Caused predominantly by genetic predisposition, immune disorders and other factors, such as unhealthy diet and exercise habits, diabetes is one of the most common lifelong chronic diseases in the world.
According to the World Health Organization, there are nearly 450 million cases of diabetes worldwide, and the number in the U.S. could reach 40 million by 2030 and more than 60 million by 2060. Many believe the numbers could be more significant because large numbers of the population might be undiagnosed and at high risk.
In recent years, with the rise of global diabetes expected to reach nearly 700 million by 2035, a growing number of patients are suffering from pain and infections caused by the invasive and frequent nature of using mainstream commercial glucose meters. The most common cutaneous complications are wear-related erythema, itching and induration, but more severe cases, typically related to bacterial infection, continue to grow as well. This has led to the need for noninvasive blood glucose monitoring technology, which could relieve numerous issues that many diabetes patients face.
Noninvasive blood glucose monitoring refers to the detection of human blood glucose without causing damage to human tissues. Many noninvasive blood glucose detection methods can be divided into the optical, microwave and electrochemical processes.
Medical imaging technologies are gaining global relevance in the medical community to assist clinicians in the diagnosis and guiding therapeutic treatment of patients. The big plus is that it's noninvasive and offers high-resolution results. The most common medical imaging technologies are computed tomography, magnetic resonance imaging and ultrasonography.
Noninvasive imaging techniques are used in almost every medical field as a diagnostic tool and to monitor pathological progression or the efficacy of treatments. Several imaging tools are available to provide structural and functional information about tissue and organ physiology. New hybrid devices and multimodal imaging offer opportunities for research and use in clinics.
Companies like General Electric Co. Healthcare, Lantheus Holdings Inc., Varex Imaging Corp. and OSI Systems Inc have invested heavily in medical imaging products, but most are better known for other medical offerings or other industries altogether.
Know Labs Inc., an emerging developer in noninvasive medical diagnostics, focuses on developing its proprietary spectroscopic technologies using the electromagnetic spectrum. The goal is to accurately identify and measure a wide range of organic and inorganic materials, molecules and compositions of matter.
Know Labs’ technology uses spectroscopy to direct electromagnetic energy through a substance or material to capture a unique molecular signature. It refers to its technology as Bio-RFID™, which can be integrated into various wearable, mobile or benchtop devices. The company’s patented and patent-pending technology makes it possible to effectively identify and monitor analyses that could only previously be performed by invasive, expensive and time-consuming lab-based tests.
The first application of its Bio-RFID technology will reportedly be in a product marketed as a noninvasive glucose monitor, giving the user real-time information on blood glucose levels.
Know Labs’ leadership says it's confident it will be the first company to bring an FDA-cleared noninvasive glucose monitoring device to market. Know Labs is conducting a 200-person internal clinical trial of Bio-RFID, which will help the company refine its algorithm and demonstrate Bio-RFID’s accuracy in a large population. Previous internal tests demonstrated Bio-RFID has an accuracy on par or better than currently available solutions, which is an important step towards FDA submission.