This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Freestyle Libre Flash Glucose Monitoring System

PMA Applicant: Abbott Diabetes Care Inc.

Address: 1360 South Loop Road, Alameda, CA, 94502

Approval Date: July 23, 2018

Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160030S017a.pdf

What is it? The Freestyle Libre 14 Day Flash Glucose Monitoring System (Freestyle Libre) is a glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without obtaining a blood sample from the fingertip (fingerstick). The system consists of an externally-worn glucose sensor that continuously measures glucose levels and displays values to the user in response to a user-initiated action (scan). This supplement updates the FreeStyle Libre's approval to provide on-demand glucose information to a user for up to fourteen days (the life of each sensor). The system does not passively monitor glucose levels or provide messages, alarms or alerts in the absence of user-intiated action.

How does it work? The patient uses the sensor applicator to apply the sensor to the back of their upper arm. The sensor has a small flexible metal wire that goes just below the skin where it generates a small electrical signal in response to the amount of sugar that is present in fluid under the skin (interstitial glucose). This electrical signal is converted into a blood glucose reading, and is transmitted to a dedicated, mobile device (reader) when a user scans the reader a short distance above the sensor. The system does not require calibration with fingertip blood samples using a blood glucose meter.

When is it used? The FreeStyle Libre Flash Glucose Monitoring System is indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing with a fingerstick for diabetes treatment decisions. The FreeStyle Libre detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia (too high glucose) and hypoglycemia (too low glucose), to help patients make acute and long-term therapy adjustments. Interpretation of the FreeStyle Libre readings should be based on the glucose trends and several sequential readings over time. The System is intended for single patient use and requires a prescription.

What will it accomplish? People with diabetes can use the information from this device to make diabetes treatment decisions (for example, whether to administer insulin or carbohydrates). Information from the device can also be used to help determine patterns in glucose levels and make long-term adjustments to diabetes treatment plans to keep blood glucose levels in a safe range.

When should it not be used?

The FreeStyle Libre Flash Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The effect of MRI, CT scans, or diathermy on the performance of the FreeStyle Libre has not been evaluated. The exposure may damage the sensor and may impact proper function of the device which could cause incorrect readings.

The FreeStyle Libre system is not approved for pregnant women, persons on dialysis, or critically-ill population.

The built-in blood glucose meter is not for use on patients who are dehydrated, hypotensive, in shock, in a hyperglycemic-hyperosmolar state, with or without ketosis, neonates, critically-ill patients, or for diagnosis or screening of diabetes.

Additional information (including warnings, precautions, and adverse events): The Freestyle Libre Flash Glucose Monitoring System is only approved for the management of diabetes in persons age 18 years and older. Summary of Safety and Effectiveness Data and labeling are available online.