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CGM = Continuous Glucose Monitoring

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*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). (www.govinfo.gov/content/pkg/FR-2020-05-08/pdf/2020-09608.pdf) The Durable Medical Equipment Medicare Administrative Contractors (DME MAC) subsequently issued guidance on the IFC policies, including discussing that clinical indications for coverage in the therapeutic CGM LCD (Glucose Monitors, L33822) will not be enforced. See “CMS Issues Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC) – COVID-19 Public Health Emergency – Revised May 21, 2020.” (www.cgsmedicare.com/jc/pubs/news/2020/05/cope1733) As a courtesy to its customers, Abbott provides the most accurate and 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.

FreeStyle Libre 14 day sensors communicate with the FreeStyle Libre 14 day readers that started them or the FreeStyle LibreLink app that started it. A sensor started by the FreeStyle Libre 14 day reader will also communicate with the FreeStyle LibreLink app once the FreeStyle LibreLink app is used to scan the sensor.

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. See Local Coverage Determination: Glucose Monitors (L33822) and Local Coverage Article: Glucose Monitors (A52464), Jan 2020.

 

ADC-37051 Ver 1.0 04/21

Indications and Important Safety Information

FreeStyle Libre 14 day system: The FreeStyle Libre 14 day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires 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 FreeStyle Libre 14 day system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The FreeStyle Libre 14 day 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. For full indications for use and safety information, see more here.

FreeStyle Libre 2 system: The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*

WARNINGS/LIMITATIONS*: The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.

*Please refer to www.freestylelibre.us for the indications and important safety information.

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ADC-29111 Ver 6.0 04/21