Glucotrack Inc. has successfully completed its first human trial of an innovative intravascular continuous blood glucose monitor, marking a significant milestone in diabetes management technology. The study, conducted at InCor Hospital in São Paulo, Brazil, evaluated the safety and technical feasibility of a fully implantable device designed to address critical challenges faced by insulin-dependent diabetes patients. Current continuous glucose monitoring technologies suffer from several limitations, including measurement of interstitial fluid instead of blood, visible and potentially irritating wearable devices, and frequent sensor replacements. Glucotrack's continuous blood glucose monitor aims to overcome these obstacles by providing a discreet, long-lasting solution that measures glucose levels directly from the bloodstream.
The initial feasibility study enrolled six adult participants with type 1 and type 2 diabetes, all undergoing intensive insulin therapy. Researchers implanted the continuous blood glucose monitor sensor intravascularly and monitored participants for four days, with follow-up assessments to ensure patient safety. The study achieved its primary endpoint of no serious adverse events and demonstrated impressive technical performance, including a 99% data capture rate and a Mean Absolute Relative Difference of 6.7% when compared to traditional fingerstick glucose monitoring. Building on these promising results, Glucotrack is preparing to launch a long-term, multi-center clinical trial outside the United States. This prospective study will involve up to 30 participants and assess the commercial version of the continuous blood glucose monitor system, including the implantable sensor, subcutaneous electronics module, and companion mobile application. Participants will undergo continuous monitoring for at least one year, with potential extension to three years.
The significance of this research extends beyond technological innovation. With 38.4 million Americans living with diabetes, and approximately 1.7 million adults with type 1 diabetes requiring insulin, a more efficient and less invasive glucose monitoring solution could dramatically improve patient care and quality of life. By measuring blood glucose levels in real-time and potentially reducing complications associated with diabetes, Glucotrack's technology represents a potential breakthrough in chronic disease management. While the technology is still in early stages, the successful transition from preclinical animal models to human trials represents a critical milestone. The upcoming trial will focus on validating the device's durability, usability, and sustained accuracy – key factors in bringing this potentially transformative medical technology to market. The company's progress can be followed through their official communications at https://www.glucotrack.com.
