We seem to be hearing about more and more new approaches to realizing the dream of noninvasive glucose monitoring — a way to test blood sugar without the need to poke your fingers or pierce your skin.
One of the latest making headlines is startup Scanbo based in British Columbia, Canada. Founded in late 2017, this young medtech company is led by Ashissh Raichura, who has a background in IT consulting and entrepreneurship, focused lately on artificial intelligence (AI) software.
As the name suggests, Scanbo’s concept is about scanning your skin. In this case, your fingertips are placed on a small digital pad and the device uses a proprietary algorithm to assess your glucose levels.
The device is still in prototype stage, but is interesting because it takes a different approach than competitors, combining electrocardiogram (ECG) measurement with optical photoplethysmogram (PPG) sensing for the first time to measure blood glucose levels.
“This will be a blessing for prediabetics who are not comfortable poking their fingers multiple times in a day, and do not want to spend money on glucose strips and costly continuous monitoring devices,” Raichura told DiabetesMine.
This is not a wearable device or patch, but is rather more similar to a traditional glucose meter that you buy and have on hand to use as needed. It is a small handheld pad that folds in half, with the fingertip scanning portion on the lower end and the screen showing data results at the top.
To use it, you power on the device and just need to keep two fingers of each hand on the device when you want to check your blood glucose levels. The first prototype model generates results in 60 seconds, but Scanbo is working to reduce that to 30 seconds.
Scanbo uses a chargeable battery, with an expected battery life of 3 years.
It collects data using two different measurements, most often used for monitoring heart rates:
- ECG, which typically uses small, plastic patch electrodes that are stuck to the skin on the chest, arms, and legs and then those electrodes are connected to an ECG machine by lead wires.
- PPG, noninvasive technology that uses a light source and a photo-detector at the surface of skin to measure the volumetric variations of blood circulation.
With the Scanbo glucose monitoring sensor pad, both of those are applied at the same time — rather than sequentially, as is usual. The data is sent to the cloud, where it’s analyzed using the Scanbo AI algorithm to generate a result. The numbers can currently be viewed on the device, and Scanbo is also developing a smartphone app that will display results and also control the device.
The device currently provides an audible reading of your glucose level, and Scanbo plans to introduce voice-guided instructions in the future smartphone app as well.
The company has a provisional patent in the United States Patent and Trademark Office and is planning to extend that to other countries. Scanbo is not yet available in other countries, as the company plans to launch first in the United States.
Scanbo says it is currently raising money to begin clinical trials and apply for an initial 510(k) filing with the Food and Drug Administration (FDA). Should that happen as planned, the company ambitiously hopes to begin the FDA review process by mid-2022.
The company says it’s too early for finalized pricing detail, but one model it’s exploring involves a one-time device payment followed by a monthly subscription for the AI cloud — potentially as low as $20 a month.
The company says another piece of their patent-pending algorithm covers noninvasive blood pressure and heart rate monitoring as well, using an arm cuff attachment.
While Scanbo points to their glucose measurement method as new and innovative, the science behind it has been used for different medtech purposes for many years, largely for heart rate monitoring.
Raichura said, “Scanbo is different as we collect data from PPG red, green, and also ECG data at the same time and not sequential. We use all these processes at the same time on our different… algorithms to generate glucose levels. As it’s based on an AI/machine learning algorithm, we are confident that accuracy will improve over a period of time.”
As of early 2022, Raichura says Scanbo has conducted 248 tests using this technology with “all the gold standard blood glucose meters available.” The results are “very promising,” he says, in the range of 5 to 10 percent of traditional fingerstick glucose meters.
“Sorry, we can’t share the study data link at this stage,” Raichura told DiabetesMine, when asked for any published data on accuracy results.
In a recent TechCrunch article on Scanbo, the author notes that using ECG technology for hyperglycemia (high blood sugar) detection has
However, the author also notes that, “It doesn’t look like the FDA has approved any products that take this approach yet, so the company is certainly facing a lengthy medical approval process in order to bring its products to market.”
The universal question for any proposed noninvasive glucose monitoring technology is whether it will actually materialize into a commercially viable product. Other attempts to create these products have fallen flat through the decades.
The Diabetes Technology Society published a scientific analysis on this topic in October 2021, noting “the amount of interest in seeing the development of an accurate [noninvasive glucose sensor] and the amount of hyperbole by companies promising an accurate [product] both far outstrip the amount of publicly available data actually generated by these potential products.”
Their biggest messages appear to be that “the challenges are substantial to produce a device that provides clinically relevant results” and that “products with only secret, unpublished data will ultimately not be embraced” by the medical, scientific, engineering, regulatory, and business communities.
They call for the publication of data on new noninvasive devices to stimulate new ideas and approaches, and to help establish useful benchmarks in this new field. We hope that companies like Scanbo will be sharing their data publicly soon.
Meanwhile, hope does remain. Many experts believe that noninvasive glucose measuring devices will succeed, and create a booming market in the next 5 years.
We shall see, and it’s to be determined on whether Scanbo has the potential to succeed where so many others have failed.