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Biotech Daily Dose

Glucotrack's Investigational Cont. Glucose Monitor Shows Accuracy In First-In-Human Study

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

Glucotrack, Inc. (GCTK) announced final results Wednesday from its completed first-in-human study of its investigational Continuous Blood Glucose Monitor or CBGM, presented at the American Diabetes Association's 85th Scientific Sessions.

The study evaluated Glucotrack's long-term, implantable CBGM, which measures glucose directly from blood rather than interstitial fluid.

The trial enrolled 10 patients with Type 1 or Type 2 diabetes on intensive insulin therapy and was conducted at Instituto do Coração in São Paulo, Brazil.

According to the final analysis, the CBGM achieved a Mean Absolute Relative Difference or MARD of 7.7 percent across 122 matched data points and demonstrated a 99 percent data capture rate, with no device- or procedure-related serious adverse events reported.

In addition, 92 percent of glucose values were within the clinically safe 'green zone' on the Diabetes Technology Society Error Grid.

The device showed minimal lag versus venous blood glucose and consistent performance during glucose tolerance testing.

The fully implantable system includes a sensor lead placed in the subclavian vein and subcutaneous electronics that transmit data to a mobile app. The sensor is designed for 3-year use without an external wearable.

Glucotrack plans to initiate a long-term early feasibility study in third quarter of 2025 to assess safety and durability over an extended period.

The device remains investigational and is not yet approved for commercial use.

Currently, GCTK is trading at $13.39, up by 115.62 percent on the Nasdaq.

For comments and feedback contact: editorial@rttnews.com

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