Senseonics implantable CGM pivotal meets interim endpoint

Senseonics said today a clinical study of its implantable, long-term continuous glucose monitoring system met its interim phase primary effectiveness and safety endpoints.

Senseonics is developing micro-sized sensors and connected smartphone apps for glucose monitoring. The device is inserted into a patients upper arm, just below the skin, and can connect wirelessly to a smartphone application, the company said.

“The promising interim results from the Precise study, as well as the subsequent submission of our CE mark application, are major milestones for the company. When it receives clearance, our 90-day CGM system will be the longest-lasting glucose sensor that is safe and accurate for people with diabetes to use,” CEO Tim Goodnow said in a press release.

Data from 44-patients in the Precise study reported “strong accuracy throughout the first 90-days, with a mean absolute relative difference of 11.4% in the 75 to 400 mg/dL range when compared to YSI blood reference values.

The study reported that 84% of sensor value were within 20% of the YSI reference, and there were no significant adverse events related to use of the system.

“Overall our patients were very satisfied with the device and regretted that they couldn’t continue using it after the trial,” lead investigator Dr. J. DeVries of the University of Amsterdam said in a press release.

Subjects in the study underwent sensor insertions on the 1st day and used the transmitter and mobile app at home over the next 90, Senseonics said.

Senseonics said it has submitted a design dossier to obtain CE Mark approval in the European Union for the system, and plans to launch the product in Scandinavia 1st, followed by other European countries once it wins the CE Mark.

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