The FreeStyle Libre portfolio of products offers a seamless diabetes management experience. With these CGM systems, patients experience fewer complications and reduced resource utilization*†1-3,5-9.
The FreeStyle Libre portfolio of products offers a seamless diabetes management experience. With these CGM systems, patients experience fewer complications and reduced resource utilization*†1-3,5-9.
CGM = continuous glucose monitoring
With the FreeStyle Libre CGM systems, your patient’s sensor measures glucose every minute12-14 so they can dose insulin or treat for lows. And instead of time-consuming interpretations of blood glucose logs, sensor data quickly identifies glycemic patterns and trends¶¶11.
No confirmatory fingersticks##***required for insulin dosing—even when glucose is low, falling, or rapidly changing12-14.
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 the FreeStyle Libre 2 system if the FreeStyle Libre 2 reader is used to review glucose data on some days every month. Medicare and other third party payor criteria apply.
At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state.
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.
‡ Compared to self-monitoring blood glucose testing.
§ Sensor is water-resistant in up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes.
II The FreeStyle Libre 3 app is designed to facilitate data sharing between patients and their healthcare providers and caregivers.
¶ The user must be connected to data services for glucose data to automatically upload to LibreView.
# The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app. Use of the FreeStyle Libre 3 app requires registration with LibreView.
** In comparison to the FreeStyle Libre 2 reader.
†† The FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app. Use of the FreeStyle Libre 2 app requires registration with LibreView.
‡‡ The FreeStyle Libre 2 app and the FreeStyle Libre 2 reader have similar but not identical features. Fingersticks are required for treatment decisions when you see the Check Blood Glucose symbol and when your glucose alarms and readings from the system do not match symptoms or expectations.
§§ 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.
IIII LibreView is ISO27001/27018/27701 certified and HITRUST CSF Certified.
¶¶ Data from this study was collected with the 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.
## FreeStyle Libre 2 and 3 systems: 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.
*** 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.
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. 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. 3. Bolinder, Jan, et al. "Novel Glucose-sensing Technology and Hypoglycaemia in Type 1 Diabetes: a Multicentre, Non-masked, Randomised Controlled Trial." The Lancet 10057, no. 388 (2016): 2254-2263. https://doi.org/10.1016/S0140-6736(16)31535-5. 4. 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. 5. 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. 6. Kroger, Jens, et al. "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): 271-291. https://doi.org/10.1007/s13300-019-00741-9. 7. Dunn, Timothy C., et al. “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. 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. Data on File. Abbott Diabetes Care. 11. Unger, Jeff, et al. "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. 12. FreeStyle Libre 14 day User's Manual. 13. FreeStyle Libre 2 User's Manual. 14. FreeStyle Libre 3 User's Manual. 15. Dexcom G6 CGM User Guide and Medtronic Guardian Connect System User Guide.
ADC-42702 v2.0 11/22
Important Safety Information
FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system 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 readings 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.
FreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre 2 or FreeStyle Libre 3 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 alarms and readings 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.
FreeStyle Libre Pro: The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription.
IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use.
CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment.
WARNINGS/LIMITATIONS: The FreeStyle Libre Pro System does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss may experience inaccurate results with this system. The FreeStyle Libre Pro System is not approved for pregnant women, persons on dialysis, or recommended for 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. Review all product information before use or contact Abbott Toll Free (855-632-5297) (or visit provider.myfreestyle.com) for detailed indications for use and safety information.
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ADC-45115 v11.0 02/23
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