Glucotrack and OneTwo Analytics have reported promising results from a first-in-human study of a groundbreaking continuous blood glucose monitoring (CBGM) system. Unveiled at the American Diabetes Association’s 85th Scientific Sessions in Chicago, the trial demonstrated both safety and strong clinical accuracy, positioning the implantable device as a potential game-changer in diabetes care.
Unlike traditional continuous glucose monitors that measure glucose levels in interstitial fluid — which typically involves a lag compared to real-time blood glucose — Glucotrack’s CBGM directly measures glucose from the bloodstream. This eliminates delay and offers more precise monitoring, especially critical for patients on intensive insulin therapy. The study, conducted at Instituto do Coração in São Paulo, Brazil, involved ten participants with Type 1 or Type 2 diabetes and achieved a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs. That level of accuracy is in line with leading CGM systems currently on the market.
Importantly, the study met all its primary and secondary endpoints. It achieved a 99% data capture rate and showed no device- or procedure-related serious adverse events. The CBGM device remained fully operational throughout the four-day inpatient observation period, successfully collecting continuous glucose readings and responding reliably to glucose tolerance tests. The system was safely removed at the end of the study, with follow-up confirming continued safety post-removal.
Glucotrack utilized OneTwo Analytics’ artificial intelligence platform to analyze performance metrics and clinical relevance. Their evaluation revealed that 92% of readings fell within the green zone of the Diabetes Technology Society Error Grid — a clear marker of strong clinical alignment with reference blood glucose values. No readings fell into zones that might pose safety concerns.
The device itself is fully implantable, consisting of a sensor lead placed in the subclavian vein and connected to subcutaneous electronics that transmit data to a mobile app. Designed for three years of use, the system offers patients a discreet, low-maintenance alternative to traditional glucose monitors — without the need for an external wearable component.
Looking ahead, Glucotrack plans to launch a long-term feasibility study in Q3 2025 to assess extended performance. If successful, the CBGM system could offer a revolutionary solution to long-standing pain points in diabetes monitoring, reducing burden while improving accuracy and real-time responsiveness.
Image & article source by Glucotrack
