Glucotrack (Nasdaq:GCK) announced today that it completed the first preclinical study of its implantable continuous blood glucose monitor (CBGM).
Rutherford, New Jersey-based Glucotrack aimed to assess the implant technique and device safety in the study. Additionally, the study used a small sample size of sensors to determine device functionality.
Despite no intent to conduct an accuracy study, the company reported a mean absolute relative difference (MARD) of 8.1% at day 30 and 4.5% at day 60. Glucotrack reported no significant adverse events.
“We are extremely pleased with these initial results demonstrating that the sensor is both safe and capable of a high level of accuracy,” said Paul Goode, CEO of GlucoTrack. “Because this study was performed using initial prototype devices, we expect to see similar results with improved prototypes that are manufactured using refined production techniques. So, we are very confident as we continue to advance our development program and as we share more information about our novel approach.”
Glucotrack developed the CBGM to utilize an intravascular approach. Implanted subcutaneously, the sensor connects to a lead placed directly into a blood vessel. The company says it facilitates continuous blood glucose measurements with zero lag time. Comparatively, the company says many common CGM systems measure glucose in interstitial fluid, which lags behind blood glucose.
The company said it based its approach on design elements, implant techniques and tools commonly used for implantables in the cardiovascular space. Its initial preclinical study demonstrated a simple implant procedure lasting approximately 20 minutes.
Glucotrack expects first-in-human studies to start later this year.
“The intravascular approach creates a system that is truly differentiated in the diabetes market,” Goode said. “We believe that our implantable CBGM technology will be a significant advancement for the millions of people living with diabetes.”
