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 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.
† FreeStyle Libre 2 system is indicated for use in people with diabetes age 4 and older.
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. 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. 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. Evans, Mark, et al. "The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: a Meta-analysis of Clinical Trials and Real-world Observational Studies." Diabetes Therapy 11, no. 1 (January 2020): 83-95. https://doi.org/10.1007/s13300-019-00720-0. 5. Kroeger, Jens, Peter Fasching, and Helene Hanaire. "Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes." Diabetes Therapy 11, no. 1 (January 2020): 279-291. https://doi.org/10.1007/s13300-019-00741-9. 6. Miller, Eden, et al. "85-LB: Freestyle Libre System Use Associated with Reduction in Acute Diabetes Events and All-Cause Hospitalizations in Patients with Type 2 Diabetes without Bolus Insulin." Diabetes 69, supp. 1 (June 2020). https://doi.org/10.2337/db20-85-LB. 7. Hirsch, Irl B. et. al. "Utilization of Continuous Glucose Monitors is Associated with Reduction in Inpatient and Outpatient Emergency Acute Diabetes Events Regardless of Prior Blood Test Strip Usage." Diabetes 69, supp. 1 (June 2020). https://doi.org/10.2337/db20-875-P. 8. Wright, Eugene E., et al. "Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy." Diabetes Spectrum (February 2021): ds200069. https://doi.org/10.2337/ds20-0069. 9. Lang, Jordan, Sujit R. Jangam, Timothy C. Dunn, Gary Hayter. "972-P: Expanded Real-world Use Reaffirms Strong Correlation between Scanning Frequency of Flash Glucose Monitoring and Glucose Control." Diabetes 68, no. 1 (June 2019). https://doi.org/10.2337/db19-972-P. 10. Calliari, Luis Eduardo, et al. "Real‑world flash glucose monitoring in Brazil: can sensors make a difference in diabetes management in developing countries?" Diabetology & Metabolic Syndrome 12, no. 3 (January 2020). https://doi.org/10.1186/s13098-019-0513-z.
11. Roussel, Ronan, et al. "68-OR: Dramatic drop in ketoacidosis rate after FreeStyle Libre system initiation in type 1 and type 2 diabetes in France, especially in people with low self-monitoring of blood glucose (SMBG): a nationwide study." Diabetes 69, supp. 1 (June 2020). https://doi.org/10.2337/db20-68-OR. 12. Charleer, Sara et al. “Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living With Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study.” Diabetes Care 43, no. 2 (February 2020): 389-397. doi:10.2337/dc19-1610. 13. Data on File. Abbott Diabetes Care.
14. Fokkert, Marion, et al. “Improved Well-Being and Decreased Disease Burden After 1-Year Use of Flash Glucose Monitoring (FLARE-NL4).” BMJ Open Diabetes Research & Care 7, no. 1 (December 2019): e000809. https://doi.org/10.1136/bmjdrc-2019-000809. 15. Al Hayek, Ayman A., Robert A. Asirvatham, and Mohamed A. Al Dawish. “Evaluation of FreeStyle Libre Flash Glucose Monitoring System on Glycemic Control, Health-Related Quality of Life, and Fear of Hypoglycemia in Patients with Type 1 Diabetes.” Clinical Medicine Insights: Endocrinology and Diabetes 10 (December 2017): 1-6. https://doi.org/10.1177/1179551417746957.
ADC-42746 Ver 1.0 02/22
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.
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ADC-45115 v5.0 05/22
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