreading infection. All parts of the Reader
are considered biohazardous and can potentially transmit
infectious diseases, even after performing the cleaning
procedure.
• Some individuals may be sensitive to the adhesive that keeps
the Sensor attached to the skin. If you notice signicant
skin irritation around or under your Sensor, remove the
Sensor and stop using the FreeStyle Libre system. Contact
your health care professional before continuing to use the
FreeStyle Libre system.
System-Related Information
• The FreeStyle Libre Flash Glucose Monitoring System is designed to be
used only with FreeStyle Optium blood glucose and blood ketone test
strips and MediSense control solution.
• Avoid getting dust, dirt, blood, control solution, water or other
substances in the Reader’s USB and test strip ports.
• Physiologic dierences between the interstitial uid and capillary blood
may result in dierences in glucose readings. Dierences in glucose
readings between interstitial uid and capillary blood may be observed
during times of rapid change in blood glucose, such as after eating,
dosing insulin or exercising.
• Severe dehydration and excessive water loss may cause inaccurate
results. If you believe you are suering from dehydration, consult your
health care professional immediately.
• Interfering Substances: Taking ascorbic acid while wearing the Sensor
may falsely raise your Sensor glucose readings. Taking salicylic acid may
slightly lower your Sensor glucose readings. The level of inaccuracy
depends on the amount of the interfering substance active in your
body.
• Store the Sensor Kit between 4°C-25°C. While you don’t need to keep
your Sensor Kit in a refrigerator, you can as long as the refrigerator is
between 4°C-25°C.
5 6
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• If you have a medical appointment that includes strong magnetic
or electromagnetic radiation, for example an X-ray, MRI (Magnetic
Resonance Imaging) or CT (Computed Tomography) scan, remove the
Sensor you are wearing and apply a new one after the appointment.
The eect of these types of procedures on the performance of the
system has not been evaluated.
• The FreeStyle Libre Flash Glucose Monitoring System has not been
evaluated for use in pregnant women, persons on dialysis, or people
less than 4 years of age.
Getting to Know Your System
The FreeStyle Libre Flash Glucose Monitoring System has two main parts: a
handheld Reader and a disposable Sensor, which you wear on your body.
You use the Reader to wirelessly scan the Sensor and get your glucose
readings. The Reader also has a built-in blood glucose and ketone meter,
which works with FreeStyle Optium blood glucose and blood ketone test
strips.
Your System comes in a Reader Kit and a Sensor Kit. When opening your
kits, check that the contents are undamaged and that you have all parts
listed. If any parts are missing or damaged, contact Customer Service.
IMPORTANT: Safety information about the
System is in this User’s Manual. Read all of
the information in the User’s Manual and the
FreeStyle Optium blood glucose and ketone
test strip instructions for use before using your
System.
7 8
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Sensor Kit
The Sensor Kit includes:
• Sensor Pack
• Sensor Applicator
• Product insert
Sensor Pack
Used with the Sensor Applicator to
prepare the Sensor for use.
Sensor Applicator
Applies the Sensor to your body.
The Sensor measures and stores glucose readings when worn on your
body. It initially comes in two parts: one part is in the Sensor Pack and
the other part is in the Sensor Applicator. By following the instructions,
you prepare and apply the Sensor on the back of your
upper arm. The Sensor has a small, exible tip that is
inserted just under the skin. The Sensor can be worn
for up to 14 days.
Reader Kit
The Reader Kit includes:
• FreeStyle Libre Reader
• USB Cable
• Power Adapter
• User’s Manual
• Quick Start Guide
The Reader is used to get glucose readings from your Sensor. It can store
approximately 90-days of glucose history and notes you enter about
activities, such as taking insulin, eating food, or exercising. This information
can help you understand how these activities aect your glucose.
USB Port
Used to charge the Reader
and connect it to a computer.
Test Strip Port
Insert a test strip here to use
the built-in meter.
Touchscreen
Home Button
Turns the Reader on/o
and takes you to the
Home screen from any
other screen.
Sensor
Measures your glucose while on your
body (only visible after applied).
9 10
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The Sensor Glucose Readings screen appears after you use the Reader
to scan your Sensor. Your Reading includes your Current Glucose, a
Glucose Trend Arrow indicating which way your glucose is going, and a
graph of your current and stored glucose readings.
Sensor Glucose Readings
21
15
9
3
14:00 18:00 22:00
4.0
mmol
L
Glucose Going
Low
Rapid-Acting
Insulin Note
Message
Touch for more
information.
Add Notes
Touch to add notes to the
glucose reading.
Food Note
Current Glucose
Glucose from your
latest scan.
Glucose Trend Arrow
Directionyour
glucose is going.
Glucose Graph
Graph of your current
and stored glucose
readings.
The Reader Home Screen provides access to information about your
glucose and the System. You can press the Home Button to get to the
Home Screen.
Home Screen
Ends in 14 days
22:23
Check
Glucose
Review
History
Time
Current time set on
the Reader.
Sensor Status
Information about your
current Sensor.
Battery Level
Battery charge remaining.
Settings
Touch to change the
Reader’s settings.
Review History
Touch to review information
about your past glucose
readings.
Check Glucose
Touch to check your
Sensor glucose.
Reminder
Touch to set or change
reminders.
11 12
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Setting up Your Reader for the First Time
Before using the System for the rst time, the Reader must be set up.
Step Action
1Press the Home Button to turn on the Reader.
2If prompted, use the touchscreen to select your
preferred language for the Reader. Touch OK to
continue.
Note: Use the pad of your nger. Do NOT use
your ngernail or any other object on the screen.
3Set the Current Date using the arrows on the
touchscreen. Touch next to continue.
14
back next
Current Date
June
2016
FreeStyle Libre Software
FreeStyle Libre software can be used to view reports and change Reader
settings. The software is compatible with most Windows and Mac
operating systems. Go to www.FreeStyleLibre.com and follow onscreen
instructions to download and install the software.
INTENDED USE
FreeStyle Libre software is intended for use by individuals and
health care professionals to aid in the review, analysis and
evaluation of information such as Sensor glucose readings,
blood glucose test results, blood ketone test results, and
other data uploaded from the FreeStyle Libre Flash Glucose
Monitoring System, in support of an eective diabetes health
management program.
FreeStyle Libre software is not intended for the diagnosis of
or screening for diabetes mellitus. Users should be aware that
FreeStyle Libre software is merely an information management
tool and it is therefore not intended to substitute for the
support of a health care professional. Individuals should always
consult their health care professional if they have any queries or
concerns about diabetes management.
13 14
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Step Action
6The Reader now displays important information about two key
topics to help you use the system:
• How to understand the Glucose Trend Arrow included on
the Glucose Reading screen.
• How to return to the Home Screen from any other screen.
Touch next to move to the
next topic. At the end of the
Reader setup, touch done to
go to the Home Screen.
Note: Charge the Reader if the battery level is low. Only use the USB cable
and power adapter included with the System.
nextback
When you scan your Sensor
an arrow will indicate your
recent glucose trend:
Rising quickly
Rising
Changing slowly
Falling
Falling quickly
doneback
While using the Reader, press
the Home button to return to
the Home screen.
Step Action
4Set the Current Time. Touch next to continue.
5Set your Target Glucose Range. Work with your
health care professional to determine your Target
Glucose Range. Touch next to continue.
Note: Your Target Glucose Range is displayed
on glucose graphs on the Reader and used to
calculate your Time In Target.
12 00
back next
Current Time
CAUTION: It is very important to set the time
and date correctly. These values aect the
Reader data and settings.
mmol
L
4.4 to 7.8
back next
Target Glucose
Range
?
15 16
ART34745-008_rev-A_manual.indd 15-16 3/28/17 1:37 PM

Applying Your Sensor
Step Action
1Apply Sensors only on the back of your upper
arm. Avoid areas with scars, moles, stretch marks
or lumps.
Select an area of skin that generally stays at
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 dierent site other than the one most
recently used.
2Clean application site with an alcohol wipe and
allow site to dry before proceeding. This helps
the Sensor stay attached to your body.
Note:The area MUST be clean and dry, or the
Sensor may not stick to the site.
Using Your Sensor
CAUTIONS:
• The Sensor Pack and Sensor Applicator are packaged as a
set (separately from the Reader) and have the same Sensor
code. Check that the Sensor codes match
before using your Sensor Pack and Sensor
Applicator. Sensor Packs and Sensor
Applicators with the same Sensor code
should be used together, or your Sensor
glucose readings may be incorrect.
• Intense exercise may cause your Sensor to loosen due to
sweat or movement of the Sensor. If your Sensor comes
loose, you may get no readings or unreliable readings,
which may not match how you feel. Follow the instructions
to select an appropriate application site.
CODE
XXXXXXXXXXX
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YYYY-MM-DD
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17 18
ART34745-008_rev-A_manual.indd 17-18 3/28/17 1:37 PM

Step Action
6The Sensor Applicator is prepared and ready to
apply the Sensor.
7Place the Sensor Applicator over the prepared
site and push down rmly to apply the Sensor to
your body.
CAUTION: The Sensor Applicator now
contains a needle. Do NOT touch inside the
Sensor Applicator or put it back into the
Sensor Pack.
CAUTION: Do NOT push down on the Sensor
Applicator until placed over prepared site to
prevent unintended results or injury.
Step Action
3Open the Sensor Pack by peeling the lid o
completely. Unscrew the cap from the Sensor
Applicator and set the cap aside.
4Line up the dark mark on the Sensor Applicator
with the dark mark on the Sensor Pack. On a
hard surface, press rmly down on the Sensor
Applicator until it comes to a stop.
5Lift the Sensor Applicator out of the Sensor Pack.
Lid
Cap
CAUTION: Do NOT use if the Sensor Pack or
the Sensor Applicator seem to be damaged
or already opened. Do NOT use if past expiry
date.
19 20
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Starting Your Sensor
Step Action
1Press the Home Button to turn on the Reader.
2Touch Start New Sensor.
3Hold the Reader within 4 cm (1.5 inches) of the
Sensor to scan it. This starts your Sensor. If sounds
are turned on, the Reader beeps when the Sensor
has been successfully activated. The Sensor can
be used to check your glucose after 60 minutes.
Note: If the Sensor is not successfully scanned
within 15 seconds, the Reader displays a prompt
to scan the Sensor again. Touch OK to return to
the Home Screen and touch Start New Sensor
to scan your Sensor.
No Active Sensor
22:23
Start New
Sensor
Review
History
minutes
OK
New Sensor
Starting Up
60
Sensor can be used in:
Step Action
8Gently pull the Sensor Applicator away from your
body. The Sensor should now be attached to your
skin.
Note: Applying the Sensor may cause bruising
or bleeding. If there is bleeding that does not
stop, remove the Sensor, and apply a new one at
a dierent site.
9Make sure the Sensor is secure after application.
Put the cap back on the Sensor Applicator.
Discard the used Sensor Pack and Sensor
Applicator according to local regulations.
Sensor
21 22
ART34745-008_rev-A_manual.indd 21-22 3/28/17 1:37 PM

Step Action
3The Reader displays your current glucose reading
along with your glucose graph and an arrow
indicating the direction your glucose is going.
21
15
9
3
mmol
L
Glucose Going
Low
14:00 18:00 22:00
4.0
Checking Your Glucose
Step Action
1Turn the Reader on by pressing
the Home Button, or touch
Check Glucose from the Home
Screen.
2Hold the Reader within 4 cm (1.5 inches) of your
Sensor to scan it. Your Sensor wirelessly sends
glucose readings to the Reader. If sounds are
turned on, the Reader beeps when the Sensor
has been successfully scanned.
Note: If the Sensor is not successfully scanned within 15
seconds, the Reader displays a prompt to scan the Sensor
again. Touch OK to return to the Home Screen and touch
Check Glucose to scan your Sensor.
22:23
Check
Glucose
Review
History
Ends in 14 days
OR
23 24
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The Glucose Trend Arrow gives you an indication of the direction your
glucose is going.
Glucose is rising quickly
(more than 0.1 mmol/L per minute)
Glucose is rising
(between 0.06 mmol/L and 0.1 mmol/L per minute)
Glucose is changing slowly
(less than 0.06 mmol/L per minute)
Glucose is falling
(between 0.06 mmol/L and 0.1 mmol/L per minute)
Glucose is falling quickly
(more than 0.1 mmol/L per minute)
Note: The Glucose Trend Arrow may not always appear with your reading.
Sensor Glucose Readings
Notes:
• The graph displays glucose readings up to 21 mmol/L. Glucose
readings above 21 mmol/L are displayed at 21 mmol/L.
• The symbol may appear, indicating the Reader time was changed.
Gaps in the graph may result or glucose readings may be hidden.
21
15
9
3
14:00 18:00 22:00
Glucose Going
Low
4.0
mmol
L
Glucose Trend Arrow
Current Glucose
Target Glucose Range
25 26
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Display What To Do
21
15
9
3
14:00 18:00 22:00
4.0
mmol
L
Glucose Going
Low
21
15
9
3
14:00 18:00 22:00
13.2
mmol
L
Glucose Going
High
If your glucose is projected to be higher than
13.3 mmol/L or lower than 3.9 mmol/L within 15
minutes, you will see a message on the screen.
You can touch the message button for more
information and set a reminder to check your
glucose.
Note: If you are not sure about a message or reading, contact your
health care professional before you do anything.
The following table shows messages you may see with your glucose
readings.
Display What To Do
21
15
9
3
14:00 18:00 22:00
mmol
L
Low Glucose
LO
21
15
9
3
14:00 18:00 22:00
mmol
L
High Glucose
HI
If LO appears on the Reader, your reading is lower
than 2.2 mmol/L. If HI appears on the Reader, your
reading is higher than 27.8 mmol/L. You can touch
the message button for more information. Check
your blood glucose on your nger with a test strip.
If you get a second LO or HI result, contact your
health care professional immediately.
21
15
9
3
14:00 18:00 22:00
3.5
mmol
L
Low Glucose
21
15
9
3
14:00 18:00 22:00
16.1
mmol
L
High Glucose
If your glucose is higher than 13.3 mmol/L or
lower than 3.9 mmol/L, you will see a message
on the screen. You can touch the message button
for more information and set a reminder to check
your glucose.
27 28
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Step Action
3After you tick the box for food and
insulin notes, the
+
symbol appears
to the right of the Note. You can touch
it to add more specic information to
your note. Then touch OK.
• Insulin notes: Enter the number of
units taken.
• Food notes: Enter grams or
carbohydrate portion information.
Note: Food and rapid-acting insulin notes are shown
on your glucose graphs and in your Logbook as symbols.
4Touch OK to save your Notes.
You can review your Notes from the Logbook. See Reviewing Your History
section for more information.
+
+
+
OK
Add Notes
1 / 4
Rapid-Acting
Insulin
Long-Acting
Insulin
Food
units
Enter Rapid-Acting
Insulin
OK
+
+
+
OK
Add Notes
1 / 4
Rapid-Acting
Insulin
Long-Acting
Insulin
Food
Adding Notes
Notes can be saved with your glucose readings. You can add a note at
the time of your glucose reading or within 15 minutes after your reading
was obtained. You can track food, insulin, exercise and any medication
you take.
Step Action
1From the Glucose Reading screen, add notes
by touching the symbol in the upper right
corner of the touchscreen. If you do not want to
add notes, you can press the Home Button to go
to the Home Screen or hold the Home Button to
turn the Reader o.
2Select the tickbox next to the notes you would
like to add. Touch the down arrow to view other
Note options.
21
15
9
3
14:00 18:00 22:00
Glucose Going
Low
4.0
mmol
L
OK
Add Notes
1 / 4
Rapid-Acting
Insulin
Long-Acting
Insulin
Food
29 30
ART34745-008_rev-A_manual.indd 29-30 3/28/17 1:37 PM

Step Action
3Use the arrows to view the available options.
Logbook
Daily Graph
Average Glucose
Review History
1 / 2
Daily Patterns
Time In Target
Low Glucose Events
Sensor Usage
IMPORTANT: Work with your health care professional
to understand your glucose history.
Reviewing Your History
Reviewing and understanding your glucose history can be an important
tool for improving your glucose control. The Reader stores about 90 days
of information and has several ways to review your past glucose readings,
notes and other information.
Step Action
1Press the Home Button to turn on
the Reader. Press the Home Button
again to go to the Home Screen.
2Touch the Review History icon.
Check Glucose
Scan Sensor to check
glucose.
22:23
Check
Glucose
Review
History
Ends in 14 days
31 32
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