Though the latest continuous glucose monitors virtually eliminate the need for people with diabetes to collect fingerstick blood samples to check their blood sugar levels throughout the day, they do still require some upkeep, with most sensors needing to be changed out every week or two. The longest-lifespan CGM currently cleared by the FDA is Eversense’s system, which is implanted under the skin and lasts up to six months.
A new technology currently under development by Glucotrack aims to hugely cut down on that required maintenance—even potentially quadrupling the lifespan compared to the Eversense device.
Glucotrack is looking to market its own implantable CGM system with a longevity of at least two years. So far, the prognosis is good: An early feasibility study has proved that the technology could indeed stay implanted that long, according to an update from the company this week.
The feasibility study was conducted via lab bench testing, and it confirmed that the implanted CGM’s current sensor design is “highly probable” to last at least two years, Glucotrack reported. Those findings were further corroborated by third-party tests that simulated the sensor’s performance over time.
With those early lab results in hand, Glucotrack now plans to begin long-term animal studies of the technology later this year.
“We are pleased to have met our goal to confidently project a long-term sensor life that is at least four times longer than what is currently available for an implantable CGM, without the requirement for external wearables or frequent calibrations,” CEO Paul Goode, Ph.D., said in the announcement.
Glucotrack didn’t provide a timeline for when the system could be ready for human testing and, eventually, FDA review, but appears to be taking the development process one step at a time. In a letter to shareholders in March, Goode said that by the end of 2023, Glucotrack was hoping to have completed the multi-year feasibility study, while also having collected six months’ worth of wet-bench data and three months’ worth of the animal results and begun designing and developing the human version of the device.
Glucotrack acquired the implantable CGM technology last fall, though it didn’t disclose the seller of the IP in that October announcement.
While implanted under the skin for its multiyear lifespan, the device is meant to work without requiring users to wear any external transmitter, and it will only require one calibration at the initial setup.
The tech purchase marked Glucotrack’s first foray into the realm of insulin-dependent diabetes—as the implanted CGM is aimed at that group, which includes all people with Type 1 diabetes and only some of those with Type 2 diabetes. The company’s first device, meanwhile, was a noninvasive CGM system designed for use only by people with Type 2 diabetes who don’t take insulin.
The noninvasive system is still under development. In the March letter, Goode described how the device had recently undergone a makeover to keep up with industry standards for the size and accuracy of CGM systems; its ultrasound sensor technology is now housed in “a smaller wireless ear clip” that collects blood sugar readings within two seconds—compared to the previous 60-second span—and transmits them to a user’s smartphone via Bluetooth.
Early testing of the redesigned system exposed “human factors” causing issues that needed to be fixed, Goode said at the time, but the fixes were expected to be completed quickly, allowing a human study of the system to begin in the second quarter of the year. Glucotrack will use those results to begin constructing a commercial version of the device in the third quarter, he said, which will then be tested in a series of studies before it’s ultimately submitted for FDA review.