Unsurpassed 14 day accuracy1,2 for adults and children with diabetes (ages 4 and older) and optional, real-time glucose alarms,† with readings every minute.1
The FreeStyle Libre Portfolio demonstrated a reduction in hypoglycemic events5,6,‡ and resource utilization,3,4,‡ key drivers in diabetes costs.
Many patients require intensive insulin therapy to achieve optimal control, putting these patients at high risk for hypoglycemia and severe hypoglycemia.ǁ
0.55% overall mean change in HbA1c16,‡
(at 2-4 months; 95% CI, −0.70% to −0.39%)
41% reduction in number of hypoglycemic events for T1DM5,‡
(<55 mg/dL; −0.38/24-h day; P<0.0001)
44% reduction in number of hypoglycemic events for T2DM6,‡
(<55 mg/dL; −0.12/24-h day; P=0.0017)
* Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
† Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device.
‡ 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)
ǁ Severe hypoglycemic events are defined by events requiring external help, or leading to coma or convulsion.
¶ 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.
# 2021 ADA recommendation for patients self-monitoring blood glucose (SMBG) on multiple-dose insulin or insulin pump therapy.
** 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.
†† For FreeStyle Libre 14 day system: 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.
ǂǂ 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. FreeStyle Libre 2 User’s Manual. 2. Unger, Jeff, Pamela Kushner, and John E. Anderson. "Practical guidance for using the FreeStyle Libre flash continuous glucose monitoring in primary care." Postgraduate Medicine 132, no. 4 (2020):305-313. https://doi.org/10.1080/00325481.2020.1744393. 3. 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 and Care 7, no. 1 (2019). 4. 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 (2020): 389-397. 5. 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): 2254-2263. 6. 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 (2017): 55-73. 7. Yang, Wenya, Timothy M. Dall, Kaleigh Beronjia, Janice Lin, April P. Semilla, Ritashree Chakrabarti, and Paul F. Hogan; American Diabetes Association. “Economic Costs of Diabetes in the US in 2017.” Diabetes Care 41, no. 5 (2018): 917-928. 8. 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 (2016): 471-477. 9. 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): 420-432. 10. 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): 2473-2482. 11. 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. 12. Danne, Thomas, Revital Nimri, Tadej Battelino, Richard M. Bergenstal, Kelly L. Close, J. Hans DeVries, Satish Garg et al. “International consensus on use of continuous glucose monitoring.” Diabetes Care 40, no. 12 (2017): 1631-1640. 13. Calliari, Luis Eduardo P., Marcio Krakauer, Andre Gustavo Daher Vianna, Yashesvini Ram, Douglas Eugenio Barbieri, Yongjin Xu, and Timothy C. Dunn. “Real-world flash glucose monitoring in Brazil: can sensors make a difference in diabetes management in developing countries?” Diabetology & Metabolic Syndrome 12, no. 1 (2020): 1-7. 14. American Diabetes Association. “7. Diabetes technology: Standards of Medical Care in Diabetes—2021.” Diabetes Care 44, no. Supplement 1 (2021):S85–S99. 15. Data on file. Abbott Diabetes Care. 16. 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 v4.0 01/21
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.
The shape of the circle sensor unit, FreeStyle, Libre, and related brand marks are owned by 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 the prior written authorization of Abbott Laboratories, except to identify the product or services of the company. Product images are for illustrative purposes only.
ADC-25347 v3.0 12/20