Medical technology company Glucotrack has successfully completed its first human trial of a novel continuous blood glucose monitoring system, potentially revolutionizing diabetes management for insulin-dependent patients. The study, conducted at InCor Hospital in São Paulo, Brazil, demonstrated the safety and technical feasibility of an intravascular monitoring device that measures blood glucose levels directly.
The first-in-human study enrolled six adult participants with type 1 and type 2 diabetes, all undergoing intensive insulin therapy. Researchers implanted an intravascular sensor connected to prototype electronics, monitoring participants for four days. The primary endpoint of the study—absence of serious adverse events—was achieved, with only minor issues such as localized pain and minor bleeding reported.
Key performance metrics were promising, with the device achieving a 99% data capture rate and a Mean Absolute Relative Difference of 6.7% when compared to traditional fingerstick glucose monitors. This represents a significant improvement over current continuous glucose monitoring technologies, which measure interstitial fluid and can experience delays during rapid glucose level changes.
The breakthrough device offers several potential advantages over existing monitoring systems. Unlike current wearable continuous glucose monitors, Glucotrack's system is fully implantable, discreet, and designed for a multi-year lifespan with minimal calibration requirements. This could substantially improve quality of life for diabetes patients who currently rely on external patches and frequent sensor replacements.
Following the successful initial trial, Glucotrack is preparing to launch a long-term outside-the-United-States clinical trial. This prospective, multicenter study will enroll up to 30 participants and assess the commercial version of the continuous blood glucose monitoring system over one year, with potential extension to three years.
The implications of this technology are significant for the approximately 38.4 million Americans living with diabetes. By providing real-time, accurate blood glucose measurements, the device could help patients better manage their condition and potentially reduce the risk of complications affecting major organs.
