Freestyle Libre 3 By Abbott Gets FDA Clearance and Becomes the Affordable Continuous Glucose Monitor

A person riding an exercise bike while wearing the FreeStyle Libre 3 and using the phone app with Bluetooth connection to this continuous glucose monitor. © Abbott. All rights reserved. The circular shape of the sensor, housing, FreeStyle, Libre, and related brand marks are marks of Abbott.

In this fast-paced world, the dietary changes of the human population have led to the rise of diet-related diseases such as diabetes, obesity, cardiovascular diseases and more. In 2021, 537 million adults in the world are living with diabetes. With regards to the US, nearly half of its adult population is believed to have diabetes or to be in the prediabetic stage. The sharp rise in the number of people with diabetes has created awareness about managing the disease by monitoring the glucose levels with a monitor.

Conventional glucose measuring devices use a “fingersticking” procedure and are designed to have a lancing device withdraw a drop of blood, then the blood sample is applied to the test strip. The test strip is then inserted into the blood glucose monitor that displays the blood sugar level.

The newest way of glucose monitoring uses a continuous glucose monitor (CGM) which involves the insertion of a subcutaneous sensor in the belly or the arm. The CGM can then send readings directly to a smart phone, and an alarm can trigger when there is a substantial elevation or drop in glucose level.

FreeStyle Libre 3 designed by Abbott is a one-of-a-kind CGM that is one-third of the cost compared to other competing CGMs today. On Tuesday, Abbott announced that their FreeStyle Libre 3 system has received clearance by the US Food and Drug Administration (FDA).

FreeStlye Libre 3 — How Does it Work?

FreeStyle Libre 3 is a pain-free continuous glucose monitoring system. The small sensor is applied to the back of the arm and the glucose level of the interstitial fluids in the subcutaneous tissue is monitored and recorded with a reader every minute for 14 consecutive days. The monitoring of the rise or fall of glucose levels can help the diabetic individual be aware of a hyperglycemic or hypoglycemic event. It has an optional alarm that can trigger when there is a substantial increase or decrease in the glucose level.

XTALKS WEBINAR: All Means All: The Road to Inclusivity in Clinical Trials

Live and On-Demand: Tuesday, July 12, 2022, at 11am EDT (4pm BST/UK)

Register for this free webinar to learn what the FDA’s new draft guidance means for diverse and inclusive trials. The featured speakers will discuss the new draft guidance and its shortcomings and what the industry still needs to address to make clinical trials more inclusive for all.

Highlights of the FreeStyle Libre 3

FreeStyle Libre 3 has an easy-to-use, one-piece applicator which makes it straight-forward to apply the sensor on the skin. The sensor is the size of two stacked US pennies, and it is the smallest and thinnest sensor among the currently available CGM sensors all over the globe.

The accuracy of a CGM is determined by its mean absolute relative difference (MARD), which is calculated by comparing the glucose levels in the interstitial fluid in the subcutaneous tissue detected by the CGM and the blood glucose level in capillary blood. The MARD value is expressed as a percentage and a good CGM should have a MARD less than 10 percent. FreeStyle Libre 3 has been determined to have a 7.9 percent overall MARD, making it the first CGM to have a MARD less than eight percent.

FreeStyle Libre 3 is the size of two stacked US pennies, and it is the smallest and thinnest sensor among the currently available continuous glucose monitors in the world. © Abbott. All rights reserved. The circular shape of the sensor, housing, FreeStyle, Libre, and related brand marks are marks of Abbott.

In this digital revolution era, every individual needs their gadget to be paired with their mobile phone. FreeStyle Libre 3 holds a strong Bluetooth integration which can be detected even at 33 feet away.

“The FreeStyle Libre 3 system is a direct result of listening to our customers — and giving them the innovation and sensing technology they’ve been looking for,” said Jared Watkin, senior vice president of Abbott’s diabetes care business in the company’s press release. “It’s a game changer for the millions of people living with diabetes. They’ll be able to manage their health minute-by-minute with the world’s smallest and thinnest sensor and most accurate 14-day continuous glucose monitoring system.”

Affordability of FreeStyle Libre 3

The price of CGM systems may become a financial burden in a diabetic person’s life as it varies according to the insurance plan of the individual. The out-of-pocket price without insurance for CGM systems supplies can vary between $160 per month to $500 per month. The cost of FreeStyle Libre 3 is same as its predecessors, and it is one-third of the price of competing CGMs that are currently available.           

Abbott’s CGMs

Abbott has an extensive diabetes care research group, and they had their first CGM, the FreeStyle Libre system, approved by the FDA in September 2016. Their subsequent CGM, FreeStyle Libre 2, got the FDA nod by June 2020.