ABBOTT PARK, Ill. – It was just a few months ago that the U.S. Food and Drug Administration approved Abbott Diabetes Care’s FreeStyle Libre Flash Glucose Monitoring System for public use in the U.S., making it the first FDA-approved CGM not to require a fingerstick test or manual data entry for calibration. That means that the device is so accurate, people managing Type 1 or Type 2 diabetes can dose insulin off of it.
Today, Abbott announced that the new, factory-calibrated technology is now available to Medicare patients since its approval by the U.S. Centers for Medicare & Medicaid Services (CMS). It will be the only CGM system available to Medicare patients that doesn’t require calibration.
“At Abbott, we are continuously challenging ourselves to ensure our innovative technology is accessible to the majority of people who need it,” said Jared Watkin, Sr. VP at Diabetes Care. “This revolutionary health technology […] is ultimately going to empower Medicare beneficiaries with diabetes to live better, healthier lives.”
FreeStyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days, making it the longest lasting personal glucose sensor available in the U.S.
The FreeStyle Libre 14 day system is a continuous glucose monitoring (CGM) system consisting of a smartphone app‡or a handheld reader and a glucose sensor worn on the back of the upper arm. How does it work? The sensor uses a thin, flexible filament inserted just under the skin tomeasure glucose levels every minute. How do you use it? The FreeStyle Libre comprises a monitor that sticks to your upper rear arm and stays there for two weeks, as well as a unit to take the measurement, or just use your phone's contactless to scan. There is also an add-on called MiaoMiao which attaches to the sensor and feeds data directly to your phone live making it a Constant Glucose Monitor (CGM).
The FreeStyle Libre 2 System. The FreeStyle Libre system 2 eliminates the need for painful routine finger pricks † offering an easy way to check glucose with a painless 1 1-second scan even through clothing Ω. Now with optional alarms to let you know when your glucose is too high or too low. The small, discreet sensor worn on the back of. Add to Wishlist. The FreeStyle LibreLink app allows you to monitor your glucose with your phone. 1 Check your glucose by holding your phone near your FreeStyle Libre Sensor. The App is compatible with both 10-day and 14-day Sensors. You can use the App to:. Check your glucose with a painless scan, instead of a routine fingerstick 1. Using the Built-in Meter The Reader has a built-in meter that can be used to test your blood glucose and blood ketone or to test the meter and strips with control solution. WARNING: Do NOT use the built-in meter while the Reader is connected to an electrical outlet or a computer.
Other features include water-resistance and an ability to obtain a reading without the interference of acetaminophen, an active ingredient in many over-the-counter medications, which can inaccurately report dangerously high blood glucose levels.
The FreeStyle Libre also is a system with only two parts: sensor and reader, as opposed to having the the additional transmitter.
Medicare patients can access the FreeStyle Libre system with a prescription through the following suppliers: Edgepark Medical Supplies, Byram Healthcare, Solara Medical Supplies, Edwards Health Care Services, Better Living Now and Mini Pharmacy in the U.S.
Not a Medicare patient? You can purchase the system without insurance coverage via any of the following major U.S. retail pharmacies: CVS, Walgreens, RiteAid, Walmart and Kroger.
George Grunberger, M.D., chairman, Grunberger Diabetes Institute commented, “The accessibility and affordability of this CGM technology is unprecedented, and this is a huge step forward for the diabetes community — both Type 1 and Type 2.”
INDICATIONS AND IMPORTANT SAFETY INFORMATION
The FreeStyle Libre Flash Glucose Monitoring system is a continuous glucose monitoring (CGM) device 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 system is intended for single patient use and requires 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 FreeStyle Libre system does not have alarms unless the sensor is scanned, and the system contains small parts that may be dangerous if swallowed. The FreeStyle Libre system is 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. Review all product information before use or contact Abbott Toll Free (855-632-8658) or visit www.freestylelibre.us for detailed indications for use and safety information.
Keep blood glucose control tight with automatic blood sugar updates every five minutes sent straight to your mobile device.
The bubble has been built with comfort in mind, avoiding edges that can complicate its wearing in your day to day and to keep charging simple.
With our signature Bubble stickers, the soft specially designed belt, or even a simple dressing, you will have plenty of options available to find the best fit for you and your Bubble.
How Is Freestyle Libre Installed
The bubble is rechargeable thanks to the magnetic charger included in the box. With over 20 days or more of battery, you can always be sure your Bubble is charged and ready to go.
A compact tightly sealed frame improves durability and makes the Bubble waterproof. The device is guaranteed up to 30 minutes and 2m deep in fresh water.
Parents of a toddler using the FreeStyle Libre sensor can use Bubble to view glucose readings in the Diabox app.
Users can see glucose reading updates every 5 minutes on Android, iPhone, and smartwatch (Apple and Android), and they can receive notifications and alarms on their watch or phone.
The bubble can be used with both iOS or Android. Check the available apps for each software platform.
The bubble works with the following types of
FreeStyle Libre 1 sensors,
works with FreeStyle Libre US 14-day sensor available in the US,
FreeStyle Libre 2 Germany, Norway, France, United Kingdom, EU
FreeStyle Libre Pro in the US and a few countries in Asia, and FreeStyle Libre sensors.
note that LIBRE 2 USA is not currently available on AppStore and not in Diabox app yet.