Glucotrack has successfully completed a first-in-human study with its continuous glucose monitor (CGM) that directly measures glucose levels from a blood vessel.

The company’s system is placed in the subclavian vein, a blood vessel that runs under the collar bone bringing deoxygenated blood back to the heart. Glucotrack calls its device, which has no external on-body component, a continuous blood glucose monitor (CBGM).

The implant is around the length and thickness of three US nickels, with a total volume of 2.5cc. This makes the device smaller than many implantable medical devices such as pacemakers, which have a volume of around 8cc.

The prospective single arm study was a short-term study conducted at the Instituto do Coração (InCor) of the Hospital das Clínicas of Faculdade de Medicina da Universidade de São Paulo in Brazil. Six participants, who all had diabetes and required glucose monitoring with insulin therapy, had the CBGM placed intravascularly via a percutaneous procedure. The sensor was then connected to a prototype sensor electronics component placed on the skin as patients underwent several fixed meal and glucose challenges.

The study met its primary endpoint with no procedure or device related serious adverse events across a week, at which point the CBGM sensor lead was removed. The study also demonstrated the functionality in using the subclavian vein for blood glucose measurement.

CGMs have come on leaps and bounds since the first marketed system by Minimed in 1999. Allowing diabetes patients access to real-time blood glucose levels, the technology has helped empower individuals to take greater control of their health. The systems have also significantly helped doctors to provide more personalised treatment. The landscape took a big step forward in accessibility when Dexcom won US Food and Drug Administration (FDA) clearance for the first over the counter (OTC) CGM in June 2024. Dexcom is the CGM market leader in the US with 74% of the market share, according to analysis by GlobalData. The company also recently teamed up with ŌURA to combine diabetes management with consumer health technology.

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Despite their effectiveness, Glucotrack states there are still limitations seen with conventional CGMS placed subcutaneously. Most systems from Dexcom and Abbott are replaced every one to two weeks, whereas Glucotrack says it has designed its CBGM for three years of continuous use. This, the company says, can offer more convenient solution.

Glucotrack’s CEO Paul V. Goode told Medical Device Network: “In a survey of 757 patients, we found significant interest in an implantable continuous glucose monitor. The most appealing features were long-term sensor life, direct blood glucose measurement and lack of a wearable component. More than 50% of respondents indicated they were open to and likely to adopt such a device.

“We are planning multiple clinical studies, including a long-term implantable trial later this year and a U.S. pivotal trial anticipated in 2026,” Goode added.

Clinical professor of medicine at University of California, San Francisco David Klonoff commented: “The successful completion of this first in human study with no serious adverse events is encouraging. The study suggests that this approach could offer another alternative for continuously monitoring glucose levels in diabetes, and I look forward to seeing this technology advance into long-term clinical trials.”

Glucotrack is not the only company seeking a more convenient solution for glucose monitoring. Biolinq has developed a small, non-invasive device placed on the arm that uses an array of electrochemical sensors.

The global CGM sensor market is expected to grow to more than $5bn in 2033, up from $3.5bn in 2023, according to analysis by GlobalData.