The implantable sensor that is currently part of Senseonics’ Eversense continuous glucose monitor (CGM) system is FDA-approved for 90 days of use. Now, the company has begun trials to seek FDA approval for an implantable sensor that would last twice as long.
Senseonics announced this month that it has begun clinical trials to prove the sensor is safe and effective for 180 days of continuous use, with the goal of gaining FDA approval for the longer-life CGM system. The trial is expected to enroll about 180 participants in about 15 locations.
The Eversense XL already has the European Union’s CE mark of approval. The system includes a wearable transmitter that sends readings to a mobile app.
In the same announcement, Senseonics shared news that it is also seeking FDA approval to be able to say that readings from the currently approved Eversense CGM can be used to make blood sugar management treatment decisions. While many people with type 1 diabetes have long used CGM readings to make dosing decisions without checking with a fingerstick, only recently have Dexcom and Abbott gained FDA approval to officially market some CGMs as accurate enough for dosing decisions.
Senseonics also said in the same announcement that it is asking the FDA to remove a contraindication for MRI use with the implantable sensor currently available on the U.S. market.
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