FreeStyle Libre 14 day system

Real-time glucose readings with a painless¹ scan

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Description

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*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.
REFERENCE: 1. 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. DOI: 10.1007/s13300-016-0223-6.
Indications and Important Safety Information
FreeStyle Libre 14 day 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 system contains 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 circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. ©2020 Abbott. ADC-25128 v2.0 11/20

FreeStyle Libre 14 day system | Michigan USA

See what makes the FreeStyle Libre 14 day system

the #1 continuous glucose monitor worldwide! Discover the FreeStyle Libre 14 day system Get ready to make fingersticks a thing of the past!

continuous glucose monitoring (CGM) system | Michigan USA 

What is it?

The freestyle libre 14 day 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 14 day 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 14 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 14 day 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 complete application for Applying Your Sensor in the FreeStyle Libre 14 day 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 14 day System: FreeStyle Libre 14 day 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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