Pharma To Date

The FDA has granted approval to Senseonics’ Eversense 365, marking a significant advancement in continuous glucose monitoring (CGM) technology. This latest iteration of the Eversense system is distinguished by its impressive 365-day sensor lifespan, representing a major leap forward from the previously available 90-day and 180-day versions.

The Eversense 365 system, developed in collaboration with Ascensia Diabetes Care, includes a sensor about the size of a grain of rice implanted under the skin. This sensor continuously measures blood glucose levels and transmits data to a wearable transmitter. The extended duration of the sensor reduces the frequency of device replacements, which can be particularly beneficial for patients managing Type 1 or Type 2 diabetes.

This innovation offers multiple advantages. Firstly, the 365-day sensor significantly lessens the burden of frequent sensor changes, a common inconvenience with shorter-duration devices. After insertion, the Eversense 365 requires only a single “Day 1” calibration, streamlining the user experience compared to other systems that necessitate multiple calibrations over their lifespan. Additionally, the transmitter’s silicone-based adhesive can be replaced daily without affecting the sensor's placement.

The FDA's approval of the Eversense 365 as an integrated CGM system is noteworthy because it allows the device to connect seamlessly with compatible insulin pumps and other diabetes management tools. This integration has the potential to enhance automated insulin delivery systems, making diabetes management more effective and less intrusive for patients.

Ascensia plans to commence the commercial launch of the Eversense 365 in the fourth quarter of this year, while also working on securing reimbursement coverage. The ongoing discussions with insulin pump manufacturers aim to maximize the system's utility by integrating it with existing diabetes care technologies.

Overall, the approval of the Eversense 365 underscores a significant advancement in diabetes care technology, providing a more convenient and efficient option for continuous glucose monitoring. This development is expected to improve patient adherence to monitoring protocols and potentially enhance overall diabetes management outcomes.