Glucotrack (Nasdaq:GCTK) announced today that it completed the first-in-human clinical study of its continuous blood glucose monitor (CBGM).
The study included participants with both type 1 and type 2 diabetes and began enrolling patients in early December 2024.
Unlike traditional CGMs that measure glucose in interstitial fluid, the CBGM measures glucose levels directly from the blood. It aims to provide real-time readings without the lag time the company says is typically associated with interstitial glucose measurements. Glucotrack’s long-term implantable device features no on-body external component. The company designed it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution.
The short-term, prospective, single-arm in-hospital study placed the CBGM sensor intravascularly for four days via percutaneous procedure. Participants took part in several fixed meal and glucose challenges during the study period. The six subjects were previously diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin therapy.
Glucotrack says the study had the first real-time CBGM placed in the subclavian vein. It met its primary endpoint with no procedure- or device-related serious adverse events from implant through seven days post-removal. The study also confirmed the function of the CBGM sensor lead in the subclavian bein.
“The successful completion of this first in human study with no serious adverse events is encouraging. The study suggests that this approach could offer another alternative for continuously monitoring glucose levels in diabetes, and I look forward to seeing this technology advance into long-term clinical trials,” said Dr. David Klonoff, clinical professor of medicine at University of California, San Francisco and editor-in-chief of the Journal of Diabetes Science and Technology.
