In the real world, increased engagement with the FreeStyle Libre Portfolio strongly relates to improved glycemic control.1,2,*
* 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.
† 2021 ADA recommendation for patients self-monitoring blood glucose (SMBG) on multiple-dose insulin or insulin pump therapy.
‡ Compared to patients using SMBG.
§ Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device.
ǁ In comparison to FreeStyle 14 day reader users.
¶ In comparison to FreeStyle LibreLink app patients not sharing with their physicians.
# LibreView is developed, distributed, and supported by Newyu, Inc. The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
** The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app.
†† Use of the FreeStyle LibreLink app requires registration with LibreView, a service provided by Abbott and Newyu, Inc.
ǂǂ 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 and FreeStyle Libre 14 day readers. Patients must meet Medicare eligibility coverage criteria. Local Coverage Article: Glucose Monitor Policy Article (A52464), May 2017.
§§ The LibreLinkUp app is only compatible with certain mobile devices and operating systems. Please check www.librelinkup.com for more information about device compatibility before using the app. Use of the LibreLinkUp app requires registration with LibreView, a service provided by Abbott and Newyu, Inc.
ǁǁ 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.
¶¶ 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. Dunn, Timothy, et al. “Evidence of a Strong Association Between Frequency of Flash Glucose Monitoring and Glucose Control Measures During Real-World Usage.” E-poster presentation presented at the 10th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), Paris, France, February 15-18, 2017. 2. Jangam, Sujit, et al. “Sustained improvement in glycemic control following flash glucose monitoring: a worldwide observational analysis.” Poster presentation presented at the 11th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), Vienna, Austria, February 14-17, 2018. 3. 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. 4. Lang, Jordan, Sujit Jangam, Timothy Dunn, and Gary Hayter. “972-P: Expanded Real-World Use Reaffirms Strong Correlation between Scanning Frequency of Flash Glucose Monitoring and Glucose Control.” (2019): 972-P. 5. Dunn, Timothy C., Yongjin Xu, Gary Hayter, and Ramzi A. Ajjan. “Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: a European analysis of over 60 million glucose tests.” Diabetes Research and Clinical Practice 137 (2018): 37-46. 6. 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). https://doi.org/10.1136/bmjdrc-2019-000809. 7. FreeStyle Libre 2 User's Manual. 8. 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. 9. Data on file. Abbott Diabetes Care. 10. 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. 11. Campbell, Fiona M., Nuala P. Murphy, Caroline Stewart, Torben Biester, and Olga Kordonouri. “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 (2018): 1294-1301. 12. FreeStyle Libre 14 day User's Manual.
ADC-17129 v3.0 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.
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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