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The FreeStyle Libre 2 and FreeStyle Libre 3 systems are indicated for use in people with diabetes age 4 and older.
At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state. 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. 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 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 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.
^ The cited studies included participants ages 13 and older.
‡ 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.
§ 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.
‖ Glucose readings are not available during 1-hour warm-up, when sensor is too hot or too cold, when you see an error, "LO" or "HI" message, or no current glucose reading.
¶ Sensor is water-resistant in up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes.
# 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 LibreLinkUp app is only compatible with certain mobile devices and operating systems. Please check www.LibreLinkUp.com for more information about device compatibility before using the app. Use of the LibreLinkUp app requires registration with LibreView. LibreLinkUp is not intended to be used for dosing decisions. The user should follow instructions on the continuous glucose monitoring system. LibreLinkUp is not intended to replace self-monitoring practices as advised by a physician.
†† Notifications will only be received when alarms are turned on and the sensor is within 20 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 2 User’s Manual for more information.
‡‡ The FreeStyle Libre 2 app also has a mandatory Urgent Low Glucose Alarm that lets users know when their glucose value is below 55 mg/dL.
§§ To get the Urgent Low Glucose Alarm on your phone with the FreeStyle Libre 2 app, you will first need to start your FreeStyle Libre 2 sensor with your phone. If you do not start your FreeStyle Libre 2 sensor with your phone, you will not get the Urgent Low Glucose Alarm on your phone.
‖‖ The user's device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.
¶¶ Glucose alarms will transfer to the LibreLinkUp app users when users are connected and alarms are enabled on the FreeStyle Libre 2 app.
## Eligible patients will receive one (1) FreeStyle Libre 2 sensor for users with a compatible mobile phone operating system at $0 copay. The expiration date of the voucher is 60 days from the issue date. This program is available for patients with Type 1 and Type 2 diabetes; it is not available for patients with gestational diabetes. Only patients ages 18 and older are eligible to sign up and receive an offer for the FreeStyle Libre 2 sensor and patients ages 4-17 are eligible to receive an offer for the FreeStyle Libre 2 sensor through their parent or guardian. This offer is void where prohibited by law. Abbott may modify or rescind this offer at any time without notice. The discounts are not available to beneficiaries of Medicare, Medicaid or other federal or state healthcare programs or residents of Massachusetts, Puerto Rico and other US territories. The free FreeStyle Libre 2 sensor is provided as a sample and is limited to one NDC per eligible person. The FreeStyle Libre 2 sensor cannot be re-sold, traded nor submitted to any third-party payer for reimbursement and is not provided as any inducement for future purchases. The free sample card is not health insurance.
1. FreeStyle Libre 2 User’s Manual. 2. 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 (February 2017): 55-73. https://doi.org/10.1007/s13300-016-0223-6. 3. Al Hayek, Ayman A., Robert A. Asirvatham, and Mohamed A. Al Dawish. “Acceptability of the FreeStyle Libre Flash Glucose Monitoring System: The Experience of Young Patients With Type 1 Diabetes.” Clinical Medical Insights: Endocrinology and Diabetes 13 (March 2020): 1-7. https://doi.org/10.1177/1179551420910122. 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 (January 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 (January 2020): 279-291. https://doi.org/10.1007/s13300-019-00741-9.
Important Safety Information
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 https://www.FreeStyle.abbott/us-en/safety-information.html for safety info.
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