The easy-to-use‡2,3 FreeStyle Libre 2 system is one-third of the cost of other CGM systems.*§1
CGM = continuous glucose monitoring
For illustrative purposes only.
Not actual patient data.
The Centers for Medicare & Medicaid Services (CMS) published an Interim Final Rule4 on May 8th, 2020 that they will not enforce the clinical criteria for continuous glucose monitors during the COVID-19 public health emergency for Medicare patients with diabetes. Physicians and suppliers continue to be responsible for reasonable and necessary documentation to support product use.*5
As a healthcare provider, you now have greater flexibility to allow more of your diabetic patients to better manage‡‡ their glucose by using the FreeStyle Libre 2 system.‡2,3,6 Click here to learn more.
* As a courtesy to its customers, 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 of payment for our products or reimburse customers for claims that are denied by third party payors.
† Based on a comparison of list prices of the FreeStyle Libre 2 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.
‡ Data from this study was collected with the outside US version of 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.
§ Based on a comparison of list prices of the FreeStyle Libre 2 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. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
ǁ 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.
¶ 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.
# Medicare coverage is available for the FreeStyle Libre 2 system if a smartphone with the FreeStyle Libre 2 app is used in conjunction with the FreeStyle Libre 2 reader to review glucose data. Medicare coverage is not available if a patient never uses the FreeStyle Libre 2 reader, and patients must meet other applicable coverage criteria. See Local Coverage Determination: Glucose Monitors (L33822), July 2021 and Local Coverage Article: Glucose Monitors (A52464), July 2021
** Participating pharmacies are subject to change without notice. Product availability may vary by retailer.
†† Patients must meet Medicare eligibility coverage criteria. Local Coverage Article: Glucose Monitor Policy Article (A52464), July 2021
‡‡ Compared to self-monitoring blood glucose testing.
References: 1. Data on File. Abbott Diabetes Care. 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. Campbell, Fiona M., et al. “Outcomes of Using Flash Glucose Monitoring Technology by Children and Young People With Type 1 Diabetes in a Single Arm Study.” Pediatric Diabetes 19, no. 7 (November 2018): 1294-1301. https://doi.org/10.1111/pedi.12735. 4. On May 8, 2020, CMS published a second interim final rule with comment, CMS-5531-IFC, that expanded the non-enforcement of clinical indications of coverage to therapeutic continuous glucose monitors (CGMs). This IFC also clarified that statutory reasonable and necessary statutory requirements are not being waived due to the PHE. https://www.govinfo.gov/content/pkg/FR-2020-05-08/pdf/2020-09608.pdf. 5. CMS Issues Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC)— Covid-19 Public Health Emergency — Revised June 29, 2020, https://www.cgsmedicare.com/jc/pubs/news/2020/06/cope17942/html 6. Bolinder, Jan, et al. "Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial." The Lancet 10057, no. 388 (September 2016): 2254-2263. https://doi.org/10.1016/S0140-6736(16)31535-5.
ADC-42747 Ver 1.0 09/21
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.
No use of any Abbott trademark, trade name, or trade dress in this site may be made without prior written authorization of Abbott Laboratories, except to identify the product or services of the company.
This website and the information contained herein is intended for use by residents of the United States.
ADC-45115 v6.0 12/22
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