The US Food and Drug Administration has cleared Senseonics’ Eversense 365, the latest implantable continuous glucose monitoring CGM system for adults with diabetes that can last up to a year. According to the FDA, it works six months more than the previous one.

The Eversense can be inserted subcutaneously into the upper arm by a doctor in a brief procedure with a transmitter placed on the skin on top of the implanted sensor. FDA says glucose data is automatically sent every five minutes to a mobile app on the user's smartphone which can be paired. The system includes an on-body vibratory alert also as important notifications for high and low blood glucose are important.

“The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes,” said Dr. Tim Goodnow, president and chief executive officer of Senseonics, in a statement.

Eversense system requires a once-a-week measurement after the initial two weeks, making it super convenient for users. It also features a removable transmitter which you can take off when glucose data updates are not needed.

According to the FDA, the older model, Eversense E3, will remain available to certain individuals in the US.

According to studies, the safety and accuracy of the Eversense CGM System has been found to last 97 per cent of the entire year and is completely safe with only a few minor skin irritation issues reported.

Another study found that the system provided accurate glucose readings throughout its intended 90-day sensor life while maintaining a positive safety profile for patients with both type 1 and type 2 diabetes.

Experts say fingersticks should always be kept as backups

According to experts, even with a CGM device, patients should always have a backup method for measuring their blood sugar levels. Most doctors believe that all technical systems can have errors in their reporting and be impacted by heat, food, and supplements.

For non-diabetics and even those with prediabetes, fingersticks aren’t required. However, users should avoid taking CGM readings as absolute truth.

According to the developers, Eversense 365 will first be launched in the US before the end of October by marketing partner Ascensia Diabetes Care, and the patients interested in the device can pre-register on their website.

It is expected to be sold alongside the six-month Eversense E3 - cleared in 2022. Both will be indicated for adults aged 18 and older with type 1 or type 2 diabetes. The year-long lifespan contrasts with that of external CGM systems, which last just 10-15 days.

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