FREESTYLE LIBRE 2 SENSOR

ABB7194001

HCPCS: K0553

Use your smartphone* to scan the glucose sensor with a one-second scan to replace fingersticks .

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

The FreeStyle Libre 14 day system is a continuous glucose monitoring (CGM) system consisting of the FreeStyle LibreLink app* and a glucose sensor worn on the back of the upper arm

  • CURRENT GLUCOSE READING
    Text to speech option, when enabled

  • TREND ARROW
    Indicates how glucose is changing

  • GLUCOSE HISTORY
    Up to the last 8 hours

  • ADD NOTE
    Track food, insulin use, exercise, and other events

  • REAL TIME ALERTS
    Low glucose, high glucose, signal loss

FAQ

What if the FreeStyle Libre 2 sensor falls off before 14 days of use?

Replace the FreeStyle Libre 2 sensor and start a new sensor. If the sensor falls off early, please call us at 1-800-915-5924.

What happens to the FreeStyle Libre 2 sensor after the 14 day wear period?

After 14 days of wear, the reader notifies you that the FreeStyle Libre 2 sensor has ended and should be replaced with a new sensor.

Can a user still scan the FreeStyle Libre 2 sensor and get the last 8 hours of data after the sensor has ended after 14 days?

The user is provided with one last opportunity to scan the FreeStyle Libre 2 sensor after the 14 days have ended.

Does the FreeStyle Libre 2 system contain latex?

The FreeStyle Libre 2 system does not contain any latex.

Can the FreeStyle Libre 2 sensor be applied to tattooed skin?

Yes, there is no interaction expected between tattoo ink and the FreeStyle Libre 2 sensor. It is advised to avoid areas with scars, moles, stretch marks or lumps when applying the sensor.

Why do the numbers on the FreeStyle Libre 2 sensor pack and sensor applicator need to match?

The FreeStyle Libre 2 sensor pack and sensor applicator need to match because the sensor is factory calibrated. Information about the calibration of the sensing element (also known as the sensor tip) is programmed in the sensor at the factory and these two components must be used together.

What happens if the FreeStyle Libre 2 sensor is worn beyond 14 days?

The FreeStyle Libre 2 sensor automatically stops collecting glucose data and should be removed 14 days after being started. Three days before the sensor ends, it tells users with the first scan of each day. In the final 8 hours, it tells users with each scan. The sensor should be replaced with a new sensor.

What are the potential skin reactions to the FreeStyle Libre 2 sensor?

Some individuals may be sensitive to the adhesive that keeps the sensor attached to the skin. If you notice significant skin irritation around or under your sensor, remove the sensor and stop using the FreeStyle Libre 2 system. Contact your health care professional before continuing to use the FreeStyle Libre 2 system.

Were there any skin reactions reported by patients wearing the FreeStyle Libre 2 sensor?

In the adult study, mild skin irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion site and adhesive area by a small number of subjects (6.8%)1.

Were there any adverse events reported by patients wearing the FreeStyle Libre 14 day or FreeStyle Libre 2 sensors?

No device related serious adverse events occurred during the studies. In the Adult study, mild skin irritations, such as erythema, bruising, bleeding, and scabbing were reported around the insertion site and adhesive area by a small number of subjects (6.8%). Pain was mostly reported as none with only one instance of mild pain. In the Pediatric study, there were 8 instances of erythema (4 “well-defined redness”, and 4 “slight pink”), 5 instances of edema (3 slight edema, 2 slight edema with defined edges), 2 instances of mild bleeding, one instance of mild induration and one instance of mild rash1.

Is there any problem with the FreeStyle Libre 2 sensor if you sweat a lot?

Intense exercise may cause your FreeStyle Libre 2 sensor to loosen due to sweat or movement of the sensor. If the sensor is becoming loose or if the sensor tip is coming out of your skin, you may get no readings or unreliable low readings. Remove and replace your sensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the sensor. Contact Customer Service if your sensor becomes loose or falls off before the end of the wear period. Customer Service is available at 1-855-632-8658 7 days a week from 8AM to 8PM Eastern Standard Time.

What if the user needs to remove the FreeStyle Libre 2 sensor before 14 days (or if it falls off)?

A FreeStyle Libre 2 sensor that has been removed or that has fallen off cannot be reused. Users should replace the sensor and start a new sensor. The FreeStyle Libre 2 reader will identify that it is a new sensor and ask users if they want to start it.

Can a user still scan the FreeStyle Libre 2 sensor and get the last 8 hours of data after the sensor has ended after 14 days?

The user is provided with one last opportunity to scan the FreeStyle Libre 2 sensor after the 14 days have ended. The reader will acquire any data remaining on the sensor that was obtained prior to the end of the 14 day wear period.

When I scan my FreeStyle Libre 2 sensor, the reader says Sensor Ended, but I have not worn my sensor for the intended wear period. What should I do?

If for any reason the FreeStyle Libre 2 sensor stops working, please call Customer Service at 1-800-915-5924.

The FreeStyle Libre 2 sensor will expire within 14 days, can I still start the sensor?

Do not use the FreeStyle Libre 2 sensor past the expiration date. If your sensor expires during the 14 day wear, start a new sensor before the sensor expires.

Will you update the FreeStyle Libre 2 sensors to last longer than 14 days?

At this time, there are no current plans to update the FreeStyle Libre 2 sensors to last beyond the 14 days. Research has shown that 14 days of glucose data is sufficient to produce daily glucose patterns with certainty approaching 90%1.

Does the expiration date on the FreeStyle Libre 2 sensor indicate the last day the user can apply the sensor, or the last day it can be used?

The expiration date indicates the last day you can use the sensor. Do not use the FreeStyle Libre 2 sensor past the expiration date. If your sensor expires during the 14 day wear, start a new sensor before the sensor expires.

Why can't the FreeStyle Libre 2 sensor be worn on the abdomen?

The FreeStyle Libre 2 system is only approved for use on the back of the upper arm as this was used to collect data in our pivotal clinical studies.

How big is the FreeStyle Libre 2 sensor?

The FreeStyle Libre 2 sensor is 5 mm in height and 35 mm in diameter, which is roughly the size of two quarters stacked together.

Can users bathe, shower, swim or exercise while wearing a FreeStyle Libre 2 sensor?

Yes, the FreeStyle Libre 2 sensor is water resistant and will continue working as long as it is not submerged more than 3 feet or kept underwater longer than 30 minutes at a time.

Can an over-bandage be used with the FreeStyle Libre 2 sensor?

Yes, an over-bandage* can be used with the FreeStyle Libre 2 system.

How long can the FreeStyle Libre 2 sensor be worn?

The FreeStyle Libre 2 sensor is designed to provide accurate1 glucose readings for up to 14 days.

Can users get a glucose reading by scanning a FreeStyle Libre 2 sensor through their clothing?

Yes, the FreeStyle Libre 2 reader can capture data from the sensor when it is within 1cm to 4cm of the sensor.

How many glucose readings can be taken while the FreeStyle Libre 2 sensor is being worn?

Users can take as many glucose readings as they want while the FreeStyle Libre 2 sensor is being worn. A new glucose reading is provided every minute1.

If the FreeStyle Libre 2 sensor is storing glucose readings every 15 minutes, does that mean the user will get the same glucose reading if the sensor is scanned again within the same 15-minute interval?

No, the user can get an updated glucose reading every minute1 when they scan the FreeStyle Libre 2 reader over the sensor.

What will happen if a user scans their FreeStyle Libre 2 sensor frequently, for example, every 30 seconds?

Users can scan their FreeStyle Libre 2 sensor as often as they want, but the reading will not update more frequently than every 60 seconds.

What happens to the FreeStyle Libre 2 sensor if it is worn outside of the recommended temperature range?

If the FreeStyle Libre 2 sensor stops working due to extreme temperature the reader will display an error message E-1. The sensor will resume recording glucose readings again once it is within the temperature range again.

How is the FreeStyle Libre 2 sensor applied to the body?

The FreeStyle Libre 2 sensor is applied to the back of the upper arm with a simple, disposable device called an applicator. When the sensor is applied, a small (5mm) filament is inserted just under the skin, and held in place with a small adhesive pad.

Will the user feel the FreeStyle Libre 2 sensor while wearing it?

In a study conducted by Abbott Diabetes Care, 93.4%1of adult patients surveyed (n=30) did not feel discomfort under the skin while wearing the FreeStyle Libre 2 sensor.

Should the FreeStyle Libre 2 sensor be removed if there is bleeding?

If there is bleeding that does not stop, remove the FreeStyle Libre 2 sensor and contact your health care professional.

Is it necessary to apply a FreeStyle Libre 2 sensor in a different location if I feel discomfort or in case of a mis-application?

To prevent discomfort or skin irritation, you should select a different site other than the one most recently used. sensor placement is not approved for sites other than the back of the arm. If placed in other areas, the sensor may not function properly.

Are there products I can use to help the FreeStyle Libre 2 sensor to stick?

Yes, there are a number of product options to help. Refer to the FreeStyle Libre 2 sensor Adhesion Guide for details.

How do you remove the FreeStyle Libre 2 sensor?

Pull up the edge of the adhesive that keeps your FreeStyle Libre 2 sensor attached to your skin. Slowly peel away from your skin in one motion. Note: Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol.

How frequently does the FreeStyle Libre 2 sensor capture and store glucose readings?

The FreeStyle Libre 2 sensor automatically captures the glucose concentration in the interstitial fluid every minute. It also automatically records the glucose concentration every 15 minutes, storing that data in a rolling 8-hour log.

How do users know the FreeStyle Libre 2 sensor is working correctly?

The FreeStyle Libre 2 sensor is working correctly if you can get a glucose reading after a 1 second scan. If you do not get a reading, please refer to your User’s Manual for further information on glucose error messages.

What is the expiration date for my FreeStyle Libre 2 system?

Please refer to sensor packaging for the expiry date.

During what situations/scenarios would one get Check Sensor messages when using a FreeStyle Libre 2 sensor?

A "Check Sensor" Message may occur when the sensor tip may not be under your skin. Try to start your sensor again. If reader displays “Check sensor” again, your sensor was not applied properly. Apply and start a new sensor.

Can I start a 2nd FreeStyle Libre 2 sensor when I have less than 24 hours left on my old sensor?

No, the FreeStyle Libre 2 reader may only connect to a single sensor. At the completion of the sensor-wear, a new sensor can be started.


Specifications

Sensor Size: 5 mm height and 35 mm diameter

Sensor Weight: 5 grams

Sensor Power Source: 1 silver oxide battery

Sensor Life: Up to 14 days

Sensor Memory: 8 hours (glucose reading stored every 15 minutes)

Sensor Operating Temperature: 10°C to 45°C

Sensor Applicator and Sensor Pack Storage Temperature: 4°C to 25°C

Operating and Storage Relative Humidity: 10%-90%, non-condensing

Sensor Water Resistance: IP27: Can withstand immersion into one meter (3 ft) of water up to 30 minutes

Operating and Storage Altitude: -381 meters (-1,250 ft) to 3048 meters (10,000 ft)