Clinical TrialApr 30, 2026, 09:02 AM
GCTK CBGM Study Shows 6.8% MARD Over 240 Days in Ovine Model
AI Summary
Glucotrack, Inc. announced the publication of a peer-reviewed scientific article in The Journal of Diabetes Research, detailing the long-term accuracy and stability of its fully implantable continuous blood glucose monitoring (CBGM) system. The study, conducted in an ovine model, demonstrated a weighted average Mean Absolute Relative Difference (MARD) of 6.8% over periods of up to 240 days, with no device-related adverse safety events. This externally validated evidence reinforces the company's confidence in the CBGM platform and supports its continued progression towards an IDE submission with the FDA for further clinical development and eventual commercialization.
Key Highlights
- Peer-reviewed study on Glucotrack's implantable CBGM published in The Journal of Diabetes Research.
- Study evaluated in-vivo performance in an ovine model for up to 240 days.
- Demonstrated a weighted average MARD of 6.8% across 79 intravenous glucose tolerance tests.
- Devices maintained consistent glucose sensing performance for up to 240 days.
- No device-related adverse safety events were observed during the study period.
- Results reinforce confidence in the platform's design and support progression towards FDA IDE submission.
- Previous first-in-human study showed 7.7% MARD with 99% data capture and no serious adverse events.
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