Though the review of its six-month implantable glucose sensor has faced delays at the FDA during the COVID-19 pandemic, Senseonics was able to deliver clinical data on its accuracy at two diabetes meetings this month.
The company’s study showed its performance was able to match its current 90-day sensor among users with Type 1 and Type 2 diabetes, while only needing to be calibrated once per day with fingerstick blood draws, instead of twice with the previous model.
When lined up against glucose readings from a traditional blood sugar meter, the Eversense 180-day primary sensor deviated in its measurements 9.1% of the time on average among 49,000 comparisons captured across the study, which first began in December 2018.
In addition, the sensor was able to spot moments of dangerously low blood sugar, warning the user of hypoglycemia when levels dipped below 70 mg/dL 93% of the time and below 60 mg/dL 87% of the time.
The Eversense system includes a fluorescence-based sensor, about the size of a grain of rice, which a healthcare professional embeds under the skin of the upper arm. A digital reader and transmitter worn on top vibrates to deliver alerts for high and low glucose readings. The device also connects to a smartphone app and can be removed, recharged and replaced without having to change the implanted sensor.
A secondary sensor—employing a different chemistry and used by fewer participants—was also tested in the study. It demonstrated an average difference rate of 8.5%, and triggered hypoglycemia alerts of 94% and 90% of the time for drops below 70 mg/dL and 60 mg/dL, respectively.
“As we await hearing from the U.S. and European regulatory agencies concerning our pre-market submissions of data from both the primary and [secondary] sensors, we are pleased to continue to offer the Eversense CGM systems in both the U.S. and Europe with our commercialization partner, Ascensia Diabetes Care,” Senseonics’ president and CEO, Tim Goodnow said in a statement earlier this month, after results were presented at the International Conference on Advanced Technologies and Treatments of Diabetes. Study data were also delivered at this week’s annual meeting of the American Diabetes Association.
The FDA first approved Senseonics’ 90-day Eversense sensor in June 2018, but the new version, which aims to double its lifespan, has been held up at the agency since last year, as staff have faced a deluge of product applications and emergency use requests from companies hoping to respond to the COVID-19 pandemic.
Last December, Senseonics said it was told to expect review delays of at least two months and that the company was planning to push the sensor’s pending commercial rollouts to the middle of this year or later.
Roche previously served as the Eversense system’s exclusive distributor in Europe, the Middle East and Africa and later added new markets in the Asia-Pacific, South American and Latin American regions. This past January, though, the company passed the torch to Ascensia after Senseonics inked an $80 million financing deal with international distribution rights lasting through 2025.