Senseonics has enrolled its first U.S. patient in a clinical trial for its 180-day extended-wear continuous glucose monitoring sensor as part of a premarket application submission to the FDA, according to a press release from the company.
The PROMISE study is designed to evaluate the safety and efficacy of the Eversense CGM system in people with diabetes and will include approximately 180 participants at up to 15 sites, according to the company. The Eversense XL sensor received a CE mark and is available in the European Union.
The Eversense CGM consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. As Endocrine Today previously reported, the FDA approved the Eversense system with a 90-day sensor in June.
Additionally, Senseonics also completed its submission of PMA supplements to the FDA to secure an insulin dosing claim and to remove the contraindication related to MRI exposure on the 90-day system currently available in the U.S., according to the release.
“We are pleased to have enrolled the first participant in this important study, which demonstrates our continued progress in transforming CGM technology,” Tim Goodnow, president and CEO of Senseonics, said in the release. “This is the first study in the U.S. in which participants are implanted with a single sensor designed to produce accurate continuous glucose measurements for half of a year. Our submission of the supplements to secure the dosing claim and to remove the MRI contraindication for the current 90-day Eversense system [is a] significant step forward in reducing the burden of diabetes management and providing patients peace of mind.”
The small, subcutaneous sensor is implanted in the upper arm by a health care provider during an outpatient procedure, and then measures glucose levels for up to 90 days. The sensor utilizes light-based technology to measure glucose levels and send information to the app to alert users of hypoglycemia and hyperglycemia. Measurements are sent every 5 minutes to a compatible mobile device via the app. The smart transmitter provides on-body vibratory alerts for discretion and safety. This is the only CGM transmitter that can be removed and recharged without discarding the sensor, according to the company. – by Regina Schaffer