GlucoTrack Moves Toward Human Trials of Implantable Continuous Blood Glucose Monitor

GlucoTrack offered updates about initial and long-term preclinical studies for its implantable Continuous Blood Glucose Monitor (CBGM).
 
The Rutherford, N.J.-based company successfully finished the CBGM’s first preclinical study, which assessed implantation technique and the device’s safety in patients. A small sample size of sensors was also used to determine device functionality.
 
The company said although though it wasn’t meant to be an accuracy study, the sensor showed Mean Absolute Relative Difference (MARD) of 8.1% at 30 days and 4.5% at 60 days. No adverse effects were reported and the study showed an implant procedure of about 20 minutes.
 
The CGBM device is implanted subcutaneously, then connected to a lead that’s placed into a blood vessel. GlucoTrack noted that this compares to CGM systems that measure glucose in interstitial fluid, which lags behind blood glucose.
 
The company said it leveraged design elements, implant techniques, and implant tools commonly used for cardiovascular active implantable devices.
 
“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, Ph.D., 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.”
 
The company also revealed it began long-term preclinical testing to assess sensor accuracy and longevity with a refined prototype and larger sample size.
 
“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. We believe that our implantable CBGM technology will be a significant advancement for the millions of people living with diabetes,” said Goode.
 
GlucoTrack shared positive results for a feasibility study of implantable CBGM in October. The company expects to initiate first-in-human studies later this year.