FreeStyle Libre 14 day System (CGM)

CGM = continuous glucose monitoring

For illustrative purposes only. Not actual patient data.

Which sensor do I prescribe?
Is there an app for caregivers?	LibreLinkUp	N/A	LibreLinkUp
Are there glucose and signal loss alarms?	NO	YES¶	YES¶
Is there an urgent glucose alarm? (<55 mg/dL)	NO	NO	YES#
What ages can use the system?	18+	4+	4+

For illustrative purposes only. Not actual patient data.

For illustrative purposes only. Not actual patient data.

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.

Abbott provides this information as a courtesy, 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.

* Data based on the number of users worldwide for 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.

† 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.

‡ The FreeStyle LibreLink 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 LibreLink app requires registration with LibreView.

§ 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.

ǁ The LibreLinkUp app is only compatible with certain mobile device and operating systems. Please check www.LibreLinkUp.com for more information about device compatibility before using the app. Use of the LibreLinkUp app requires registration with LibreView. LibreLinkUp is not intended to be used for dosing decisions. The user should follow instructions on the continuous glucose monitoring system. LibreLinkUp is not intended to replace self-monitoring practices as advised by a physician.

¶ Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device. You must have Critical Alerts enabled to receive alarms and alerts on your smartphone.

# 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.

** 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.

†† 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. Patients must meet Medicare eligibility coverage criteria LCD L33822 (July 2021). Local Coverage Article: Glucose Monitor Policy Article (A52464), July 2021.

‡‡ Based on a comparison of list prices of the FreeStyle Libre 14 day system versus competitors’ 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.

§§ Based on a comparison of list prices of the FreeStyle Libre 14 day system versus competitors’ CGM systems, assuming annual use of one receiver (or equivalent hardware) and quantity of transmitters and/or sensors according to use life.

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

¶¶ For Medicare patients, please visit freestylelibre.us/buying-guide for more information.

## Based on prescription claims for commercially insured patients using the FreeStyle Libre 14 day system. Does not include Medicare, Medicaid, and uninsured patients. The actual amount a patient pays may vary. The FreeStyle Libre 14 day system requires a prescription.

*** 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.

††† In comparison to the FreeStyle Libre 14 day reader.

‡‡‡ The user’s device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.

References: 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. https://doi.org/10.1007/s13300-016-0223-6. 2. Data on File. Abbott Diabetes Care. 3. Dunn, Timothy C., et al. “Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycemic measures: A European analysis of over 60 million glucose tests.” Diabetes Research and Clinical Practice 137, no. 37 (March 2018): 37-46. https://doi.org/10.1016/j.diabres.2017.12.015. 4. American Diabetes Association. “Standards of Medical Care in Diabetes – 2021.” Diabetes Care 44, supp. 1 (January 2021): S73-S84. https://doi.org/10.2337/dc21-S006. 5. FreeStyle Libre 14 day User’s Manual.

ADC-42705 Ver 2.0 03/22

Important Safety Information

FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.

FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre 2 or FreeStyle Libre 3 systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855‑632‑8658 or FreeStyleLibre.us for safety info.

FreeStyle Libre Pro: The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription.

IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.

CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment.

WARNINGS/LIMITATIONS: The FreeStyle Libre Pro System does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss may experience inaccurate results with this system. The FreeStyle Libre Pro System is not approved for pregnant women, persons on dialysis, or recommended for 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. Review all product information before use or contact Abbott Toll Free (855-632-5297) (or visit provider.myfreestyle.com) for detailed indications for use and safety information.

The product images are for illustrative purposes only.

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners.

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This website and the information contained herein is intended for use by residents of the United States.

ADC-45115 v11.0 02/23

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