The continuous glucose monitoring market is dominated by companies such as Dexcom and Medtronic, to name a few, but another company recently received regulatory approval from the U.S. Food and Drug Administration, which appears to have the upper hand in terms of consumer convenience.
Germantown, Maryland-based Senseonics Holdings announced Friday that it has received FDA clearance for its next-generation Eversense E3 CGM system with a sensor life of up to six months.previous version of the device Approved in 2018 Diabetics can wear it for up to three months.
In addition to the convenience factor, the Eversense CGM fulfills a patient’s desire for an accurate, long-lasting monitor, according to the company.
“Further extending the duration of the longest-duration CGM system to six months represents a quantum leap for patients and our mission to transform the lives of the global diabetes community,” Senseonics president and CEO Tim Goodnow said in a statement. .” . “With the review delayed by a year due to Covid-19 priorities, we can now execute our launch plan with our partner Ascensia to deliver the Eversense E3 CGM System to U.S. patients starting in the second quarter.”
Eversense E3 is for people with diabetes 18 years and older. Like other CGMs, it is designed to provide better blood sugar control and eventually replace fingertip calibration. However, finger prick measurements are still required for calibration when symptoms do not match CGM information or when taking tetracyclines, the company said.
Unlike the Eversense E3 sensor, other CGMs require sensor replacement every 3 to 10 days, depending on the brand. The Dexcom G6 sensor can be worn for up to 10 days, although it Fingertip calibration is not required if used with sensor codes. Medtronic’s Enlite glucose sensor can be worn for up to 6 days at a time and its Guardian Sensor 3 can be worn for up to 7 days. Its CGM sensor does need calibration.
While the Eversense E3 sensor avoids more frequent replacements, it needs to be implanted by a qualified medical professional, whereas Medtronic and Dexcom’s sensors can be done by the user themselves. The distributor of the Eversense E3 CGM system — Ascensia Diabetes Care — is working with payers to win reimbursement for this new CGM system, which is expected to ship in the second quarter.
“Ensuring that as many people as possible have access to Eversense E3 is critical to us, and we will be launching a program to help users experience Eversense in an affordable way as we work closely with payers on coverage,” said Robert ShumPresident of Ascensia Diabetes Care, in a Monday press release.
Photo: gustavofrazao, Getty Images
