Glucotrack (Nasdaq:GCTK) today announced another publication of data supporting its long-term implantable glucose sensor.
The latest data, published in The Journal of Diabetes Research, follows a publication last week supporting the system’s feasibility. This study evaluated the long-term accuracy and stability of the fully implantable blood glucose monitoring (CBGM) system in an in-vivo ovine model.
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.
Currently, Senseonics produces the only long-term, implantable CGM on the market — a one-year device.
Glucotrack’s latest study evaluated the CBGM’s in-vivo performance in an ovine model over periods of up to 240 days. The study examined 34 devices successfully implanted into 17 adult sheep.
Results demonstrated a weighted average mean absolute relative difference (MARD) of 6.8% across 79 intravenous glucose tolerance tests conducted during the study period, highlighting the system’s accuracy. Previous first-in-human results demonstrated a highly accurate mean absolute relative difference (MARD) of 7.7% and a 99% data capture rate. Those results also included no procedure- or device-related serious adverse events.
In the sheep, the devices maintained consistent glucose sensing performance, with no device-related adverse safety events observed.
Dr. Paul V. Goode, president and CEO of Glucotrack, said:
“The publication of this peer-reviewed study in the Journal of Diabetes Research provides externally validated evidence of the long-term performance of our CBGM technology. Sustained accuracy and consistent device performance over 240 days in a preclinical model reinforces our confidence in the platform’s design. As we advance towards our IDE submission with the FDA, these results support our continued progression toward further clinical development and eventual commercialization.”
