Senseonics' FDA-cleared CGM has a sensor that lasts six months, a first for any CGM. Other competing solutions from Medtronic and Dexcom last between three and 10 days.
The continuous glucose monitoring market is dominated by companies like Dexcom and Medtronic, to name a few, but another company recently received an approval from the Food and Drug Administration that appears to be upping the game in terms of consumer convenience.
Germantown, Maryland-based Senseonics Holdings announced Friday that its next-generation Eversense E3 CGM system, which has a sensor life of six months, has been cleared by the FDA. An earlier version of the device, approved in 2018, could be used by diabetes patients for up to three months.
In addition to the comfort factor, Eversense CGM also satisfies the patient's desire for an accurate and durable monitor, according to the company.
"Further extending the life of the longest-lasting CGM system to six months represents a tremendous advance for patients and advances our mission to transform life in the global diabetes community," said Tim Goodnow, President and CEO of Senseonics. , it's a statement. statement. "The review was delayed a year due to COVID-19 priorities and now, together with our partner Ascensia, we are able to execute on our launch plan to ship the Eversense E3 CGM System to US patients starting the second trimester".
Eversense E3 is suitable for people over the age of 18 with diabetes. Like other CGMs, it is intended to provide better glycemic control and ultimately replace fingerstick calibration. However, fingerstick measurements are still required for calibration when symptoms do not match CGM information or when taking drugs from the tetracycline class, the company said.
Unlike the Eversense E3 sensor, other CGMs require sensor replacement every three to ten days, depending on the brand. A Dexcom G6 sensor can be used for up to 10 days, but does not require fingerstick calibration when used with a sensor code. The Medtronic Enlite glucose sensor can be worn for up to six days at a time and the Guardian Sensor 3 can be worn for up to seven days. The CGM sensors need to be calibrated.
While the Eversense E3 sensor avoids more frequent replacements, it must be implanted by a qualified medical professional, while those from Medtronic and Dexcom can be done by users themselves. The distributor of the Eversense E3 CGM system, Ascensia Diabetes Care, is working with payers to obtain reimbursement for this new CGM system and expects to ship the product in the second quarter.
"Ensuring that as many people as possible have access to Eversense E3 is critical to us, and we will launch a program that allows users to experience Eversense at affordable prices while working closely with payers on coverage," said Robert Schumm, President of Ascensia Diabetes Care, in a press release on Monday.