GlucoTrack (Nasdaq:GCTK) announced today that its second-generation glucose monitor device has shown promising results in analyses.
Rutherford, New Jersey-based GlucoTrack — formerly known as Integrity Applications (Nasdaq:IGAP) — earlier this year completed lab testing of the non-invasive GlucoTrack 2.0 clinical prototype system and has observed better-than-expected accuracy and performance with the technology.
According to a news release, the lab testing process included the testing of multiple iterations of electronics, ear clip and a mobile app with cloud-based software. The company also tested human factors of the mobile app through simulated use in focus groups, plus an external design review for system architecture, stability and cybersecurity.
During in-house testing that followed the bench testing and analyses, GlucoTrack said it observed better thane expected accuracy and performance, with initial data indicating that the GlucoTrack 2.0 may achieve an accuracy comparable to invasive continuous glucose monitors (CGMs) currently available on the market when evaluated in the company’s upcoming first-in-human clinical study.
GlucoTrack will conduct the study at the Rabin Medical Center in Isreal, with initial study results set to drive a follow-up, multi-center study in the U.S., to be led by Dr. Klonoff, Chair of the Company’s Scientific Advisory Board and Medical Director of the Diabetes Research Institute of Mills-Peninsula Medical Center.
The company intends for the U.S. study to represent a precursor to an eventual pivotal trial to be used to garner FDA clearance for the next-generation glucose monitor. The Israel study is slated to begin in the third quarter of this year, with the U.S. study to follow in the fourth quarter.
“I am greatly encouraged by the promising early results of the testing of the Gen 2 clinical prototype system and by the opportunity that lays ahead of us” GlucoTrack President and CEO Paul Goode said in the release. “We thank our shareholders for their encouragement and patience and look forward to providing further updates on our progress.”