Glucotrack, Inc. announced positive results from its first-in-human clinical study of its implantable continuous blood glucose monitor (CBGM). The study, presented at the American Diabetes Association’s 85th Scientific Sessions, demonstrated a 7.7% MARD, 99% data capture rate, and no serious adverse events. The device measures glucose directly from the blood, potentially eliminating the lag time seen with traditional interstitial fluid-based monitors.
This successful first-in-human study is a crucial step toward potentially revolutionizing continuous glucose monitoring. A device with a high degree of accuracy that measures blood glucose directly could significantly improve diabetes management by providing real-time, reliable data, enabling more precise insulin dosing and better glycemic control. This direct blood measurement could be particularly beneficial for individuals on intensive insulin therapy who rely on accurate and timely glucose readings to avoid hypoglycemic or hyperglycemic events.
The clinical study, conducted in Brazil, involved ten participants with Type 1 or Type 2 diabetes. Data analysis, conducted by OneTwo Analytics, revealed 92% of the CBGM measurements fell within the clinically acceptable “green zone” of the Diabetes Technology Society Error Grid. The device was successfully implanted and removed using standard percutaneous techniques, and patients were monitored for seven days post-removal. The device remained functional and in place for the duration of the study period, suggesting good short-term stability and biocompatibility.
Glucotrack plans to initiate a long-term feasibility study in Q3 2025 to further evaluate safety and performance over an extended period. Positive results from this upcoming study will pave the way for larger clinical trials and ultimately commercialization, potentially offering a less burdensome and more accurate continuous glucose monitoring option for patients. The development of a long-term, implantable CGM with a high degree of accuracy could shift the paradigm of diabetes management and improve patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
