Many patients require intensive insulin therapy to achieve optimal control, putting these patients at high risk for hypoglycemia and severe hypoglycemia.11,¶
0.55% overall mean change in HbA1c15,§
(at 2-4 months; 95% CI, −0.70% to −0.39%)
41% reduction in number of hypoglycemic events for T1DM3,§
(<55 mg/dL; −0.38/24-h day; P<0.0001)
44% reduction in number of hypoglycemic events for T2DM4,§
(<55 mg/dL; −0.12/24-h day; P=0.0017)
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), Jan 2020.
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's providers are 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.
* The FreeStyle Libre 2 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 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 Check Blood Glucose symbol and when your glucose alarms and readings from the system do not match symptoms or expectations..
‡ 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.
§ Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 system 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.
|| Includes ambulance visits, ED visits, and hospitalizations (29.3% rate of ambulance attendance per severe hypoglycemic event8; $214.47 per ambulance attendance, updated to $232 per medical care CPI9; 17% rate of ED visit per severe hypoglycemic event10; $1387 per ED visit and $17564 per hospitalization, updated to $1645 and $20840 per medical care CPI, respectively.11)
¶ Severe hypoglycemic events are defined by events requiring external third-party assistance, or leading to coma or convulsion.
# 2020 ADA recommendation for patients self-monitoring blood glucose (SMBG) on multiple-dose insulin or insulin pump therapy.
** Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
†† 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.
ǂǂ For FreeStyle Libre 14 day system: Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours.
§§ For FreeStyle Libre 2 system: Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours.
References: 1. Fokkert, Marion, Peter Van Dijk, Mireille Edens, Eglantine Barents, Jeanine Mollema, Robbert Slingerland, Reinold Gans, and Henk Bilo. “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 (2019). https://doi.org/10.1136/bmjdrc-2019-000809 2. Charleer, Sara, Christophe De Block, Liesbeth Van Huffel, Ben Broos, Steffen Fieuws, Frank Nobels, Chantal Mathieu, and Pieter Gillard. “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 (2019): 389–97. https://doi.org/10.2337/dc19-1610 3. Bolinder, Jan, Ramiro Antuna, Petronella Geelhoed-Duijvestijn, Jens Kröger, and Raimund Weitgasser. “Novel Glucose-Sensing Technology and Hypoglycaemia in Type 1 Diabetes: a Multicentre, Non-Masked, Randomised Controlled Trial.” The Lancet 388, no. 10057 (2016): 2254–63. https://doi.org/10.1016/s0140-6736(16)31535-5 4. Haak, Thomas, Hélène Hanaire, Ramzi Ajjan, Norbert Hermanns, Jean-Pierre Riveline, and Gerry Rayman. “Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial.” Diabetes Therapy 8, no. 1 (2016): 55–73. https://doi.org/10.1007/s13300-016-0223-6 5. American Diabetes Association “Economic Costs of Diabetes in the U.S. in 2017.” Diabetes Care 41, no. 5 (2018): 917–28. https://doi.org/10.2337/dci18-0007 6. Diabetes Control and Complications Trial Research Group. “The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.” New England Journal of Medicine 329, no. 14 (1993): 977-986. 7. Heller, S. R., B. M. Frier, M. L. Hersløv, J. Gundgaard, and S. C. L. Gough. “Severe Hypoglycaemia in Adults with Insulin-Treated Diabetes: Impact on Healthcare Resources.” Diabetic Medicine 33, no. 4 (2015): 471–77. https://doi.org/10.1111/dme.12844 8. Foos, Volker, Nebibe Varol, Bradley H. Curtis, Kristina S. Boye, David Grant, James L. Palmer, and Phil McEwan. “Economic Impact of Severe and Non-Severe Hypoglycemia in Patients with Type 1 and Type 2 Diabetes in the United States.” Journal of Medical Economics 18, no. 6 (2015): 420–32. https://doi.org/10.3111/13696998.2015.1006730 9. Bullano, Michael F., Maxine D. Fisher, W. Daniel Grochulski, Laura Menditto, and Vincent J. Willey. “Hypoglycemic Events and Glycosylated Hemoglobin Values in Patients with Type 2 Diabetes Mellitus Newly Initiated on Insulin Glargine or Premixed Insulin Combination Products.” American Journal of Health-System Pharmacy 63, no. 24 (2006): 2473–82. https://doi.org/10.2146/ajhp050552 10. Quilliam, Brian J., Jason C. Simeone, A. Burak Ozbay, and Stephen J. Kogut. "The incidence and costs of hypoglycemia in type 2 diabetes." The American Journal of Managed Care 17, no. 10 (2011): 673. 11. DCCT Research Group. “Epidemiology of Severe Hypoglycemia in the Diabetes Control and Complications Trial.” The American Journal of Medicine 90, no. 1 (1991): 450–59. https://doi.org/10.1016/0002-9343(91)90605-w 12. 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 13. American Diabetes Association. Standards of Medical Care in Diabetes—2021. Diabetes Care. 2021; 44 (suppl 1). 14. Data on file. Abbott Diabetes Care, Inc. 15. Evans, Mark, Zoë Welsh, Sara Ells, and Alexander Seibold. “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 (2020): 83-95.
ADC-17128 v5.0 08/21
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ADC-21099 v3.0 07/21