Glucotrack (Nasdaq:GCTK) today announced the results from the first-in-human clinical study of its long-term continuous blood glucose monitor (CBGM).
Rutherford, New Jersey-based Glucotrack shared findings at the American Diabetes Association’s 85th Scientific Sessions in Chicago. (See all the biggest stories out of ADA 2025 here.)
Glucotrack’s device features no on-body external component. The company designed it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution. Unlike traditional CGMs that measure glucose in interstitial fluid, the CBGM measures glucose levels directly from the blood. It aims to provide real-time readings without the lag time typically associated with interstitial glucose measurements. Chief Science Officer Mark Tapsak outlined how the system works at ADA.
Conducted at the Interventional Cardiology at Instituto do Coração in São Paulo, Brazil between December 13, 2024 and January 31, 2025, the study evaluated 10 participants with either type 1 or type 2 diabetes on intensive insulin therapy.
The now-completed first-in-human study met all primary and secondary endpoints, Glucotrack announced. It demonstrated excellent accuracy with a mean absolute relative difference (MARD) of 7.7% across 122 matched pairs. Investigators also reported a 99% data capture rate and no procedure- or device-related serious adverse events.
Glucotrack said the findings validate its system’s safety and performance. It leveraged AI-based analytics from OneTwo Analytics to evaluate data and assess clinical value, highlighting that 92% of its CBGM measurement values landed in the “green zone” of the Diabetes Technology Society Error Grid. No measurements landed in the unsafe zones, demonstrating high clinical accuracy, the company said.
The system successfully remained in place throughout the study period and investigators reported successful removal at study completion.
Next, the company plans to initiate a long-term early feasibility study in the third quarter of 2025. It hopes to evaluate safety and performance over an extended period.
“This study represents an important milestone validating our CBGM technology’s potential,” said Paul V. Goode, 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.”
