Facilitates better diabetes management,1,2,† and patients experienced fewer complications and reduced avoidable resource utilization.3,†
(<55 mg/dL; −0.38/24-h day; P<0.0001)
(<55 mg/dL; −0.12/24-h day; P=0.0017)
(at 2-4 months; 95% CI, −0.70% to −0.39%)
reduction in number of diabetes-related hospital admissions5,†
[over 12 months (P<0.05)]
reduction in acute diabetes events among patients with T2DM6,†
Several clinical organizations including the ADA, AACE, and ACE have published guidelines for the use of CGM in the management of diabetes.9,10 Highlights from the published guidelines are included below.
American Diabetes Association (ADA)
The ADA published diabetes treatment guidelines as part of the 2021 Standards of Medical Care in Diabetes, making the following clinical and access recommendations specific to CGM9:
American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE)
A 2019 consensus statement10 by the AACE and ACE on a comprehensive type 2 diabetes mellitus management algorithm describes the role of CGM, making the following clinical recommendations:
The role of CGM in reducing costs and complications
For therapeutic CGM, use the following billing codes:
* Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
† 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.
ǂ Cost savings results from removal of manual prior authorization (PA) process. Under pharmacy benefit, PA’s can either be eliminated or automated via smart PA.
§ Does not apply to Medicare and Medicaid.
|| 70-180 mg/dL.
¶ 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.
# 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. 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. 2. 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. 3. Deshmukh, Harshal, Emma G. Wilmot, Robert Gregory, Dennis Barnes, Parth Narendran, Simon Saunders, Niall Furlong et al. “Effect of flash glucose monitoring on glycemic control, hypoglycemia, diabetes-related distress, and resource utilization in the Association of British Clinical Diabetologists (ABCD) nationwide audit.” Diabetes Care 43, no. 9 (2020): 2153-2160. 4. 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. 5. 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. 6. Bergenstal, Richard M., Matthew SD Kerr, Gregory J. Roberts, Diana Souto, Yelena Nabutovsky, and Irl B. Hirsch. “69-OR: Freestyle Libre System Use Is Associated with Reduction in Inpatient and Outpatient Emergency Acute Diabetes Events and All-Cause Hospitalizations in Patients with Type 2 Diabetes.” (2020). Diabetes 69, no. Supplement 1 (2020). https://doi.org/10.2337/db20-69-or. 7. Battelino, Tadej, Thomas Danne, Richard M. Bergenstal, Stephanie A. Amiel, Roy Beck, Torben Biester, Emanuele Bosi et al. “Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range.” Diabetes Care 42, no. 8 (2019): 1593-1603. 8. 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." Diabetes 68, no. 1 (June 2019). DOI: https://doi.org/10.2337/db19-972-P. 9. American Diabetes Association. “7. Diabetes technology: Standards of Medical Care in Diabetes --2021.” Diabetes Care 44, no. Supplement 1 (2021):S85 -S99. 10. Garber, Alan J., Martin J. Abrahamson, Joshua I. Barzilay, Lawrence Blonde, Zachary T. Bloomgarden, Michael A. Bush, Samuel Dagogo-Jack et al. “Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm -2019 executive summary.” Endocrine Practice 25, no. 1 (2019): 69-100. 11. First DataBank, April 2020. 12. Centers for Medicare & Medicaid Services. Medicare Claims Processing. CMS publication 100-04. Published June 28, 2019. Accessed November 20, 2020. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4328CP.pdf.
ADC-17130 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