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FDA Approves Longest Lasting Continuous Glucose Monitor for Diabetes | by heidi


 

The U.S. Food and Drug Administration (FDA), in February 2022, approved a new continuous glucose monitor (CGM) for diabetes with a sensor that can last for up to six months. Known as the Eversense E3 System, the device is now the longest lasting CGM approved in the United States and the world. It is expected to be available for adult patients this spring 2022.1



Previously, the longest approved sensor lasted for 90 days. This was also an Eversense product, and was approved in 2018.2


What is a CGM?

CGMs track blood sugar levels and trends in people with type 1 and type 2 diabetes to help people make informed decisions about their diet and lifestyle. Monitors track this information 24/7 (hint: continuous) and many provide updates to their wearer every five minutes.


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“Further extending the duration of the longest lasting CGM system to six months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics, said in a press release.1



Goodnow added that the product’s review was delayed a year due to the pandemic, and that the current launch will help establish a foundation for growth.



How Long Do Most CGM Sensors Last?

Depending on what brand a person has, a CGM sensor can be changed at home or in a doctor's office. A sensor that can be changed at home will typically last between one and two weeks. Devices that require a doctor’s visit for changing may only need to be changed a handful of times a year, according to the Cleveland Clinic.3



Changing out the sensors in an Eversense E3 requires a procedure, so a patient should schedule a doctor's appointment when their six months are up.


How Does The Eversense E3 Work?


In addition to the CGM sensor, which rests under the skin and requires a procedure to put in and take out, the Eversense E3 contains a removable smart transmitter, which is attached to the body with silicon adhesive. While the sensor collects data, the transmitter interprets it and displays it to the wearer. It does this by providing vibrations and smartphone alerts with sugar levels and trends.


CGMs are more helpful for people with type 1 diabetes, who cannot make insulin on their own and need frequent data on their levels in order to know how many insulin injections, or pumps, to give themselves, according to Kaiser Health News. They are less helpful—and perhaps needlessly expensive—for people with type 2 diabetes, who can make insulin on their own and respond less severely to level changes than people with type 1.4


People who use CGMs do not have to prick their finger before each reading, but may still need to administer a prick once or twice a day to calibrate the device.


Is It Affordable?


CGMs are generally expensive, especially for people paying out of pocket, and costs can reach thousands of dollars a year. Still, several private insurance companies and Medicare will cover CGM for some patients.


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People who pay out-of-pocket for an Eversense E3 may be eligible for financial assistance through Ascensia Diabetes Care (ADC), which will pay up to $300 of the balance of costs, or up to $1,200 a year. Medicare may cover Eversense E3 for people with diabetes, who take insulin at least three times a day (or use an insulin pump), test their blood glucose at least four times daily, and have a doctor’s appointment every six months.


Prior to its approval, the device was studied for its accuracy and safety in a study called the PROMISE study, which found the device to be accurate and safe for up to 180 days and an improvement from past options.5


“We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” Satish Garg, MD, principal investigator of the study said in the press release. “This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.”


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