FreeStyle Libre CGM systems make it easy to support better outcomes by enabling greater glucose control*1–3
CGM = continuous glucose monitor(ing)
Both real-world evidence and clinical trial results highlight the benefits of FreeStyle Libre CGM systems*1–9
A1C = hemoglobin A1C; BGM = blood glucose monitoring; T1D = Type 1 diabetes; T2D = Type 2 diabetes; TIR = time in range
FreeStyle Libre 3 system is cleared to be used by children 4 years and older with Libre 3 sensor and 2 years and older with Libre 3 Plus sensor.
FreeStyle Libre 2 system is cleared to be used by children 4 years and older with Libre 2 sensor and 2 years and older with Libre 2 Plus sensor.
Medicare and other payor criteria may apply. Abbott provides this information as a courtesy and does not guarantee payment or coverage.
* Study was performed with the outside US version of the FreeStyle Libre 14 day system. Data is applicable to FreeStyle Libre 2 and 3 systems, as feature sets are similar as FreeStyle Libre 14 day system, excluding alarms.
† The FreeStyle Libre systems apps are only compatible with certain mobile devices and operating systems. Please check the Support section of our website for more information about device compatibility before using the apps. Use of the FreeStyle Libre systems apps may require registration with LibreView.
‡ 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.
§ Study was performed with the US version of the FreeStyle Libre 14 day system. Data is applicable to FreeStyle Libre 2 and 3 systems, as feature sets are similar as FreeStyle Libre 14 day system, excluding alarms.
II 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 BGM (n=120).
¶ 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 BGM (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. https://doi.org/10.1016/S0140-6736(16)31535-5. 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. Kröger, Jens, Peter Fasching, and Hélène 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. https://doi.org/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 16, no. 1 (2021): 259-260. 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 34, no. 2 (2021): 184-189. ds200069. https://doi.org/10.2337/ds20-0069. 12. Data on file. Abbott Diabetes Care, Inc.
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Important Safety Information
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. Get medical attention when appropriate. Abbott Customer Service: 855-632-8658 or visit FreeStyleLibre.us for safety info.
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