Glucotrack completes first human clinical study for CBGM

RUTHERFORD, N.J. — Glucotrack has successfully completed its first in-human clinical study for the first real-time, continuous blood glucose monitor (CBGM) placed in the subclavian vein. CBGMs offer the potential for direct measurement without the limitations often seen with traditional continuous glucose monitors measuring glucose levels in interstitial fluid. “We are thrilled with the results of this first in-human clinical study, which establishes safety of the placement, usage and removal of the CBGM sensor lead,” said Paul V. Goode, PhD, president & CEO of Glucotrack. “While neither the study nor prototype system was designed to evaluate sensor accuracy, the system performed as expected with similar accuracy results as previously seen in our animal studies. With these positive results, the promise of continuous blood glucose monitoring is one step closer to reality.” The prospective single-arm study was a short-term, in-hospital study over a period of four days, focusing on the safety and procedural aspects of the CBGM sensor lead placement, use and removal. The CBGM sensor lead was placed intravascularly via a percutaneous procedure and connected to a prototype sensor electronics component that was placed on the skin. The six study participants had been previously diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin therapy. The CBGM is a long-term implantable device with no on-body external component, designed for three years of continuous, accurate blood glucose monitoring, offering a more convenient and less intrusive glucose monitoring solution.