Advancements in medical technology have paved the way for innovative solutions to monitor blood glucose levels in patients with diabetes. Know Labs, a leading player in the field, has made significant progress in developing a non-invasive blood glucose monitor that aims to replace the painful finger-sticking methods commonly used today. In this article, we will delve into Know Labs' latest developments, including the unveiling of their Generation 1 (Gen 1) prototype and the encouraging results of their algorithm for a needle-free glucose monitoring system.
Generation 1 Prototype: A Game Changer
Know Labs' non-invasive blood glucose monitor has undergone a remarkable transformation with the introduction of the Generation 1 prototype. Unlike the previous KnowU device, the Gen 1 prototype resembles a mouse that fits comfortably in the palm, boasting portability as one of its key features. This design shift is intended to enhance user convenience and mobility.
Bio-RFID Technology: The Key to Non-Invasive Monitoring
At the heart of the Gen 1 prototype lies Know Labs' proprietary Bio-RFID sensing technology. This cutting-edge approach harnesses the power of radio frequencies to detect molecular signatures in the user's tissue without the need for any invasive procedures. The utilization of radio frequencies makes it possible to measure blood glucose levels without causing pain or scarring, a welcome departure from traditional methods.
Promising Results: A Step Forward in Glucose Monitoring
The ultimate goal of Know Labs is to gain FDA clearance and make the Gen 1 non-invasive glucose monitor commercially available to millions of individuals worldwide living with diabetes. Encouragingly, the preliminary results from a recent study highlight the potential of their algorithm to deliver accurate and reliable blood glucose readings.
The Mean Absolute Relative Difference (MARD) Metric
One of the essential metrics for evaluating the performance of a glucose monitor is the Mean Absolute Relative Difference (MARD). MARD quantifies the overall accuracy of the device's measurements by comparing them to a reference method, typically a lab test or an established glucose monitoring system.
Industry Standards and Performance Benchmarks
Continuous glucose monitors (CGMs) with MARD values below 10% are generally considered good, as this level of accuracy ensures reliable glucose readings for patients. Notably, devices like Abbott's Freestyle Libre 3 have achieved an impressive MARD figure of below 7.9%.
Know Labs' Algorithm: A Competitive Edge
In the context of non-invasive glucose monitors, achieving a satisfactory MARD value is particularly challenging due to the complexity of extracting accurate glucose data without direct contact with the bloodstream. Know Labs' algorithm, however, has demonstrated its potential by delivering an overall MARD of 11.3% in the study, with a Dexcom G6 CGM used as the reference system.
Comparison with Established CGM
The Dexcom G6 CGM is a widely used and well-established continuous glucose monitoring system. However, it involves the insertion of a sensor, which can be painful for some patients. In contrast, Know Labs' non-invasive Gen 1 prototype offers comparable results to the Dexcom G6 while avoiding the discomfort associated with sensor insertion.
Implications for Diabetes Management
The availability of a non-invasive blood glucose monitor with satisfactory accuracy is a significant breakthrough for diabetes management. It allows patients to monitor their glucose levels regularly and painlessly, enabling better control over their condition and potentially reducing the risk of complications.
Future Prospects and Challenges
Know Labs is currently conducting further testing for the Gen 1 device, with a strong focus on achieving FDA clearance. Once the regulatory approval is obtained, the device can be made available for commercial use, benefiting millions of people worldwide with diabetes. However, the journey from prototype to market may involve additional challenges, including fine-tuning the algorithm's accuracy and ensuring the device's reliability under various conditions.
Conclusion
Know Labs has made commendable progress with its Generation 1 non-invasive glucose monitor, incorporating Bio-RFID technology and showcasing promising results in the study. While the overall MARD of 11.3% is a significant achievement for a non-invasive solution, the company aims to continue refining its algorithm to improve accuracy further. If successful, the Gen 1 glucose monitor could revolutionize diabetes management by providing pain-free and reliable glucose monitoring for individuals living with diabetes, ultimately contributing to better health outcomes and improved quality of life.
