Germantown, Md.-based Senseonics Inc. said results from a recent study confirm that the sensor in its Eversense continuous glucose monitoring (CGM) system performs well over multiple, sequential 90-day and 180-day cycles. The Eversense system is currently the only long-term implantable CGM for people living with diabetes.

The real-world trial, which was funded by Senseonics, assessed the accuracy of the Eversense data management system by comparing sensor blood sugar values with self-monitored glucose values in 945 adult Eversense users in Europe and Africa who had cycled through at least four sensor insertions and replacements. The study was conducted in the home setting between June 2016 and August 2019.

Among the nearly 1,000 Eversense users, the time in target glucose range – between 70-180 mg/dL – was 63% to 64%, demonstrating soundness across multiple sensor wear cycles. Glycemic control also was maintained. The estimated A1c, a measure of average blood glucose over the past three months, was 7.0-7.1 over four sensor cycles.

On patient adherence, the study found 83.2% to 85.8% median wear time across all four sensor cycles, demonstrating willingness of patients to use the device as directed over multi-cycle wear periods, including nearly 1,300 patient years of real-world follow-up.

“This report demonstrates that the accuracy and CGM metrics with the Eversense CGM System are stable over multiple sensor insertion and removal cycles in real-world use,” the authors wrote. “No degradation of performance from the insertion and removal procedures and resultant tissue response to the sensor was observed.” The results were first published online Nov. 7, 2019, in the journal Diabetes Technology and Therapeutics.

‘Great validation’

“It’s great validation for us that a long-term, implanted sensor that replaces the patient having to do this themselves every seven, 10 or 14 days, depending on which sensor you use, that you get the same … function as you do with those other sensors,” Francine Kaufman, chief medical officer at Senseonics, told BioWorld MedTech.

Senseonics won U.S. FDA approval for Eversense for up to 90 days of use in June 2018. In June, the agency added a nonadjunctive indication, meaning the device can be used to make treatment decisions without a confirmatory fingerprick blood sugar test. However, users must still do twice daily fingerprick tests for calibration purposes.

Kaufman said the company did the study to show that its long-term sensors are comparable to, if not better than, other CGMs in the market. “With the nonadjunctive claim, now we’ve got that accuracy that’s been quite good, our MARD [mean absolute relative difference] is actually better than what’s been described in other sensors, [and] we’ve got the clinical outcomes that we can show in almost a thousand patients over time,” she said. “So, I think we’re really building the right kind of evidence.”

The positive results are a feather in the cap for Senseonics, which saw third-quarter revenues down 17% year over year to $4.3 million. Of that amount, only about $500,000 stemmed from U.S. sales, and most of those related to the Eversense Bridge Program, a patient access program that assists people with out-of-pocket costs for the Eversense CGM. The bulk of the quarter’s revenue, $13.8 million, came from outside the U.S., where patients have access to both the 90-day and 180-day Eversense versions.

180-day trial

Only the 90-day sensor is available in the U.S., but Senseonics is working to change that. A 180-day clinical trial at several sites across the country is fully enrolled, and by the end of December, all of the participants will have hit the 90-day mark. Senseonics plans to do an interim analysis using that data to look for evidence of interoperable CGM (iCGM) capability, a classification the FDA has started to offer for disparate insulin pumps, CGMs and software that can be combined to form individualized closed-loop systems. If the accuracy numbers check out, the company will apply to the FDA for iCGM status, Kaufman said.

The 180-day trial is expected to end in late spring of 2020, and Senseonics is hoping to file a submission with the FDA by early summer and commercialize the 180-day Eversense sensor in the U.S. by the end of the 2021 first quarter.

The longitudinal performance study also could boost efforts to expand coverage for Eversense, both in its 90-day indication and once the 180-day sensor is approved. CMS finalized a national payment rate for Eversense earlier this month, making it the first CGM to be reimbursed through Part B medical services.

“One of the questions that we were asked early on is can we show that it’s durable over time, because [for] most of the studies … one sensor is all they need to see in the same patient,” Kaufman said. “Now we’ve shown that repeated sensors have the same outcome, so we do think that will be important for other payers as well.”

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