Glucotrack’s implantable CGM shows clinical accuracy

RUTHERFORD, N.J., and STOCKHOLM — Glucotrack announced the results from its completed first-in-human clinical study of its implantable continuous glucose monitor (CGM) at the American Diabetes Association’s (ADA) 85th Scientific Sessions June 20-23, 2025, in Chicago. Using OneTwo Analytics’ next-generation artificial intelligence and machine learning-based analytics to evaluate the data and assess its clinical value, Glucotrack showed that 92% of the CGM's measurement values were in the green zone and none were recorded in the unsafe zones, demonstrating very high clinical accuracy when compared to the reference blood glucose values. “This study represents an important milestone validating our CBGM technology’s potential,” said Paul V. Goode, PhD, president and CEO of Glucotrack. “With a MARD of 7.7%, which is comparable to leading CGM systems but with direct blood measurement instead of interstitial fluid, we’re advancing our novel technology into further clinical trials, taking us closer to providing patients with a long-term, less burdensome solution for diabetes management. We are excited to be sharing our data at this important industry congress.” Glucotrack expects to initiate a long-term early feasibility study in Q3 2025, which will evaluate safety and performance over an extended period, bringing the technology closer to its goal of providing patients with a less-intrusive alternative to continuous glucose monitoring. The study, which was conducted at the Interventional Cardiology at Instituto do Coração in São Paulo, Brazil, between Dec. 13, 2024, and Jan. 31, 2025, included 10 participants with either Type 1 or Type 2 diabetes who were on intensive insulin therapy. Following device placement, each participant underwent inpatient observation for four days. During this period, frequent blood sampling and glucose tolerance tests were conducted to assess device performance. Detailed analysis showed consistent performance during glucose tolerance testing with minimal lag time compared to venous blood samples. The system successfully remained in place throughout the study period and was successfully removed at study completion, with patients then followed for seven days post-removal.