Glucotrack plans US trial of implantable glucose monitor this year

Glucotrack plans to file for an investigational device exemption in the second quarter, with hopes of starting a trial in the second half of 2026.

Glucotrack said it is ready to start a U.S. clinical trial following progress in other countries. Last year, the company shared results of a first-in-human trial of the device in Brazil.

During the five-day trial, the 10 participants had no procedure- or device-related adverse events, and the device demonstrated a mean absolute relative difference, or MARD, of 7.7%. MARD is an accuracy measurement for CGMs showing the difference between CGM readings and reference blood glucose values.

The company started another feasibility study in Australia in July, with similar performance to the trial in Brazil.

For the planned U.S. study, Glucotrack said it has secured a clinical trial site and found a contract research organization experienced with diabetes technology. The company has also worked on the design of its CGM to improve its functionality and performance.

“With trial infrastructure in place and product enhancements completed, we are prepared to initiate the study, pending FDA approval,” CEO Paul Goode said in a statement.

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