Glucotrack Inc. (NASDAQ: GCTK) announced plans to submit an Investigational Device Exemption application to the U.S. Food and Drug Administration during the second quarter of 2026 for its continuous blood glucose monitoring technology.

The medical technology company completed its first-in-human clinical trial in Brazil between December 2024 and January 2025, involving 10 participants with Type 1 or Type 2 diabetes. The five-day study assessed the insertion, use and removal of an intravascular lead connected to external electronics at Instituto do Coração in São Paulo.

The trial achieved a Mean Absolute Relative Difference of 7.7% across 122 matched pairs with a 99% data capture rate and no device-related serious adverse events, according to the company's statement. The study met all primary and secondary endpoints.

Glucotrack initiated a follow-up feasibility trial in July 2025 at St Vincent's Hospital in Melbourne, Australia. The company reported similar system performance to the Brazilian study while gathering protocol and product insights for future trials.

The company secured a U.S. clinical trial site and engaged a Clinical Research Organization experienced with diabetes medical technology to manage the planned study. Glucotrack expects to begin the U.S. trial in the second half of 2026, pending FDA approval of its IDE submission.

The U.S. Patent and Trademark Office issued three patents to Glucotrack in October and November 2025, covering sensor chemistry, intravascular lead design and low-power electronics for its continuous blood glucose monitoring platform. The device is designed for three-year sensor longevity.

The company's technology measures glucose directly from blood rather than interstitial fluid, which the company states eliminates lag time associated with traditional continuous glucose monitoring systems.