Glucotrack, Inc. has successfully completed its first human clinical study of a continuous blood glucose monitor (CBGM) implanted in the subclavian vein. The study focused on the safety of the device’s placement, usage, and removal in six participants with diabetes requiring intensive insulin therapy. No procedure or device-related serious adverse events were reported.
This successful initial human study is a crucial step towards potentially revolutionizing continuous glucose monitoring for diabetes patients. Current continuous glucose monitors rely on measuring glucose in interstitial fluid, which can be less accurate and timely than direct blood glucose measurement. Glucotrack’s CBGM, implanted directly into the bloodstream, promises more accurate and real-time data, potentially leading to better glucose control and improved outcomes for patients. This advancement could also significantly impact diabetes management by reducing the need for frequent finger-prick tests and offering a more convenient, long-term solution.
The four-day in-hospital study involved placing the CBGM sensor lead intravascularly and connecting it to a prototype electronics component on the skin. The primary endpoint of safety was met, and the study confirmed the functionality of the sensor lead within the subclavian vein. While the study was not designed to assess accuracy, the prototype system performed as expected based on prior animal studies. Interventional cardiologists successfully performed the placement and removal procedures. The company is developing the CBGM as a long-term implantable device, aiming for a sensor longevity of three years with no external wearable component.
This positive outcome paves the way for Glucotrack to move forward with larger, longer-term clinical trials to further evaluate the safety, efficacy, and accuracy of the CBGM system. This development holds promise for a significant advancement in diabetes technology, potentially transforming how patients manage their condition and ultimately improving their quality of life.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
