Abbott FreeStyle Libre 14 Day System Instruction Manual
- June 17, 2024
- Abbott
Table of Contents
Abbott FreeStyle Libre 14 Day System
Product Information
Specifications
- Product Name: FreeStyle Libre 14-day system
- Continuous Glucose Monitoring (CGM) solution
- Accurate sensor for insulin dosing
- Convenient size: approximately the size of 2 stacked quarters
- Sensor worn on the back of the upper arm
- Handheld reader included
- Compatible with the FreeStyle LibreLink app for real-time glucose readings on a smartphone
Product Usage Instructions
Getting Started
To start using the FreeStyle Libre 14-day system, follow these steps:
- Ensure you have all the contents mentioned in the package.
- Attach the sensor to the back of your upper arm as instructed in the user manual.
- Turn on the handheld reader.
- Swipe the reader over the sensor to scan it.
- Wait for the reader to display the glucose readings.
Using the FreeStyle LibreLink App
If you prefer to view real-time glucose readings on your smartphone, you can
download and use the FreeStyle LibreLink app. Follow these steps:
- Download and install the FreeStyle LibreLink app from your smartphone’s app store.
- Open the app and follow the on-screen instructions to set it up.
- Ensure your sensor is attached to the back of your upper arm.
- Open the app and scan the sensor using your smartphone’s camera.
- Wait for the app to display the glucose readings.
Fingerstick Requirements
While the FreeStyle Libre 14-day system provides continuous glucose
monitoring, there are certain situations where fingersticks are still required
for treatment decisions. These situations include:
- When you see the Check Blood Glucose symbol
- When symptoms do not match system readings
- When you suspect readings may be inaccurate
- When you experience symptoms that may be due to high or low blood glucose
Frequently Asked Questions (FAQ)
-
Q: Can I wear the sensor on any part of my body?
A: No, the sensor should be worn on the back of the upper arm as instructed in the user manual. Wearing it on other parts of the body may affect accuracy. -
Q: How often do I need to replace the sensor?
A: The sensor should be replaced every 14 days to ensure accurate readings. -
Q: Can I swim or shower with the sensor?
A: Yes, the sensor is water-resistant and can be worn during swimming or showering. However, prolonged exposure to water may affect its performance. -
Q: Can I use the FreeStyle LibreLink app without the handheld reader?
A: Yes, the FreeStyle LibreLink app can be used independently without the handheld reader. It allows you to scan the sensor directly using your smartphone’s camera.
*Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
Welcome to your new FreeStyle Libre 14-day system
Inside, you’ll find everything you need to start managing your diabetes with
the accurate,1 convenient, and user-friendly continuous glucose monitoring
(CGM) solution.
What Is CGM
Continuous glucose monitoring (CGM)
CGM automatically tracks your glucose levels day and night. These systems
generally consist of a:
- Sensor, which is worn on the body for a specified period to measure and store glucose levels at regular time intervals
- Monitor, which allows you to view your glucose levels at any time. Some CGM systems also allow access to glucose levels on your compatible smartphone
What can CGM do for you?
CGM systems can detect trends and patterns for you and your doctor, which
can help inform decisions on:
With actionable insights and a more complete picture of your glucose levels, CGM can help you better manage your diabetes.
Comparing CGM to traditional blood glucose monitoring (BGM)
CGM goes beyond current readings with additional insights based on where
your glucose has been, and where your glucose is going.
Continuously tracked for a more complete view
Because blood glucose meters only provide you with a measurement at a
single moment in time, highs and lows can go undetected—even with multiple
daily fingersticks. As you can see in the chart below, each of the blood
glucose readings appear to be in range, while in reality, several highs and
lows were missed throughout the day.
NOTE: See page 30 for more information about why glucose readings may be different between CGM and BGM.
Discover
FreeStyle Libre 14-day system
-
Accurate1
Sensor automatically measures glucose readings day and night,* and is accurate for insulin dosing† -
Convenient
The small sensor is about the size of 2 stacked quarters and can be scanned discreetly,1 even through clothing -
User-friendly
Sensor is painless1 to apply and easy to wear.1 The sensor is water-resistant so you can swim,§ shower, or exercise
Freedom from fi ngersticks†
The FreeStyle Libre 14-day system is a continuous glucose monitoring
solution that includes a handheld reader and a sensor worn on the back of the
upper arm. You can also download the FreeStyle LibreLink app, which allows you
to scan your sensor and get real-time glucose readings on your compatible
smartphone.
Instead of fingersticks,† simply swipe the reader over the sensor to view:
- A current glucose reading
- A glucose trend arrow
- An 8-hour history of your glucose levels
Based on the sensor being replaced once every 14 days, and scanned at least
once every 8 hours.
Fingersticks are required for treatment decisions when you see Check Blood
Glucose symbol, when symptoms do not match system readings, when you suspect
readings may be inaccurate, or when you experience symptoms that may be due to
high or low blood glucose.
The reader can capture data from the sensor when it is within 1 cm to 4 cm of
the sensor.
Sensor is water-resistant in up to 1 meter (3 feet) of water. Do not immerse
longer than 30 minutes.
The FreeStyle LibreLink app is compatible with iPhone 7 and later running iOS
11 and later.
System Overview
- Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
- The FreeStyle LibreLink app and FreeStyle Libre 14-day readers have similar but not identical features. Fingersticks are required for treatment decisions when you see the Check Blood Glucose symbol when symptoms do not match system readings when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
- If you want to use your reader, you must start the sensor with the reader first. Remember that FreeStyle LibreLink and FreeStyle Libre 14-day readers do not share data. For complete information on a device, be sure to scan your sensor every 8 hours with that device; otherwise, your reports will not include all your data.
- The FreeStyle LibreLink app is compatible with iPhone 7 and later running iOS 11 and later.
- LibreView is developed, distributed, and supported by NewYu, Inc. The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice. Trademarks are the property of their respective owners. Images are for illustration purposes only. Not actual patient data.
Getting Started
How to assemble and apply your FreeStyle Libre 14-day sensor:
-
Site selection
- Select an area on the back of the upper arm that generally stays flat during normal daily activities.
- Keep the adhesion site smooth and, if necessary, clean-shaven.
NOTE: Applying to an unapproved location may result in inaccurate glucose readings. Avoid scars, moles, stretch marks, lumps and insulin injection sites. Rotate sites between applications to avoid skin irritation.
-
Site preparation
- Clean your skin with mild, non-moisturizing soap and water to remove any residue from your skin.
- Clean your skin using an alcohol wipe.
- Allow skin to dry completely (without blowing on it) before attaching new sensor.
NOTE: See page 15 for additional products that may help with sensor adhesion or removal.
-
Sensor preparation
- Peel lid from Sensor Pack and unscrew cap from Sensor Applicator.
- Line up marks on Sensor Applicator and Pack. Press down firmly on Sensor Applicator until it comes to a stop.
- Lift Sensor Applicator out of Sensor Pack. Sensor Applicator is now ready to apply the sensor.
CAUTION: Sensor Applicator will now contain a needle. Do not touch inside Sensor Applicator or place back inside Sensor Pack.
NOTE: Sensor Pack and Sensor Applicator codes must match or glucose readings may be inaccurate.
-
Sensor application
- Place the Sensor Applicator over the application site and press firmly to apply.
- Gently pull the Sensor Applicator away from your body.
- Make sure the sensor is secure by pressing the sensor down and running your finger along the sensor adhesive.
-
Sensor activation
- Turn on the FreeStyle Libre 14-day reader or FreeStyle LibreLink app.
- Tap the ‘Start New Sensor’ icon.
- Scan the sensor with the reader or your compatible smartphone* to begin the 1-hour warm-up period.
NOTE: If a sensor is first activated with the FreeStyle LibreLink app, real-time readings will ONLY be available on your compatible smartphone.*
To pair your sensor with both the reader AND app:
-
* Start your sensor with the FreeStyle Libre 14-day reader first.- At any time after you start your sensor with the reader, scan the sensor with the FreeStyle LibreLink app.
Sensor adhesion and removal
You may find it helpful to use additional products when applying and
removing your sensor. Some third-party options are listed here, but everyone’s
skin is different. Try a variety of products to find the right combination for
you.
Products that help with sensor adhesion
Products that help with sensor removal
NOTE: To remove the sensor, pull up the adhesive edge that keeps the sensor attached to your skin, then slowly peel from the skin in a single motion.
Real-time readings
The Sensor Glucose Readings screen appears after you scan the sensor with your
reader or compatible smartphone.* Whether you scan your sensor with the
FreeStyle Libre 14-day reader or the FreeStyle LibreLink app, each reading
will include:
- Current glucose reading.
- Glucose trend arrow, indicating which way your glucose is headed.
- A graph showing 8 hours of your glucose history.
You can also add meal (ie, carb count), exercise, and insulin dosing notes directly on the reader and app after each scan.
Remember to scan your FreeStyle Libre 14-day sensor at least once every 8 hours to avoid gaps in your daily graph. The FreeStyle Libre 14-day sensor holds 8 hours of data, so it’s important to scan at least that often to maintain a complete picture of your glucose measurements.
Glucose Insights
Empowering you with a more complete view of your diabetes
FreeStyle Libre 14 day system measures glucose every minute, and stores
readings every 15 minutes for up to 90 days,* providing you and your doctor
with actionable insights. The more you check your readings, the better you’ll
understand how the system works, and how those insights can impact the
decisions you and your doctor make as you work together to build a plan for
managing your diabetes.
Reading your reports
Access a variety of reports on both your FreeStyle Libre 14-day reader and
compatible smartphone.*
Daily graph
Shows your Target Glucose Range and symbols for food or rapid-acting insulin
notes you have entered.
Remember, if your sensor is not scanned at least once every 8 hours, there
will be a gap in your daily graph like the one shown here. To ensure you have
a complete picture of your glucose data, be sure to scan your sensor often
.
Sharing your reports
LibreView allows you to share glucose data with your healthcare providers
If you are uploading your reader data at home or using the FreeStyle LibreLink app, your doctor may ask you to share your glucose data with them to guide you through managing your diabetes. There are 2 ways to connect your LibreView account to your healthcare provider’s LibreView account. First, create an account on www.LibreView.com, then follow the steps below:
Option 1: Accept the invitation from your healthcare provider
- You will receive an email invitation to join your provider’s practice.
- Open the email and click ‘Accept’.
- Sign in to your LibreView account and click ‘Accept’.
Option 2: Connect manually with your healthcare provider’s ID
- Your doctor will provide you with a ‘Practice ID’.
- Log in to www.LibreView.com and navigate to ‘Account Settings’ from the right navigation menu.
- From the ‘Account Settings’ page, click on the ‘My Practices’ tab.
- Input the ‘Practice ID’ and click ‘Add’.
You are now ready to begin sharing your detailed glucose reports.
Additional Information
Helping you get the most out of your new FreeStyle Libre 14-day system:
Designed to fit into your daily life
-
Showering, bathing, and swimming
Your sensor is water resistant and will continue working as long as it is not submerged more than 3 feet or kept under water longer than 30 minutes at a time. -
Exercising
Maintain your active lifestyle with FreeStyle Libre’s 14-day system. Use skin adhesive* before applying the sensor if sweating causes your sensor to loosen. -
Getting dressed
The sensor is discreet,1 hardly noticeable,1 and can be scanned through your clothing. -
Traveling
You can safely use your system at all times while on an aircraft; however, do not expose the sensor to airport full-body scanners. Request another type of screening to avoid removing your sensor. -
Medical procedures
Notify your healthcare provider and remove your sensor when necessary. Exposing the sensor to MRI, CT scan, diathermy, or X-ray may cause damage and incorrect readings.
Abbott Diabetes Care is not responsible for the adverse effects of skin
adhesives. Everyone’s skin is different; you may need to try various products
to find the one that is right for you. Please refer to the FreeStyle Adhesion
Guide for more information.
The reader can capture data from the sensor when it is within 1 cm to 4 cm of
the sensor.
Understanding trend arrows
- Tools that can impact treatment decisions
Trend arrows can help you interpret your glucose levels more easily. Unlike BGM, which provides only a current reading, trend arrows show both the direction and speed at which your glucose levels are changing. Combined with your current reading, trend arrows give you a more complete picture so you can make more informed treatment decisions.
Important notes
Avoid insulin “stacking” to help reduce low blood sugar. CGM systems can
replace blood glucose testing except in a few situations. If any of the
following apply, perform a blood glucose check before making any treatment
decisions:
- Anytime you see the Check Blood Glucose symbol
- If you think your glucose readings are not correct
- If your glucose readings do not match how you feel
Interpreting trend arrows
A Day in the Life
Why are glucose readings different?
Rather than taking glucose readings from your blood, CGM sensor readings are
taken from interstitial fluid, a thin layer of fluid that surrounds the tissue
cells below your skin. As carbohydrates are digested, glucose enters your
bloodstream before it is absorbed into the interstitial fluid. Think of
glucose readings as the cars of a train, where the front of the train is blood
glucose and the back of the train is sensor glucose.
Understanding the lag1
Because glucose enters the bloodstream first, blood glucose readings lead to
sensor glucose readings. Eventually, sensor glucose readings catch up to blood
glucose readings just like the back of a train following the front of a train.
Instead of focusing only on a single moment in time, CGM gives you a more
complete picture of where your glucose is going, and where your glucose has
been, so you can make more informed treatment decisions.
- When the train is traveling on a flat track, where there is little fluctuation between glucose levels, blood glucose and sensor glucose are similar.
- When glucose levels are changing rapidly, blood glucose may not be the same as sensor glucose.
- This difference is known as the lag, and will be more evident after meals, insulin, and activity.
Maximizing the value of each visit
Getting the most out of your doctor’s appointments
-
Enter notes on your reader
Add notes after each scan to help your doctor identify how medication, activity, or nutrition affects your glucose levels. -
Add comments to each note
On the FreeStyle LibreLink App (feature not available on the reader), enter any questions you may have on your last reading. These questions can guide the conversation with your doctor and inform treatment decisions. -
Scan sensor at least every 8 hours
Your sensor stores the last 8 hours of glucose data. The more you scan, the more complete picture your doctor has to help you better manage your diabetes.
Support
Questions? We’re here for you.
We want to make sure you are always satisfied with your FreeStyle Libre 14-day
system. If you ever have any issues or concerns, please contact our Customer
Service Team or visit our website for more information and interactive
resources.
1-855-632-8658
8 AM-8 PM ET, Monday-Friday (excluding holidays)
FreeStyleLibre.us
*Fingersticks are required for treatment decisions when you see the Check Blood Glucose symbol when symptoms do not match system readings when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.
Indications and Important Safety Information
FreeStyle Libre 14-day Flash Glucose Monitoring system is a continuous glucose
monitoring (CGM) device indicated for replacing blood glucose testing and
detecting trends and tracking patterns aiding in the detection of episodes of
hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy
adjustments in persons (age 18 and older) with diabetes. The system is
intended for single-patient use and requires a prescription.
CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or
high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor
glucose readings with a blood glucose meter when the blood Glucose symbol
appears, when symptoms do not match system readings, or when readings are
suspected to be inaccurate. The system does not have alarms unless the sensor
is scanned, and the system contains small parts that may be dangerous if
swallowed. The system is not approved for pregnant women, persons on dialysis,
or critically-ill populations. Sensor placement is not approved for sites
other than the back of the arm and standard precautions for transmission of
blood-borne pathogens should be taken. The built-in blood glucose meter is not
for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar
state, with or without ketosis, neonates, critically ill patients, or for
diagnosis or screening of diabetes. When using the FreeStyle LibreLink app,
access to a blood glucose monitoring system is required as the app does not
provide one. Review all product information before use or contact Abbott Toll-
Free (855-632-8658) or visit
www.freestylelibre.us for detailed indications
for use and safety information.
FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes
Care Inc. in various jurisdictions. Other trademarks are the property of their
respective owners.
©2019 Abbott. ADC-09575 v1.0 01/19
References
- FreeStyle Libre Continuous Glucose Monitoring | FreeStyle Libre US
- FreeStyle Libre Continuous Glucose Monitoring | FreeStyle Libre US
- LibreView
- Manual-Hub.com – Free PDF manuals!