CGM = continuous glucose monitoring
CGM = continuous glucose monitoring
FreeStyle Libre 2 and FreeStyle Libre 3 systems are indicated for use in people with diabetes age 4 and older.
Medicare coverage is available for FreeStyle Libre systems if their respective readers are used to review glucose data on some days every month. Medicare and other third-party payor criteria apply.
Abbott provides this information as a courtesy, 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 or payment for our products or reimburse customers for claims that are denied by third party payors.
* 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.
† Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 3 has the same features as FreeStyle Libre 14 day system with real-time glucose alarms. Therefore, the study data is applicable to both products.
‡ Data from this study was collected with the FreeStyle Libre 14 day system and FreeStyle LibreLink. FreeStyle Libre 3 has the same features as FreeStyle Libre 14 day system with real-time glucose alarms. Therefore, the study data is applicable to both products.
§ IMPACT Trial: A randomized, controlled 6-month trial to evaluate the effectiveness of the FreeStyle Libre glucose monitoring system (n=119) on glycemic control for the self-management of T1D as compared to SMBG (n=120).
II REPLACE Trial: A randomized, controlled trial to evaluate the impact of FreeStyle Libre glucose monitoring system (n=149) on HbA1c in patients with T2D taking multiple doses of insulin at 6 months compared to SMBG (n=75).
¶ FLARE Study: A real-world study of the effect of FreeStyle Libre system on 1365 T1D and T2D patients on insulin over 1 year: endpoints included A1c, hypoglycemia, and patient-reported outcomes.
References: 1. Haak, Thomas, et al. "Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-treated Type 2 Diabetes: a Multicentre, Open-label Randomised Controlled Trial." Diabetes Therapy 8, no. 1 (2017): 55-73. https://doi.org/ 10.1007/s13300-016-0223-6. 2. Bolinder, Jan, et al. "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.
3. Yaron, Marianna, et al. "Effect of flash glucose monitoring technology on glycemic control and treatment satisfaction in patients with type 2 diabetes." Diabetes Care 42, no. 7 (2019): 1178-1184. https://doi.org/10.2337/dc18-0166. 4. Evans, Mark, et al. "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. https://doi.org/10.1007/s13300-019-00720-0. 5. Kroeger, Jens, Peter Fasching, and Helene Hanaire. "Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes." Diabetes Therapy 11, no. 1 (2020): 279-291. https://doi.org/10.1007/s13300-019-00741-9. 6. Campbell, Fiona M., et al. "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. https://doi.org/10.1111/pedi.12735. 7. Dunn, Timothy C., et al. "Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycemic measures: A European analysis of over 60 million glucose tests." Diabetes Research and Clinical Practice 137 (2018): 37-46. https://doi.org/10.1016/j.diabres.2017.12.015.
8. Fokkert, Marion, et al. “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): e000809. https://doi.org/10.1136/bmjdrc-2019-000809. 9. Charleer, Sara et al. “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. doi:10.2337/dc19-1610. 10. Kao, Kalvin, et al. "Comparison of glucose metrics between users of CGM readers and CGM-connected apps." Journal of Diabetes Science and Technology (2021). https://doi.org/10.1177/19322968211044141. 11. Wright, Eugene E., et al. "Use of Flash Continuous Glucose Monitoring Is Associated With A1C Reduction in People With Type 2 Diabetes Treated With Basal Insulin or Noninsulin Therapy." Diabetes Spectrum (2021): ds200069. https://doi.org/10.2337/ds20-0069. 12. Data on File. Abbott Diabetes Care.
ADC-42746 v3.0
Important Safety Information
FreeStyle Libre 14 day, FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre systems as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose reading and alarms (if enabled) do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855‑632‑8658 or FreeStyleLibre.us for safety info.
The product images are for illustrative purposes only.
The sensor housing, FreeStyle, Libre, and related brand marks are marks of 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 prior written authorization of Abbott Laboratories, except to identify the product or services of the company.
This website and the information contained herein is intended for use by residents of the United States.
ADC-45115 v19.0
The "Yes" link below will take you out of the Abbott Laboratories family of websites. Links which take you out of Abbott Laboratories worldwide web sites are not under the control of Abbott Laboratories, and Abbott Laboratories is not responsible for the contents of any such site or any further links from such site. Abbott Laboratories is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott Laboratories.
Do you wish to leave this site?
