On Monday, Abbott Laboratories, an Illinois-based multinational medical devices company, said the FDA has approved its much anticipated integrated continuous glucose monitoring system called FreeStyle Libre 2 for adults and children above 4 with diabetes.
The system continuously transmits glucose data every minute and users can set it to send alarms to monitor their glucose.
The product works when users apply a small sensor on the back of their upper arm. The system will then monitor the glucose levels. The wearable can last for up to 14 days.
FreeStyle Libre 2 will be able to transmit data to a handheld device so users can view their glucose readings and trends, which can be used with a smartphone device.
According to the MedTech device company, the product will be rolled out at pharmacies across the United States within the next coming weeks.
Senior Vice President for Diabetes Care at Abbott Jared Watkin said, “Managing diabetes is expensive, even for those with insurance coverage.”
“From the start, Abbott designed FreeStyle Libre technology with affordability in mind,” he added. “We set a global price for our sensing technology that’s closer to that of traditional blood glucose fingerstick systems, and significantly less than other CGMs because we wanted to make sure our life-changing technology was accessible to as many people as possible.”
In 2017, the FDA granted approval of the FreeStyle Libre system for use without fingersticks. At the time, it was cleared for 10-day use. However, in 2018, Abbott received another approval for its FreeStyle Libre 14 Day Flash Glucose Monitoring System.
Last week, a study, published in U.S. Endocrinology, found that Abbott’s FreeStyle Libre demonstrated significant cost savings for patients with diabetes compared to traditional fingerstick testing.
Apart from Abbott, Dexcom and Medtronic are among the other big names in the CGM industry.
Recently, rival company Dexcom announced that its G6 Pro would begin shipping in July, which is a system that allows for blinded and unblinded modes of use. It can read glucose values up to every five minutes. Just like the FreeStyle Libre 2, G6 Pro has been approved for continuous glucose monitoring without the need for fingerstick calibrations.