FreeStyle Libre 2 System

The FreeStyle Libre 2 system

GLUCOSE MONITORING WITHOUT FINGERSTICKS*, NOW WITH OPTIONAL ALARMS† TO LET YOU KNOW WHEN YOUR GLUCOSE IS TOO HIGH OR TOO LOW

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Description

Get The FreeStyle Libre 2 System Now

*Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the fi rst 12 hours.
Reference: 1. FreeStyle Libre 2 User’s Manual.
Indications and Important Safety Information
The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real-time alarms capability indicated for the management of diabetes in persons age 4 and older.**
WARNINGS/LIMITATIONS**: The System must not be used with automated insulin dosing (AID) systems, including closed-loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high
doses of vitamin C (more than 500 mg per day), as this may falsely raise your sensor readings. Failure to use the System according to the instructions for use may result in missing severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott toll-free 855-632-8658 or visit ** www.FreeStyleLibre.us for detailed indications for use and safety information.
**Please refer to www.FreeStyleLibre.us for the indications and important safety information.
The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. ©2020 Abbott. ADC-25744 v2.0 10/20

WITH THE FREESTYLE LIBRE 2 SYSTEM

Get CGM FreeStyle Libre 2 System Available in Michigan USA Through Insurance with Free Shipping to All 50 states of United States

NOW YOU KNOW

KNOW HOW TO ACCURATELY1 MONITOR YOUR GLUCOSE LEVELS

  • Check your glucose with a painless‡2,3 scan instead of
    fingersticks§
  • Significantly reduce your A1c‡4,5 with a continuous glucose monitoring (CGM) system for adults and children ages 4 years and above with diabetes
  • Conveniently access your glucose readings using the FreeStyle Libre 2 app* for iPhone and Android smartphones or a reader†II

What else to know about the FreeStyle Libre 2 system

For ages 4 & up

Our first CGM system is available for adults and children with diabetes, ages 4 years and above

Smartphone* or compatible reader†II

View your glucose readings on:

  • The FreeStyle Libre 2 app* for iPhone and Android smartphone users
  • A compatible reader†II

Real-time alarms¶

Customize your alarms¶ to notify you if you have a:

  • Low glucose reading#**
  • High glucose reading
  • Loss of signal between sensor and FreeStyle Libre 2 app* or reader†II

Try the FreeStyle Libre 2 system for FREE††

Sign up for the MyFreeStyle program to try the #1 CGM system in the WORLD‡‡6 at no cost!†† You will also receive 14 days of guided support to show you how a CGM system can help reveal personal insights about your body.

Already using the FreeStyle Libre 14 day system?

You can continue to use it! If you’d like to switch to the FreeStyle Libre 2 system, the MyFreeStyle program lets you try it for free.†† Or you can ask your healthcare professional for a new prescription. Both the FreeStyle Libre 14 day and FreeStyle Libre 2 systems are available through most pharmacies nationwide.§§

Applying your first sensor is as easy

As a courtesy, Abbott provides the most up-to-date information available, but it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payors.

* The FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app. Use of the FreeStyle Libre 2 app requires registration with LibreView.

† Medicare coverage is available for the FreeStyle Libre 2 system

if a compatible smartphone is used in conjunction with the FreeStyle Libre 2 reader to review glucose data. Medicare and other third-party payor criteria apply.

‡ Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional, real-time glucose alarms. Therefore, the study data is applicable to both products.

§ Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see the Check Blood Glucose symbol during the first 12 hours.

II The FreeStyle Libre 2 app and the FreeStyle Libre 2 reader

have similar but not identical features. Fingersticks are required for treatment decisions when you see the Check Blood Glucose symbol and when your glucose alarms and readings from the system do not match symptoms or expectations.

¶ Notifications will only be received when alarms are turned on and the sensor is within 20 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 2 User’s Manual for more information.

# The FreeStyle Libre 2 app also has a mandatory Urgent Low Glucose Alarm that lets users know when their glucose value is below 55 mg/dL.

** To get the Urgent Low Glucose Alarm on your phone with the FreeStyle Libre 2 app,

you will first need to start your FreeStyle Libre 2 sensor with your phone. If you do not start your FreeStyle Libre 2 sensor with your phone, you will not get the Urgent Low Glucose Alarm on your phone.

†† or ♢ Eligible patients will receive one (1) FreeStyle Libre 2 sensor for users with a compatible mobile phone operating system at $0 copay. The expiration date of the voucher is 60 days from the issue date. This program is available for patients with Type 1 and Type 2 diabetes; it is not available for patients with gestational diabetes. Only patients ages 18 and older are eligible to sign up and receive an offer for the FreeStyle Libre 2 sensor and patients ages 4-17 are eligible to receive an offer for the FreeStyle Libre 2 sensor through their parent or guardian. This offer is void where prohibited by law. Abbott may modify or rescind this offer at any time without notice. The discounts are not available to beneficiaries of Medicare, Medicaid or other federal or state healthcare programs or residents of Massachusetts, Puerto Rico and other US territories. The free FreeStyle Libre 2 sensor is provided as a sample and is limited to one NDC per eligible person. The FreeStyle Libre 2 sensor cannot be re-sold, traded nor submitted to any third-party payer for reimbursement and is not provided as any inducement for future purchases. The free sample card is not health insurance.

‡‡ Data based on the number of users worldwide

FreeStyle Libre family of personal CGMs compared to the number of users for other leading personal CGM brands and based on CGM sales dollars compared to other leading personal CGM brands.

§§ Participating pharmacies are subject to change without notice. Product availability may vary by retailer.

References: 1.

FreeStyle Libre 2 User’s Manual. 2. Haak, Thomas, et al. “Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-treated Type 2 Diabetes: a Multicentre, Open-label Randomised Controlled Trial.” Diabetes Therapy 8, no. 1 (February 2017): 55-73. https://doi.org/10.1007/s13300-016-0223-6. 3. Al Hayek, Ayman A., Robert A. Asirvatham, and Mohamed A. Al Dawish. “Acceptability of the FreeStyle Libre Flash Glucose Monitoring System: The Experience of Young Patients With Type 1 Diabetes.” Clinical Medical Insights: Endocrinology and Diabetes 13 (March 2020): 1-7. https://doi.org/10.1177/1179551420910122. 4. Evans, Mark, et al. “The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: a Meta-analysis of Clinical Trials and Real-world Observational Studies.” Diabetes Therapy 11, no. 1 (January 2020): 83-95. https://doi.org/10.1007/s13300-019-00720-0. 5. Kroeger, Jens, Peter Fasching, and Helene Hanaire. “Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes.” Diabetes Therapy 11, no. 1 (January 2020): 279-291. https://doi.org/10.1007/s13300-019-00741-9. 6. Data on File. Abbott Diabetes Care.

 

FreeStyle Libre 2 system | Michigan USA

See what makes the FreeStyle Libre 2 system

the #1 continuous glucose monitor worldwide! Discover the FreeStyle Libre 2 system Get ready to make fingersticks a thing of the past!

continuous glucose monitoring (CGM) system | Michigan USA 

What is it?

The freestyle libre 2 system flash glucose monitoring system sensor is a continuous glucose monitoring (CGM) system consisting of a smartphone app or a handheld reader and a glucose sensor worn on the back of the upper arm.

continuous glucose monitoring (CGM) system | Michigan USA

 

How does it work?

The sensor uses a thin, flexible filament inserted just under the skin to measure glucose levels every minute.

continuous glucose monitoring (CGM) system | Michigan USA 

How do you use it?

Use your smartphone or handheld reader to scan the glucose sensor with a painless,1 one-second scan to replace fingersticks.

The FreeStyle Libre 2 system reader

Each painless,1 one-second scan shows:

FreeStyle Libre 14 day system | Michigan USA

Want to trade in routine fingersticks for continuous data points?

Use the handheld reader or smartphone to scan the sensor as often as you like, even through clothing.II

Reporting capability Stores 90 days of glucose data. Downloading data from the FreeStyle Libre 2 day system to the LibreView software allows for even more in-depth analysis of your glucose data.

Convenience Compact, lightweight, and includes a built-in FreeStyle Precision Neo test strip port for blood glucose testing.
 
User-friendly Has a backlit color touchscreen for visibility in the dark.
 

FreeStyle Libre 14 day system | Michigan USA

 

 

 

Sensor Glucose Readings

The Sensor Glucose Readings screen appears after you use the reader or smartphone to scan your sensor. Your reading includes your current glucose reading, a glucose trend arrow indicating which way your glucose is headed.

and a graph showing your 8 hour glucose history.

FreeStyle Libre 14 day system | Michigan USA

 

 

Daily Patterns

A graph showing the pattern and variability of your sensor glucose over a typical day. The thick black line shows the midpoint of your glucose readings. The gray shading represents a range of your sensor readings.

Note: Daily Patterns needs at least 5 days of glucose data.

FreeStyle Libre 14 day system | Michigan USA

 

 

Low Glucose Events

This view provides information about the number of low glucose events measured by your sensor. The total number of events is displayed above the graph. The bar graph displays the low glucose events in four different 6-hour periods of the day. Use the arrows to view your glucose data collected over the last 7, 14, 30, or 90 days. Low glucose events are recorded when glucose readings are lower than 70 mg/dL for longer than 15 minutes.

FreeStyle Libre 14 day system | Michigan USA

 

 

 

Time In Target

Shows the percentage of time your sensor readings were above, below, and within your target glucose range.††

FreeStyle Libre 14 day system | Michigan USA

 

 

 

Visual Alerts

If your glucose reading is rapidly changing, below 70 mg/dL.

or projected to be below 70 mg/dL, or if there is no glucose number or trend arrow, you will see a visual alert, the Check Blood Glucose symbol. When you see this symbol, do a blood glucose test before making treatment decisions.

The FreeStyle Libre 2 system sensor

 

FreeStyle Libre 14 day system | Michigan USA

 
Small size and comfortable to wear1 About the size of 2 stacked US quarters, the sensor may be scanned through clothing.||
 
Painless application1 Painless1 and easy to apply. A very thin filament sits just under the skin to measure interstitial fluid.
 
Accurate5 sensor readings No fingerstick calibration required, and the system has no interference with medications containing acetaminophen.6
 
Water resistant# Stays on the body for up to 14 days, and can be worn while swimming,# showering, or exercising.
 
Continuous monitoring Measure your glucose every minute, and stores glucose readings every 15 minutes**
 
 

Getting started with the sensor

continuous glucose monitoring (CGM) system | Michigan USA 

Choosing the site

Select an area on the back of your upper arm, avoiding areas with moles, scarring, or recent insulin injections.‡‡

Select a different site than the one most recently used.

continuous glucose monitoring (CGM) system | Michigan USA 

Preparing your skin

Preparing your skin is an important step toward ensuring adhesion. Our sensor adhesion guide in our Support section suggests solutions to help overcome common skin surface conditions.

continuous glucose monitoring (CGM) system | Michigan USA 

Applying the sensor

The sensor pack and sensor application are packaged as a set (separately from the reader).§§

Applying the sensor

continuous glucose monitoring (CGM) system | Michigan USA

Open the sensor pack by peeling off the lid completely. Unscrew the cap from the sensor applicator and set the cap aside.II II

Line up the dark mark on the sensor applicator with the dark mark on the sensor pack. On a hard surface, press down firmly on the sensor applicator until it comes to a stop.¶¶
 
Place the sensor applicator over the prepared site and push down firmly until the sensor is in place.##
 
Make sure the sensor is secure after application.*** Put the cap back on the sensor applicator. Discard the used sensor pack and sensor applicator per local regulations.

Please refer to the complete application for Applying Your Sensor in the FreeStyle Libre2 system User Manual.

Learn how to keep your sensor in place.  DOWNLOAD SENSOR ADHESION GUIDE

* Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours. †Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device.

Indications and Important Safety Information

Freetyle Libre 2 System: FreeStyle Libre 2 Flash Glucose Monitoring system is a continuous glucose monitoring (CGM) devices 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 require 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 Check 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 systems contain small parts that may be dangerous if swallowed. The system is not approved for pregnant women, persons on dialysis, or critically-ill population. 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 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. The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are owned by Abbott. Other trademarks are the property of their respective owners. ©2020 Abbott. ADC-22410 v1.0 07/20

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