Implantable Device to Redefine Continuous Glucose Monitoring

Monitoring blood glucose levels is essential for individuals with diabetes, yet current continuous glucose monitoring (CGM) systems often fall short on key parameters such as accuracy, calibration frequency, comfort, and wearability. Traditional CGMs rely on interstitial fluid and external wearables, which can pose limitations in usability and long-term convenience. To address these challenges, a new fully implantable continuous blood glucose monitoring (CBGM) system aims to deliver consistent, real-time glucose readings directly from the bloodstream, without the need for daily maintenance or on-body devices.

The fully implantable investigational CBGM system being developed by Glucotrack (Rutherford, NJ, USA) leverages engineering techniques from the cardiovascular field to deliver an implantable monitoring platform designed for long-term, patient-friendly use. The Glucotrack CBGM consists of two core components: a transmitter designed for subcutaneous placement and a glucose sensor lead that is implanted intravascularly. Unlike traditional CGMs that sit on the skin and monitor glucose in interstitial fluid, this device is positioned within the body to continuously measure glucose levels directly from the bloodstream. The system is intended to function for up to three years, reducing the need for frequent calibrations and eliminating external wearables, thereby minimizing daily disruptions for users.

The company recently completed its first human clinical study of the CBGM, evaluating the short-term safety and feasibility of sensor implantation, use, and removal. Conducted in a hospital setting over a four-day period, the prospective single-arm trial involved six participants with diabetes requiring intensive insulin therapy. The sensor lead was inserted into the subclavian vein via a percutaneous procedure and connected to a prototype external component. The study achieved its primary safety endpoint with no device- or procedure-related serious adverse events reported from implantation through seven days after removal. Placement and removal were carried out successfully by interventional cardiologists, and the sensor’s functionality within the vein was confirmed.

By delivering a seamless, long-duration alternative to existing CGMs, Glucotrack’s implantable system has the potential to transform diabetes care. It eliminates the need for surface wearables and frequent user intervention, addressing key pain points in current glucose monitoring practices. If approved, the system could offer people with diabetes a more reliable, comfortable, and less burdensome solution for managing their condition. Beyond glucose monitoring, Glucotrack is exploring the broader potential of its implantable system in other areas of care. One research direction includes assessing continuous glucose sensing in the epidural space for patients with Painful Diabetic Neuropathy (PDN)—a neurological complication of diabetes that causes chronic pain and numbness. This feasibility study may provide new insights into PDN management and symptom tracking. The Glucotrack CBGM is currently classified as an Investigational Device and is limited by U.S. law to investigational use only.

“Our long-term CBGM system is designed to measure glucose directly from the blood-an approach that could redefine how diabetes is managed by offering real-time, accurate readings without the burden of wearables,” said Paul V. Goode, PhD, President and Chief Executive Officer. “We’re excited to share the compelling findings from our first-in-human study and to continue building momentum as we prepare for the next clinical phase with our long-term feasibility study.”

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