- Glucotrack’s device showed a 7.7% MARD, 99% data capture, and zero serious adverse events in a human trial.
- The device measured glucose from blood, not fluid, and had 92% values in the green zone per DTS Error Grid.
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Glucotrack Inc. GCTK stock traded higher on Wednesday, with a session volume of 15.91 million compared to the average of 81.7K, according to data from Benzinga Pro.
The diabetes-focused medical device company announced results on Wednesday from its completed first-in-human clinical study presented at the American Diabetes Association.
The study met all primary and secondary endpoints, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, a 99% data capture rate, and no procedure or device-related serious adverse events.
These findings validate the safety and performance of the company’s long-term, implantable Continuous Blood Glucose Monitor (CBGM). This monitor measures glucose from blood rather than interstitial fluid, eliminating the typical lag time associated with traditional continuous glucose monitoring systems.
Glucotrack leveraged OneTwo Analytics’ next-generation artificial intelligence and machine learning-based analytics to evaluate the data and assess its clinical value.
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Analysis using the Diabetes Technology Society Error Grid showed that 92% of the CBGM measurement values were in the green zone and none were recorded in the unsafe zones, demonstrating very high clinical accuracy compared to the reference blood glucose values.
The study, which was conducted in Brazil between December 13, 2024, and January 31, 2025, included ten participants with either Type 1 or Type 2 diabetes who were on intensive insulin therapy.
Following the device placement, each participant underwent inpatient observation for 4 days.
During this period, frequent blood sampling and glucose tolerance tests were conducted to assess device performance. Detailed analysis showed consistent performance during glucose tolerance testing with minimal lag time compared to venous blood samples.
The system remained in place throughout the study period and was removed at completion. Patients were then followed for seven days after removal.
Glucotrack expects to initiate a long-term early feasibility study in the third quarter of 2025. This study will evaluate safety and performance over an extended period, bringing the technology closer to its goal of providing patients with a less-intrusive alternative to continuous glucose monitoring.
Unlike traditional continuous glucose monitors, the Glucotrack CBGM is a fully implantable monitor.
It consists of a sensor lead implanted into the subclavian vein and connected to subcutaneous electronics that communicate with a mobile application.
Designed for a three-year sensor life and continuous, accurate blood glucose monitoring, the system offers a more convenient and less intrusive solution for people with diabetes. It has no on-body wearable component and minimal calibration requirements.
The Glucotrack Continuous Blood Glucose Monitor is an Investigational Device.
Price Action: GCTK stock is up 59.9% at $9.93 at the last check on Wednesday.
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