In Vivo Evaluation of a Novel Long-Term Intravascular Implantable Continuous Blood Glucose Monitor in an Ovine Model: A Glucotrack Inc. Investigation

Implantable intravascular continuous blood glucose monitors (CBGMs) offer a promising approach for accurately measuring glucose levels with short lag times and improved reliability when compared with conventional laboratory-based point-of-care or handheld glucometers. In this study, 34 Glucotrack long-term intravascular CBGM devices were implanted into 17 adult sheep, with one device placed in each jugular vein. Each implantation was completed in approximately 20 min and did not require any customized tools or techniques. Intravenous glucose tolerance tests (IVGTTs) were performed approximately monthly throughout the studies (30–240 days postimplantation) and mean absolute relative difference (MARD) values were calculated against an Accu-Chek Guide handheld glucometer as the reference standard. The weighted average MARD was 6.84% for all 34 devices during a total of 79 IVGTTs. In addition, no device-related adverse safety events were observed during this long-term in vivo proof-of-concept evaluation.