More time in range is associated with reduced HbA1c1
and fewer long-term health complications.2
Time in Range complements HbA1c1 with more actionable information than using HbA1c alone for a wide range of people with diabetes.
FreeStyle Libre 14 day system users spent 43% more time in range,3,* than patients using SMBG.
Facilitates better diabetes management4,5 and patients experienced fewer complications and reduced resource utilization6-8
(<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%)
[over 12 months (P<0.05)]
Several clinical organizations including the ADA, AACE, and ACE have published guidelines for the use of CGM in the management of diabetes.10,11 Highlights from the published guidelines are included below.
American Diabetes Association (ADA)
The ADA published diabetes treatment guidelines as part of the 2020 Standards of Medical Care in Diabetes, making the following clinical and access recommendations specific to CGM:
American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE)
A 2019 consensus statement11 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:
* (70-180 mg/dL)
Ɨ Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
ǂ Applicable to people with T1D who are not meeting glucose targets, are hypoglycemic unaware, and/or experience hypoglycemic episodes.
§ Applicable to people with T2D who are not meeting glucose targets.
|| Customer (including healthcare professionals and healthcare institutions) is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients.
¶ Abbott Diabetes Care (ADC) may not guarantee third-party coverage or payment for ADC products or reimburse customers (including healthcare professionals, healthcare institutions, consumers, and patients) for claims that are denied by third-party payers.
# 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.
References: 1. Battelino T, et al. [published online June 8, 2019]. Diabetes Care. 2019;42(8):1593-1603. 2. Beck RW, et al. Diabetes Care. 2019;42(3):400-405. 3. Lang J, et al. Expanded real-world use confirms strong association between frequency of flash glucose monitoring and glucose control. Diabetes Technol Ther. 2019;21(suppl 1):A-40. doi:10.1089/dia.2019.2525.abstracts 4. Bolinder J, et al. Lancet. 2016;388(10057):2254-2263. 5. Haak T, et al. Diabetes Ther. 2017;8(1):55-73. 6. Charleer S, et al. Diabetes Care. 2020;43(2):389-397. 7. Fokkert M, et al. BMJ Open Diabetes Res Care. 2019;7(1):e000809. doi:10.1136/bmjdrc-2019-000809 8. Kerr M, et al. CGM use associated with reduction in acute diabetes complications, even in patients using less than four test strips per day. Diabetes Technol Ther. 2020;22(suppl 1):A-55. doi:10.1089/dia.2020.2525.abstracts 9. Evans M, et al. [published online October 31, 2019]. Diabetes Ther. 2020;11:83-95. doi:10.1007/s13300-019-00720-0 10. American Diabetes Association. Diabetes Care. 2020;43(suppl 1):S77-S88. 11. Garber AJ, et al. Endocr Pract. 2019;25(1):69-100. 12. Centers for Medicare & Medicaid Services. Home blood glucose monitors. Medicare National Coverage Determinations Manual. CMS publication 100-03, chap 1, sec 40.2. Published February 15, 2019. Accessed April 3, 2020. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS014961 13. Centers for Medicare & Medicaid Services. Medicare Claims Processing. CMS publication 100-04. Published June 28, 2019. Accessed April 3, 2020. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R4328CP.pdf.
ADC-17130 v2.0 07/20
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 v2.0 09/20