What is the FreeStyle Libre 3 System?

The FreeStyle Libre 3 System is a continuous glucose monitoring system that automatically sends glucose readings every minute directly to your smartphone* so you can act faster to avoid hypoglycemia. It has the same unsurpassed 14-day accuracy¹ as the FreeStyle Libre 2 System. Being the world’s smallest, thinnest^†, and most discreet² glucose sensor (smaller than two stacked pennies²), FreeStyle Libre 3 users can view glucose levels with a quick glance at your smartphone.*

What devices or apps does the FreeStyle Libre 3 sensor work with?

The FreeStyle Libre 3 Sensor is compatible only with the FreeStyle Libre 3 app.* Please visit https://www.freestyle.abbott/us-en/support.html for device compatibility.

What type of smartphone or operating systems are required to use the FreeStyle Libre 3 System?

The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app. Use of the FreeStyle Libre 3 app requires registration with LibreView.

Are other devices besides the app and sensor required?

No other devices are required besides the sensor and app on a compatible smartphone* for routine diabetes management. The FreeStyle Libre 3 System does not currently include a reader with a built-in blood glucose meter. Under conditions where blood glucose testing is required, any blood glucose meter system can be used.

Do I need to carry a separate blood glucose meter?

When using the FreeStyle Libre 3 app* the user must have access to a blood glucose meter because the app does not provide one. When the app displays the Check Blood Glucose symbol, a fingerstick is required for treatment decisions. Fingersticks are also required 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.

Do I need to scan the FreeStyle Libre 3 Sensor to get a glucose reading?

No, with the FreeStyle Libre 3 System you do not need to scan to receive a glucose reading. When your FreeStyle Libre 3 Sensor is paired with your smartphone, you will automatically^‡ see the latest glucose information after you open the FreeStyle Libre 3 app or when you receive an alarm* notification on your compatible smartphone^†.

Is the FreeStyle Libre 3 system indicated for people with Type 1 and Type 2 diabetes?

The FreeStyle Libre 3 system is cleared for the management of both type 1 and type 2 diabetes in persons age 4 and older.

How accurate is my glucose information?

The FreeStyle Libre 3 system uses technology that is proven to be accurrate¹, stable and consistent² for up to 14 days without fingersticks.* FreeStyle Libre 3 has an overall mean absolute relative difference (MARD) of 7.9%.¹

How many glucose readings are sent to the phone while the sensor is being worn?

The sensor measures glucose every minute¹ and automatically^‡ updates glucose values in the app every minute. Glucose readings are stored in the app every 5 minutes up to 14 days¹.

What types of alarms are provided with the FreeStyle Libre 3 System?

The FreeStyle Libre 3 System offers optional low and high glucose alarms, signal loss alarms, and a mandatory urgent low glucose alarm. Notifications will only be received when alarms are turned on and the sensor is within 33 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 3 User’s Manual for more information. Please visit https://www.freestyle.abbott/us-en/products/freestyle-libre-app.html for device compatibility.

What is the size of the FreeStyle Libre 3 Sensor?

The FreeStyle Libre 3 Sensor is the smallest and thinnest* CGM sensor available – it is approximately the size of two stacked pennies¹.

What do HI and LO results mean?

The HI and LO are symbols that indicate when results are beyond the reportable range. HI will be displayed when the result is above 400 mg/dL. LO will be displayed when the result is below 40 mg/dL. Follow the instructions in your User’s Manual¹ if you see these symbols.

How do you restore connection after a signal loss alarm?

To restore connection after a signal loss alarm, wait around 2-4 minutes after coming back into range (within 33 feet, unobstructed), or scan the sensor again.

What if I don’t have mobile phone service or Wi-Fi?

A Wi-Fi or a mobile data connection is only required for initial FreeStyle Libre 3 app* setup (downloading/ installing the app, creating an account, or signing in) and sharing your glucose information with your Health Care Professionals and LibreLinkUp^† users. The FreeStyle Libre 3 app does not require a Wi-Fi or a mobile data connection to scan your sensor, view your glucose readings, and receive alarms^‡. During periods when your phone is operating in a disconnected state, your readings will only be uploaded to LibreView^§ after a Wi-Fi or mobile data connection is restored.

Can the FreeStyle Libre 3 System be used on pets or animals?

No, the FreeStyle Libre 3 System has not been approved for use on animals.

Can the FreeStyle Libre 3 System be used by dialysis patients?

The FreeStyle Libre 3 System has not been evaluated for use by persons on dialysis.

Is FreeStyle Libre 3 cleared for use in pregnant women?

No, the System is not approved for use in pregnant women. Please see the FreeStyle Libre 3 User's Manual for more details¹.

Can you use FreeStyle Libre 3 if you do not have diabetes or have pre-diabetes?

The FreeStyle Libre 3 system is indicated for the management of diabetes in persons age 4 and older. The System is not indicated for use for patients without diabetes.

What substances could interfere with the results?

Taking ascorbic acid (vitamin C) supplements while wearing the Sensor may falsely raise Sensor glucose readings. Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event. Ascorbic acid can be found in supplements including multivitamins. Some supplements, including cold remedies such as Airborne® and Emergen-C®, may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor. See your health care professional to understand how long ascorbic acid is active in your body¹.

What is the optimal operating and storage altitude for the FreeStyle Libre 3 System?

The operating and storage altitude is -381 meters (-1,250 ft.) to 3,048 meters (10,000 ft.)¹.

Is the accuracy of the sensor consistent over the 14 day wear period?

The FreeStyle Libre 3 System is proven to be accurate¹, stable, and consistent* ² for up to 14 days without fingersticks**. Please refer to the FreeStyle Libre 3 User's Manual for more information.

Does the expiration date 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 3 Sensor past the expiration date. If your sensor expires during the 14 day wear, start a new sensor before the sensor expires.

How does the FreeStyle Libre 3 System accuracy compare to other CGMs?

The FreeStyle Libre 3 System meets the highest accuracy standards defined by FDA iCGM Special Controls for glucose <70mg/dL, as well as readings in the normal and high ranges. The FreeStyle Libre 3 System is the only iCGM with unsurpassed 14-day accuracy,¹ so patients can trust their glucose readings in the low, normal, and high ranges – no fingersticks required*.

What are the differences between interstitial fluid (ISF) and blood glucose (BG) readings?

Interstitial fluid glucose measurements are taken from the fluid within tissue while blood glucose measurements are taken directly from the blood. Sensor glucose values, which are based on interstitial fluid glucose levels, can be different from blood glucose levels (fingersticks), particularly during times when your blood glucose is changing quickly. For example, after eating, taking insulin, or exercising. When glucose levels are falling quickly, glucose readings from the Sensor may be higher than blood glucose levels. On the other hand, when glucose levels are rising quickly, glucose readings from the Sensor may be lower than blood glucose levels. [To learn more about sensor glucose vs. blood glucose, please visit https://www.freestyle.abbott/us-en/support.html]

If your glucose readings and alarms from the System do not match your symptoms or expectations, use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions.¹

How is the FreeStyle Libre 3 System different from past FreeStyle Libre systems?

The FreeStyle Libre 3 system offers the same benefits as the FreeStyle Libre 2 system, but now glucose readings and optional, real-time low¹ and high¹ glucose alarms* are automatically sent to your smartphone^† every minute¹. The FreeStyle Libre 3 system is indicated for the management of diabetes in people age 4 and older.

Can I use the FreeStyle Libre 3 Sensor and app while on an airplane?

You may use your FreeStyle Libre 3 System while on an aircraft, following any requests from the flight crew. You will not receive alarms or glucose readings while your phone is in airplane mode unless you enable Bluetooth¹.

Some airport full-body scanners include x-ray or millimeter radio-wave, which you cannot expose your System to. The effect of these scanners has not been evaluated and the exposure may damage the System or cause inaccurate results. To avoid removing your System, notify the Security Officer prior to proceeding through the airport security checkpoint and you may request another type of screening. If you do choose to go through a full-body scanner, you must remove your Sensor¹.

FreeStyle Libre 3 sensors can be exposed to common electrostatic (ESD) and electromagnetic interference (EMI), including airport metal detectors¹.

¹ FreeStyle Libre 3 User's Manual.

Did the price increase from the FreeStyle Libre 14 day system/FreeStyle Libre 2 system to the FreeStyle Libre 3 System?

Abbott is committed to expanding access to care and technology for people with diabetes. The FreeStyle Libre 3 System will be priced the same*¹ as the previous generations of the device^†. We are working closely with insurance companies to extend coverage to FreeStyle Libre 3 system** over the next few months, so that more patients can benefit from more affordable out-of-pocket costs. Please stay tuned as we release more information closer to product availability.

¹ Data on File, Abbott Diabetes Care

* Based on a comparison of list prices of the FreeStyle Libre 3 system versus previous generations of the FreeStyle Libre Personal CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any. Does not include Medicare, Medicaid, and uninsured patients.

** At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursment, and Medicaid eligibility may vary by state.

^† Medicare coverage is available for FreeStyle Libre 14 day systems for cell phone use if FreeStyle LibreLink is used in conjunction with the FreeStyle Libre 14 day readers. Medicare coverage is available for the FreeStyle Libre 2 system if the FreeStyle Libre 2 reader is used to review glucose data on some days every month. Medicare and other third party payor criteria apply. Patients must meet Medicare eligibility coverage criteria LCD L33822 (February 2022). Local Coverage Article: Glucose Monitor Policy Article (A52464), February 2022.

Does the FreeStyle Libre 3 System require a prescription?

Yes, the FreeStyle Libre 3 System requires a valid prescription.

Do I need a new prescription for the FreeStyle Libre 3 System if I already have a prescription for the FreeStyle Libre 2 or the FreeStyle Libre 14 day system?

Yes, the FreeStyle Libre 3 System requires a valid prescription.

Is the FreeStyle Libre 3 System covered for Medicare beneficiaries?

At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state.

When will FreeStyle Libre 3 System be compatible with pumps?

The Freestyle Libre 3 system can be used alone or in conjunction with digitally connected devices where the user manually controls actions for therapy decisions. Abbott continues to work with multiple companies to establish an end-to-end integrated diabetes ecosystem and we will provide more information on these partnerships as they develop.