The FreeStyle Libre 2 system and its suite of digital health tools offer a seamless diabetes management experience. With this CGM system, patients experienced fewer complications and reduced resource utilization.*4
CGM = continuous glucose monitoring
The FreeStyle Libre 2 app¶ makes patient data easily# accessible
to the patient's entire care team.** By scanning the sensor with
their smartphoneǁ instead of the reader,†† patients receive insights
and reports with glucose patterns and trends all in one place.
Patients can get real-time glucose readings5 and feedback on
glucose levels and trends to make informed diabetes
management decisions.
With the FreeStyle Libre 2 system, your patient’s sensor measures glucose every minute5 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.*7
No confirmatory fingersticks## required for insulin dosing—even when glucose is low, falling, or rapidly changing.5
Medicare coverage is available for the FreeStyle Libre 2 system if a compatible smartphone is used in conjunction with the FreeStyle Libre 2 reader to review glucose data. Medicare coverage and other third party payor criteria apply. As a courtesy, Abbott provides the most up-to-date information available, but 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 of 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.
† 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.
§ Based on a comparison to Dexcom G6.
ǁ Glucose readings are not available during 1-hour warm-up, when sensor is too hot or too cold, or when you see an error, "LO" or "HI" message, or no current glucose reading.
¶ 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.
# In comparison to the FreeStyle Libre 2 reader.
** The user must be connected to data services for glucose data to automatically upload to 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 LibreLinkUp app is only compatible with certain mobile device 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.
§§ The user's device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.
ǁǁ 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.
¶¶ Glucose alarms will transfer to the LibreLinkUp app users when users are connected and alarms are enabled on the FreeStyle Libre 2 app.
## 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.
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 (February 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 (November 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 (September 2016): 2254-2263. https://doi.org/10.1016/S0140-6736(16)31535-5. 4. Deshmukh, Harshal, et al. "Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit." Diabetes Care 43 (September 2020): 2153-2160. https://doi.org/10.2337/dc20-0738. 5. FreeStyle Libre 2 User's Manual. 6. Data on File. Abbott Diabetes Care. 7. Unger, Jeff, Pamela Kushner, and John E. Anderson. "Practical guidance for using the FreeStyle Libre flash continuous glucose monitoring in primary care." Postgraduate Medicine 132, no 4. (March 2020): 305-313. https://doi.org/10.1080/00325481.2020.1744393.
ADC-42702 Ver 1.0 09/21
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 v5.0 05/22
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