Clinical Glucotrack's CGM Implant Clears First Feasibility Study

Glucotrack’s CGM Implant Clears First Feasibility Study

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Continuous glucose monitors (CGMs) have become a breakthrough in diabetes management, revolutionizing blood sugar level monitoring and reducing the need for traditional fingerstick tests. Glucotrack’s CGM system is designed to be implanted under the skin, with the company envisioning a longevity of at least two years for this technology. Early feasibility studies have been promising, demonstrating that the implanted CGM sensor design is highly likely to endure the intended duration. Third-party tests have corroborated these findings, providing further confidence in the system’s durability.

These devices have significantly improved the lives of people with diabetes, although regular maintenance remains necessary, with most sensors requiring replacement every week or two. However, Glucotrack, a company currently developing a new implantable CGM system, aims to extend the lifespan of these devices, potentially quadrupling it compared to existing options.

With favorable lab results in hand, Glucotrack plans to commence long-term animal studies later this year. The company’s CEO, Paul Goode, expressed satisfaction with their progress, as they have already surpassed their goal of projecting a long-term sensor life at least four times longer than current implantable CGMs, without the need for external wearables or frequent calibrations.

No specific timeline for human testing and FDA review was provided, Glucotrack is taking a methodical approach to the development process. They aim to complete the multi-year feasibility study by the end of 2023, along with gathering substantial wet-bench data and animal results. Simultaneously, they will work on designing and developing the human version of the device.

Last year, Glucotrack acquired implantable CGM technology, entering the insulin-dependent diabetes market, primarily catering to individuals with Type 1 diabetes and some with Type 2 diabetes. Their first device was a noninvasive CGM system intended for people with Type 2 diabetes who don’t require insulin. This system, still under development, recently underwent improvements to match industry standards in size and accuracy. It now features ultrasound sensor technology housed in a compact wireless ear clip, providing quick blood sugar readings within two seconds and transmitting them to a smartphone via Bluetooth.

Although some human factors issues were identified during early testing of the redesigned noninvasive CGM, Glucotrack promptly addressed these concerns. They are now moving forward with a human study in the second quarter of this year and plan to construct a commercial version of the device in the third quarter. Subsequent studies will precede the device’s submission for FDA review.

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