One of the elusive holy grails of health tech is a non-invasive measurement of blood glucose levels. We’ve been writing about developments in this field since at least 2015, but we still do not have an FDA-cleared solution. Unfortunately, the general media is quick to jump on the slightest news and publish breathless reports about developments that are certain to change the world.
Many companies and researchers are studying techniques including photoplethysmography (PPG), electrophoresis to draw out interstitial fluid, and even radio frequency (RF) sensors. During CES 2022, I had the opportunity to get a briefing on the latest progress by Quantum Operation, a Japanese company that has received a fair amount of media attention. According to their CES press release, the company was going to “present the world’s first noninvasive glucometer in the form of a wristband that is capable of nonstop monitoring.” That certainly would be an exciting development.
According to the company representative, the results to date were based on non-diabetic volunteers selected from within the company. While there is a prototype that uses PPG (relying on multiple wavelengths), the company is hoping to have a proof of concept device ready by the end of the first quarter of 2022. At this point, they believe that they can measure the difference in levels before and after a meal. Still, the device may require calibration with a finger stick.
The initial plan is to develop a product just for the Japanese market, and they might choose not to pursue clearance as a medical device at this time. Instead, they might market it as a health device that reports the relative change in levels rather than absolute glucose levels. The representative said that such a device might reach the market in the third quarter of 2022.
While this would qualify as continuous monitoring of blood glucose levels, it’s not clear that this will provide information that can be used to make medical decisions such as insulin dosages. As a result, we expect that we’re going to have to wait a bit longer before we have a replacement for finger sticks and CGMs for diabetic patients.