--News Direct--
By Meg Flippin, Benzinga
Managing diabetes has gotten an overhaul thanks to continuous glucose monitoring devices (CGM).
Glucotrack Inc. (NASDAQ: GCTK), the Rutherford, New Jersey medical technology company that makes a continuous blood glucose monitoring (CBGM) device, is seeking to position itself to transform the glucose monitoring market. It is doing so through what it says is a game-changing medical technology that overcomes the challenges of the existing devices on the market, including the lack of real-time accuracy, the need for frequent sensor changes and concerns regarding comfort and wearability.
Glucotrack’s implantable Continuous Blood Glucose Monitor (CBGM) measures glucose in the blood, something no other known competitor is offering to date. By measuring glucose in the blood instead of glucose in interstitial fluids – which is what most other devices measure – users get an accurate, real-time reading.
Plus, Glucotrack’s implant can last up to three years, compared to less than one year for many of the continuous glucose monitoring (CGM) devices on the market. Patients don’t have to worry about sticking an adhesive to their body or be concerned about it falling off during physical activity, whether it's swimming or hot yoga. The CBGM, which also requires minimal calibration, eliminates the hassle and discomfort of a wearable that requires frequent replacement, the company said.
Making The Rounds
Glucotrack has been busy getting the word out about the potential of its CBGM. In June, it presented two posters at the American Diabetes Association (ADA) 84th Scientific Sessions discussing preclinical animal studies and a sensor longevity simulation modeling for its CBGM. The ADA Scientific Sessions is one of the premier diabetes conferences which provides a platform for the latest advancements in diabetes research, prevention and care. This annual meeting provides researchers and healthcare professionals with the opportunity to share ideas and learn about cutting-edge technologies and breakthroughs in diabetes research and diabetes-related conditions.
Glucotrack also presented an emerging science industry poster at the Association of Diabetes Care and Education Specialists annual conference, which took place from Aug. 9 to 12. The poster presented market research data on the acceptance of the company’s CBGM concept among people with type 1 and type 2 diabetes. It highlighted that out of 757 respondents with type 1 and type 2 diabetes using a variety of insulin regimens, there was a positive sentiment towards the CBGM concept, with over 50% of potential users open to adopting the product. In other words, the CBGM concept could be a viable alternative to existing products on the market.
PreClinical Trials In The Bag
Glucotrack’s data so far seems to back up its claims, including its recent 90-day preclinical study demonstrating the sustained accuracy of its CBGM. The second long-term preclinical study for its CBGM showed a Mean Absolute Relative Difference (MARD) of 4.7% at day 90, which is considered highly accurate for a continuous glucose monitor, reports Glucotrack. MARD is a key metric used to assess the accuracy of glucose monitoring devices, measuring the average difference between the CBGM device’s measurement and a reference measurement, most often obtained via capillary blood glucose. Lower values indicate better performance, said Glucotrack.
The company said the 90-day preclinical study, which included a larger number of animal subjects and a longer duration than the initial 60-day study announced earlier this year, further validates the CBGM’s sustained accuracy and performance.
“We are again very pleased with the performance of our sensor during a long-term preclinical study and look forward to moving into human clinical trials,” stated Paul Goode, PhD, president and CEO of Glucotrack.
“Our CBGM’s ability to continuously measure blood glucose for 3 years with accuracy, minimal calibration and without a wearable device represents a significant advancement in glucose monitoring. We believe this technology has the potential to greatly improve the quality of life for people with diabetes by providing a more convenient and discreet monitoring solution,” he said.
Cashing In
All of these developments seem to have brought Glucotrack investment money; in July, the company secured $4 million in funding from its leading shareholder to support its upcoming first in-human clinical trial. It also helps the company that it has a deep leadership bench and board with years of experience.
Take Goode, for starters. He has decades of experience developing innovative medical technologies in the implantables and glucose monitoring space for big-name medical technology companies, including DexCom Inc. (NASDAQ: DXCM), a global continuous glucose monitoring company.
Goode is a named inventor on over 150 issued patents, including over 100 relating to Dexcom’s continuous glucose sensing technology. Meanwhile, Mark Tapsak, Ph.D., VP of Sensor Technology, has held senior positions at diabetes management companies, including as senior scientist at DexCom.
Further, the bench just got deeper with the appointment of Andy Balo – a former DexCom executive – to the board. Balo brings decades of regulatory, clinical and quality experience in the medical technology industry. In 2002, he joined DexCom as part of the original executive team where he remained for the next 22 years, playing a key role in shaping the company’s future. During his tenure, he was responsible for numerous glucose monitoring regulatory submissions and clinical trials worldwide, and coordinated quality activities across multiple manufacturing facilities.
With a forecasted CAGR of 10.3% over 2024-2034, the continuous glucose monitoring market could be poised to take off, and Glucotrack wants to play a role in expanding options for patients with its technology. With preclinical trials already being in the bag, and human trials up next - the company feels its commitment to that goal is progressing steadily toward fruition.
Featured photo by Mykenzie Johnson on Unsplash.
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