Medical technology company Glucotrack has successfully completed its first-in-human study for an innovative intravascular Continuous Blood Glucose Monitor (CBGM), 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 glucose monitoring system designed to address critical limitations in current diabetes tracking methods.
With 38.4 million Americans living with diabetes, including 1.7 million adults with type 1 diabetes requiring insulin, the need for more advanced monitoring technologies is paramount. Traditional continuous glucose monitors (CGMs) have significant drawbacks, including measuring interstitial fluid instead of blood, requiring frequent sensor replacements, and using visible, potentially irritating external devices.
Glucotrack's CBGM represents a potential paradigm shift in diabetes management. The device measures glucose directly from the bloodstream, enabling real-time, potentially more accurate readings. During the study, which involved six adult participants with insulin-dependent diabetes, the system achieved a remarkable 99% data capture rate and a Mean Absolute Relative Difference of 6.7% when compared to traditional fingerstick blood glucose monitors.
The first-in-human study's primary objective was to demonstrate the system's safety, with participants monitored closely during a four-day hospital stay. The study successfully achieved its endpoints, experiencing no serious adverse events and resolving minor issues like localized pain and minor bleeding without complications.
Building on this success, Glucotrack is preparing for a comprehensive long-term clinical trial. The Outside-the-United States (OUS) study will enroll up to 30 participants and evaluate the commercial version of the CBGM system, including its implantable sensor, subcutaneous electronics module, and companion mobile application. Participants will undergo continuous monitoring for an initial period of one year, with potential extension to three years.
This advancement could significantly improve diabetes management by providing more consistent, less invasive glucose monitoring. For patients who must constantly track their blood sugar levels, a fully implantable system that offers real-time, accurate readings represents a potential game-changing technology. While further research is needed, Glucotrack's innovative approach demonstrates promising potential for transforming how individuals with diabetes monitor and manage their condition.
