Glucotrack announced plans to file an Investigational Device Exemption (IDE) with the FDA in Q2 2026, a key step toward launching a U.S. clinical trial for its fully implantable Continuous Blood Glucose Monitor (CBGM).
Unlike traditional CGMs which measure glucose from interstitial fluid, Glucotrack's CBGM reads glucose directly from the bloodstream. That distinction matters: interstitial readings can lag behind actual blood glucose levels by around 10 minutes, which is a limitation during rapid glucose fluctuations.
The device is also designed to last up to three years, with no on-body wearable component and minimal calibration required. For people getting tired of swapping sensor every 7 to 14 days or having sensors fall off early, this kind of longevity would be a meaningful shift.
This milestone comes off the back of two overseas clinical trials. The first, completed in Brazil between December 2024 and January 2025, enrolled 10 people with type 1 or type 2 diabetes on intensive insulin therapy. Results showed a Mean Absolute Relative Difference (MARD) of 7.7%, a 99% data capture rate, and no serious adverse events. A follow-up feasibility trial in Australia launched in July 2025 and yielded additional protocol and product improvements that have since been incorporated into the next planned study.
Glucotrack expects to begin its U.S. study in the second half of 2026, pending FDA approval.
The timing puts Glucotrack squarely in the middle of a fast-moving race toward fully implantable glucose monitoring. Senseonics already has a one-year implantable CGM on the market with the Eversense 365, but one requires an on-body transmitter. Senseonics has two next-generation systems in development that aim to reduce or eliminate on-body hardware entirely. As we explored in our Future of CGM Tech roundup, implantable blood glucose monitoring could be a key step toward a truly seamless artificial pancreas system.
We had the chance to speak with Glucotrack's CEO & President Paul Goode and Chief Scientific Officer Mark Tapsak about how the implantable CBGM is implanted and how it works on the podcast. You can listen to that conversation here.
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