Introduction & Objective: This study provides the first in vivo assessment of Glucotrack's long-term implantable Continuous Blood Glucose Monitor (CBGM) in an ovine model. The primary objectives were to evaluate device performance, assess and refine implantation techniques, and examine chronic gross biocompatibility through explant and necropsy.
Methods: Two adult male sheep were selected for the study, each receiving 2 intravascular device implants—one each in the left and right jugular vein. MARD (CBGM-BGM) scores were calculated at 30 and 60 days post-implantation. Regular blood glucose measurements were performed twice weekly. Glucose excursions were conducted twice during the study and compared against conventional blood glucose monitoring values measured in triplicate. Comprehensive blood analyses were performed at the beginning and end of the study.
Results: The results demonstrated successful intravascular implantation (~20 minutes) without sophisticated techniques or tools. During the study, no serious adverse events were observed. Notably, MARD improved over time, indicating sustained accuracy of the Glucotrack CBGM. MARD average across the 4 devices was 8.1% at Day 30 and 4.5% at Day 60.
Conclusion: Glucotrack’s CBGM may be a reliable and accurate long-term solution for humans managing diabetes mellitus.
M.A. Tapsak: Employee; Glucotrack Inc. P. Goode: Employee; Glucotrack Inc. J. Thrower: Employee; Glucotrack Inc. M.R. Talcott: Employee; AbbVie Inc. Consultant; Stereotaxis, GlucoTrack, Medibeacon. J. Garcia: Consultant; Glucotrack. T. Routh: Employee; GlySens Incorporated, Biolinq. Consultant; GlucoTrack Incorporated. S. Tapsak: Employee; Glucotrack, Inc.
