Glucotrack announced the completion of a second long-term preclinical study for its implantable continuous blood glucose monitor (CBGM).
The study further validates the CBGM’s sustained accuracy, the company says. It demonstrated a mean absolute relative difference (MARD) — a measurement of CGM accuracy — of 4.7% at day 90.
MARD measures the average difference between the CBGM device’s measurement and a reference measurement. Lower values indicate better performance.
Glucotrack’s CBGM measures glucose in the blood without the lag time associated with subcutaneous sensors measuring glucose in interstitial fluid. It directly measures blood glucose in real time and on a continuous basis. The company says this enables a less burdensome approach to glucose monitoring over extended periods of time.
The 90-day preclinical study included a larger number of animal subjects and a longer duration than the company’s initial 60-day study. It incorporated periodic glucose tolerance testing to compare the performance of the Glucotrack CBGM against a commercially available blood glucose monitor and a subcutaneous CGM. The company said it completed the study with no significant adverse effects.
Glucotrack plans to initiate human clinical trials later this year.
“We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials,” said Paul Goode, CEO of Glucotrack. “Our CBGM’s ability to continuously measure blood glucose for 2+ years with accuracy, minimal calibration and without a wearable device represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution.”