Important Safety Information
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COVID-19 UPDATES

USE OF FREESTYLE LIBRE 14 DAY SYSTEM IN THE HOSPITAL SETTING

Abbott’s FreeStyle® Libre 14 day system is now available for use in U.S hospitalized patients with diabetes during COVID-19 pandemic. This will permit healthcare professionals to remotely monitor patients with diabetes receiving inpatient care by assessing real-time glucose levels and glucose trends and eight hours of glucose history in real-time.

As a result, Abbott can provide the FreeStyle Libre 14 day system to hospitals who want to implement the technology for remote monitoring of glucose in patients who are able to scan the sensor themselves.

The following information should be reviewed carefully before using FreeStyle Libre 14 day systems in hospital settings.

 

Important information for hospitals using FreeStyle Libre 14 day system with hospitalized patients during the COVID-19 Pandemic

  • Hospitals should consider whether they have the resources and expertise necessary to adequately implement FreeStyle Libre 14 day system use in their facility and provide appropriate training to healthcare providers.
  • The FreeStyle Libre 14 day system should only be used in patients who are able to perform glucose scans themselves.
  • FreeStyle Libre 14 day system glucose results are less accurate than blood glucose results obtained using traditional testing methods (e.g., lab glucose, blood glucose meters) in hospital settings. Users should consider all FreeStyle Libre 14 day system glucose information (e.g. history, trends) along with individual glucose values and interpret results in the context of the full clinical picture.
  • The FreeStyle Libre 14 day sensor is subject to interferences that may generate falsely high and falsely low glucose readings. Levels of interference depend on drug concentration; substances that may not significantly interfere in non-hospitalized patients may interfere when used in the hospital setting because of higher dose levels. Most drugs used in hospital or critical care settings have not been evaluated and their interference with the FreeStyle Libre 14 day system is unknown. Known interferences include a significant positive bias due to high doses of ascorbic acid (Vitamin C) and a slight negative bias when taking salicylic acid (used in some pain relievers such as aspirin). Other reducing drugs/ compounds may also interfere.
  • Poor peripheral blood perfusion may cause inaccurate sensor readings. FreeStyle Libre 14 day system results should be interpreted considering accompanying patient conditions and medications. Other clinical conditions may also cause inaccurate readings.

 

For more information about using FreeStyle Libre 14 day system in the hospital, please contact:

Abbott Diabetes Care Hospital Sales1-800-401-1183

 

OTHER HELPFUL TIPS AND WHAT YOU SHOULD KNOW

Did you know? If you are unable to see your patients with diabetes in your office, you are able to access your patients’ FreeStyle Libre 14 day glucose reports remotely including a complete picture of their glucose patterns via LibreView*. This allows for your patients to remain safe at home while giving you the data you need to make more informed treatment decisions.

Our FreeStyle Libre digital ecosystem provides your patients with the FreeStyle LibreLink mobile app and LibreView* a secure cloud- based reporting software that allow both you and your patients to connect remotely at no cost.
Here’s how to get started

 

The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app.Use of the FreeStyle LibreLink app requires registration with LibreView, a service provided by Abbott and Newyu, Inc.

*LibreView is developed, distributed, and supported by NewYu, Inc. 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.

ADC-21076 V1.0 04/20

FreeStyle Libre, FreeStyle Libre 14 Day and FreeStyle LibreLink Indications and Important Safety Information

FreeStyle Libre and FreeStyle Libre 14 day Flash Glucose Monitoring systems are continuous glucose monitoring (CGM) devices indicated for replacing blood glucose testing and detecting trends and tracking patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments in persons (age 18 and older) with diabetes. The systems are intended for single patient use and require a prescription.

CONTRAINDICATIONS: Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment.

WARNINGS/LIMITATIONS: Do not ignore symptoms that may be due to low or high blood glucose, hypoglycemic unawareness, or dehydration. Check sensor glucose readings with a blood glucose meter when Check Blood Glucose symbol appears, when symptoms do not match system readings, or when readings are suspected to be inaccurate. The systems do not have alarms unless the sensor is scanned, and the systems contain small parts that may be dangerous if swallowed. The systems are not approved for pregnant women, persons on dialysis, or 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. The built-in blood glucose meter is not for use on dehydrated, hypotensive, in shock, hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes. When using FreeStyle LibreLink app, access to a blood glucose monitoring system is required as the app does not provide one.

Review all product information before use or contact Abbott Toll Free (855-632-8658) for detailed indications for use and safety information. For full indications for use and safety information, see more here.

FreeStyle Libre Pro Indications and Important Safety Information

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).

For full indications for use and safety information, see more here.

FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. 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 US residents only. The product images are for illustrative purposes only.

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