Glucotrack Begins Enrollment for Long-term Implantable CGM StudyGlucotrack Begins Enrollment for Long-term Implantable CGM Study

Glucotrack, a diabetes-focused medtech company, today announced the beginning of patient enrollment for its short-term human clinical trial examining the company’s continuous blood glucose monitor (CBGM) for both type 1 and type 2 diabetes.

Unlike other CGM’s that measure glucose levels via interstitial fluid, according to Glucotrack, its CBGM instead measures glucose directly from blood. Using this method, in turn, can provide real-time readings without CGM’s typically associated lag times. The device is a long-term implantable device with no on-body external component and is designed to be used for three years of continuous and accurate blood glucose monitoring.

The study, which is prospective and single-arm, is a short-term in-hospital trial in which the CBGM will be placed intravascularly for a period of four days. Patients involved in the study — those diagnosed with diabetes mellitus requiring glucose monitoring and intensive insulin therapy — will then participate in several fixed meal and glucose challenges during that period.

The study will be conducted at Instituto do Coração (InCor) of the Hospital das Clínicas of Faculdade de Medicina da Universidade de São Paulo, Brazil, under principal investigator Alexandre Abizaid, MD, PhD, director of interventional cardiology at Instituto do Coração in São Paulo and visiting professor of medicine at Columbia University Medical Center in New York City, NY.

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Study results, according to Glucotrack, is expected to be available within 6-8 weeks.

“Following the success of our preclinical program, we are pleased to reach this key milestone in the development of our novel CBGM,” said Paul V. Goode, PhD, president and CEO of Glucotrack. “We believe this groundbreaking early feasibility study will demonstrate the potential for our real-time continuous blood glucose monitor to offer a truly differentiated and less burdensome approach to glucose monitoring for people with diabetes.”

A red-hot market

The diabetes tech market, especially pertaining to CGMs, has seen many milestones in 2024. In just the latter half of the year, major players in the space have announced FDA nods, collaborations, and significant study milestones.

In early August, Abbott Laboratories and Medtronic announced a collaboration that would have Abbott design a CGM that Medtronic would then sell.  "This partnership pairs two global leaders in glucose sensing technology and insulin delivery," said Jared Watkin, executive vice president of Abbott's diabetes care business, at the time. "Libre technology has set the standard for accurate, accessible, easy-to-use and reliable continuous glucose monitoring. Connecting this CGM built for Medtronic's insulin delivery systems and algorithms makes it easier for people to spend less time thinking about their diabetes and more time living."

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Then in late August, Dexcom launched Stelo, the first over-the-counter CGM, which had been FDA-cleared earlier in the year. “Stelo is a small biosensor worn on the back of the upper arm and is built on the same platform as Dexcom’s G7 CGM sensor,” MD+DI previously reported. “It is specifically designed to provide the 125 million Americans with type 2 diabetes not using insulin and those with prediabetes with powerful, personalized glucose insights sent directly to a smartphone, revealing how food, exercise, and sleep can affect glucose – all without painful finger sticks.”

In September, Abbott also launched its response to an over-the-counter CGM, called Lingo, which was cleared in June. “Glucose is a powerful signal of your body's unique response to food and lifestyle,” said Olivier Ropars, divisional vice president of Abbott's Lingo business, at the time. “Abbott's Lingo tracks your glucose 24/7, translating the data into insights and bridging the gap between traditional healthcare and preventative measures.”

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That same month, Senseonics received FDA clearance for its Eversense 365 CGM, becoming what the company said is the world’s first 365-day sensor of its kind. The start of its commercial launch was reported on Oct.10, when the Eversense 365 was given to its first commercial patient through Mercy’s healthcare system. “The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes,” said Tim Goodnow, PhD, president and CEO of Senseonics, when the clearance was announced. “Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365-day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.”