Last summer, GlucoTrack reported preliminary results from a feasibility study of its implantable continuous glucose monitor technology indicating that the sensor could indeed remain safely implanted for at least two years.
Now, a new set of early study results have suggested that in addition to offering a longer-term alternative to standard CGMs, GlucoTrack’s technology also shows promise in improving on its competitors’ accuracy.
The new results come from the implanted CGM’s first preclinical study, which is now complete, according to a company announcement Tuesday.
The study was designed primarily to test the device’s implant technique and overall safety, but also included a small assessment of its accuracy. Among that subset of the sensors put to the test in the study, the technology achieved a mean absolute relative difference, or MARD, of 8.1% after one month, which improved to a whopping 4.5% after two months.
MARD is a common indicator of CGM accuracy and describes how near a device’s blood sugar readings are to a patient’s actual glucose levels. A CGM with a MARD under 10% is considered suitably accurate; for comparison, Senseonics’ Eversense six-month implanted CGM has scored a MARD of 8.5%, while both Dexcom and Abbott are in hot pursuit of non-implanted CGM technology that can consistently produce a sub-8% MARD.
Elsewhere, in its primary focus, the study showed that GlucoTrack’s device can be safely put in place in a 20-minute implant procedure, in which it’s inserted under the skin and connects to a lead positioned in a blood vessel. The company attributed the ease of the process to the incorporation of techniques, tools and device designs found in commonly used implanted heart devices.
“The intravascular approach creates a system that is truly differentiated in the diabetes market,” CEO Paul Goode, Ph.D., said in this week’s announcement. “By measuring glucose in the blood, our system operates in a way that is comparable to what people expect with conventional fingerstick blood glucose monitoring. And, we accomplish this on a continuous basis with long-term use, improved simplicity, and increased discretion.”
Bolstered by the results from its first round of preclinical and feasibility studies, GlucoTrack is now planning to begin its first human studies of the technology later this year.
In the meantime, it has also kicked off a larger and longer-term preclinical study using a “refined prototype” of the implant that’ll be used to assess both accuracy and longevity.