GlucoTrack receives ethical approval from St. Vincent’s HREC for CBGM study

Glucotrack (GCTK) announced it has received ethical approval from the St. Vincent’s Hospital Melbourne Human Research Ethics Committee, HREC, for its long-term clinical study of the Company’s continuous blood glucose monitor, CBGM, in participants with type 1 and type 2 diabetes. The prospective, single arm, multi-center study will enroll up to 30 participants with type 1 and type 2 diabetes mellitus requiring glucose monitoring and intensive insulin therapy. The study will evaluate the device’s performance and safety over an initial period of 1 year. The Company may complete additional submissions to extend the study to 3 years, upon completion of the initial study period. With this approval and per the Australian clinical study process, the Company will now notify Therapeutic Goods Administration, which is Australia’s regulatory authority for therapeutic goods such as medicines, medical devices, and diagnostic tests, before proceeding with enrollment. The first patients are expected to be implanted by July.