In this study, a libre was approved for patients by the US Food and Drug Administration in September 2017, comprises a sensor worn on the upper arm for 10 days and a reader that the patient uses to scan the sensor to obtain a glucose value. The reader also displays glucose trends and values for the past 8 hours. The Abbott FreeStyle Libre Glucose Monitoring System will now be covered under Medicare in the United States for beneficiaries with diabetes (either type) who are on intensive insulin regimens
Unlike continuous glucose monitors (CGMs) made by Dexcom and Medtronic, the Libre does not sound alarms to warn the patient of low or high glucose values and does not allow for glucose data to be remotely shared in real-time, as the Dexcom does. The coverage decision by the Centers for Medicare and Medicaid Services was based on the FDA's licensing of the Libre for "nonadjunctive" use.
This means that patients can use the glucose values reported by the device to calculate insulin doses without the need for a confirmatory fingerstick glucose measurement. That designation also applies to the Dexcom G5 CGM, which is now also covered under Medicare.But unlike the G5, the Libre is factory-calibrated so fingersticks aren't required for calibration either, whereas both the Dexcom and Medtronic CGMs must be calibrated twice a day.
For Medicare patients, the Libre system is available by prescription in the United States through Edgepark Medical Supplies, Byram Healthcare, Solara Medical Supplies, Edwards Health Care Services, Better Living Now, and Mini Pharmacy. Abbott records about non-Medicare patients, the Libre system is also available at major US retail pharmacies (CVS, Walgreens, RiteAid, Walmart, and Kroger), "removing the barrier of complicated paperwork necessary for commercial insurance coverage and making it more readily accessible to patients."
It enhances that the FreeStyle Libre system is now being used by over 400,000 people across more than 40 countries, and notes that partial or full reimbursement for the system has been protected in 21 countries, including France, Japan, the United Kingdom, and now the United States.