When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of urine testing and animal insulin.
At that point, it had not been proven that managing glucose actually mattered, according to Kaufman, and proof didn’t come until 1992 with the conclusion of the DCCT study.
“I’ve seen a lot of innovation,” said Kaufman, chief medical officer at continuous glucose monitoring technology developer Senseonics (NYSE:SENS).
She’s been involved in innovation as well, the latest being the 180-day Senseonics Eversense continuous glucose monitor (CGM), for which FDA approval could be coming very soon.
Data presented in 2021 demonstrated strong accuracy with the 180-day sensor, as the next-generation Eversense matched performance levels compared to the current 90-day sensor available in the U.S., but with calibration reduced to essentially once per day.
In early January, the Germantown, Maryland-based company said it expected approval “in the coming weeks.”
“That approval, like everything, has been delayed and we’re so appreciative of what these agencies have done, being able to bring forth such innovation to combat [COVID-19], so we’re willing to step aside as we all have to be able to get a handle on this pandemic,” Kaufman told Drug Delivery Business News. “So, we’re waiting and we do think it should be imminent.”
An earlier version of the 180-day sensor is already available in Europe, with the same next-generation version nearing FDA clearance also under review in the EU. By doubling the duration of the current offering in the U.S., it halves the number of insertion and removal procedures while also reducing the calibration frequency after day 21 through a new calibration scheme.
Kaufman said that one of the sensor’s tests produced a mean absolute relative difference (MARD) of 8.5%, representing high accuracy.
She pointed to ease-of-use among other innovations that encompass the patient-centric efforts Senseonics has made to improve the CGM system.
“There are innovations with the reduction in calibration scheme as well as improvement in some of the user interaction and chemistry improvement,” Kaufman said. “There are all kind of things that we’re excited about.”
Once Senseonics wins FDA approval, its marketing partnership with Ascensia Diabetes Care comes into play.
“They bring forth a huge presence in the field and in marketing and commercialization,” she said. “It enables us to really focus on what we do best.”
The U.S. rollout for the 180-day Eversense CGM will show the benefits of the partnership, Kaufman said, with commercialization responsibilities falling on Ascensia and product development belonging to Senseonics, which began as an R&D company. The partnership allows Senseonics to keep future innovations within a “robust pipeline” at the forefront of its efforts, Kaufman said.
In a November report, BTIG analysts acknowledged the large market opportunity for Eversense — which, at that time, was expected to win FDA approval by the end of 2021 — but said a premium valuation wasn’t warranted “given the company’s past challenges in commercializing the product and the remaining risks related to commercial execution with its new partner.”
Next steps for Senseonics and Eversense include extending durability to one year, a mark that could be reached with the help of chemistry modifications and fundamental changes in the sensing surface itself.
The company also has plans for pushing the calibration frequency to once per week and adding a battery center that won’t increase the diameter but will marginally increase the length, allowing for the transmitter to be taken off and the device to be used as an intermittent scanning device with devices such as a smartphone.
Kaufman said the potential changes in the pipeline at Senseonics are meant to serve the entire spectrum of people managing their diabetes.
“I still think that we’ll need CGM to be sure things are working well and to understand part of our physiology better,” Kaufman said. “What better device for that in the future than an implantable one that could last a year that you could query when you want to? And when you don’t, you don’t have to get that information. I’m just excited that we’ll have something that will be meaningful through this next evolution of how we manage diabetes.”