Glucotrack (Nasdaq:GCTK) announced today that it submitted its implantable continuous blood glucose monitor (CBGM) for FDA IDE.
FDA IDE (investigational device exemption) would enable the company to initiate a U.S. clinical study for the fully implantable technology.
Rutherford, New Jersey-based Glucotrack’s device features no on-body external component. The company aims to offer 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.
The implant goes five centimeters within the subclavian vein. Glucotrack’s active implantable device has a small battery and some electronics that go just under the skin in the pectoral region. The location of the implant is not in a major vessel, but the implant can measure real-time glucose levels as pulsatile blood flows over the tip of the sensor.
Currently, Senseonics produces the only long-term, implantable CGM on the market — a one-year device.
Glucotrack continued to progress its system with recent study findings supporting the system’s accuracy and stability. It plans to continue with a U.S. clinical study following FDA review and approval.
Paul V. Goode, president and CEO of Glucotrack, said:
“Submission of our IDE represents meaningful progress in the development of our CBGM technology and underscores our commitment to helping people with diabetes live more fully. Our fully implantable solution is designed to be comfortable and discreet so that people can focus on their daily lives – allowing them to work, exercise, sleep, and socialize without the disruption of frequent sensor changes, visible wearables, or reordering supplies. We look forward to generating the clinical data needed to advance toward regulatory approval and demonstrate that continuous glucose monitoring can be both highly accurate and virtually invisible.”
