This content originally appeared on diaTribe. Republished with permission.

By Andrew Briskin

For years, individuals with diabetes have sought out an accurate solution to measure glucose without the necessity for fingersticks or fluid samples. Here’s a take a look at the most recent in research and development of non-invasive glucose monitoring devices.

During the last 20 years, dozens of corporations worldwide have sought to develop a non-invasive glucose monitor – a sensor that would measure your glucose levels without puncturing the skin or having to insert a tool into the body.

The vast majority of these devices thus far have either didn’t work or haven’t received FDA approval. Nevertheless, researchers have been persistent, and in recent times, have fine-tuned different types of non-invasive monitoring technologies, offering promise that a tool may eventually reach the market.

“There is critical demand for a non-invasive glucose monitor, as most of our patients hate sticking their fingers multiple times every day to envision their blood sugars,” said Dr. Farah Khan, an endocrinologist and Clinical Assistant Professor of Medicine on the University of Washington. “If a non-invasive monitor could in some way be [as accurate as] CGMs currently available, this may be an enormous step forward.”

These sensors could make fingersticks and the necessity to insert a continuous glucose monitor (CGM) a thing of the past. Another benefits include avoiding the pain of a needle, eliminating false readings attributable to contamination by substances on the surface of your hands, and limiting waste from disposable testing supplies akin to test strips or lancets.

Moreover, some non-invasive monitors don’t have any disposable components, which could wipe out recurring costs for testing supplies, only requiring a one-time purchase.

Optical technology within the pipeline

The discussion around monitoring glucose levels without the necessity for blood or other bodily fluids is just not recent. Actually, devices have attempted to make use of various types of optical technology because the Nineties.

Optical technology refers to any method that may discover different substances in a fluid (like blood) based on the interaction of those substances with electromagnetic radiation or light.

Nearly the entire non-invasive glucose monitors currently in development use some type of optical technology to gather glucose measurements.Physicians and scientists have already used optical techniques in lots of areas outside of diabetes. For instance, X-ray machines can create images of broken bones based on how our bones absorb and reflect X-rays otherwise than the encircling bodily tissue. Nearly the entire non-invasive glucose monitors currently in development use some type of optical technology to gather glucose measurements.

While different devices use various kinds of light (some use infrared waves, others radio frequency waves), the essential principle is identical. A monitor shines a beam of sunshine through your skin, which is then reflected and scattered by the glucose in your blood. The sensor then detects signals from the sunshine that’s reflected back. Glucose exhibits a novel reflection pattern that differs from the opposite components of blood; the difference in signals is how the sensor determines your glucose level.

After all, this is far easier said than done. One in all the important thing challenges to developing a non-invasive glucose monitor has been determining the differences between glucose and the opposite components in our blood.

“The glucose signal from an optical sensor is small, and other molecules within the body produce interfering signals which are similar, which known as noise,” said Dr. David Klonoff, Medical Director of the Diabetes Research Institute in San Mateo, California, and editor-in-chief of the Journal of Diabetes Science and Technology. “The ratio of glucose signal to noise is commonly very small and it will probably be difficult to isolate the glucose signal itself.”

Nevertheless, our ability to isolate glucose signals alone has improved.

“Newly-developed artificial intelligence and machine learning algorithms have given us greater computational power to isolate a glucose signal from the noise,” said Klonoff. “We’re getting closer to seeing a commercially viable product emerge, because of improved sensors which are smaller and more accurate.”

There are various degrees of optimism as to when this technology might turn into accurate enough to be utilized in an FDA-approved glucose monitor.

“The FDA has never cleared an optical non-invasive glucose monitor,” said Klonoff. “Nevertheless, I expect that the regulatory requirements for eventual clearance will probably be different than what’s required for currently cleared products that measure glucose within the blood or interstitial fluid.”

Somewhat less optimistically, Khan said she worries that these types of optical technology may not have enough precision or accuracy to assist our patients manage their diabetes.

Other non-invasive technology within the works

Outside of non-invasive optical glucose monitors, several corporations have sought to develop a non-invasive fluid sampling device using bodily fluids akin to saliva, sweat, tears, or vapor out of your breath.

“This could be less invasive than even a minimally invasive technology, as they’d not require inserting a needle or probe into the body,” said Klonoff.

Similar problems with accuracy remain, but there was documented progress on this area.

Who’s currently developing non-invasive glucose monitors?

Although individuals with diabetes proceed to attend for this revolutionary technology to succeed in the market, lots of of tens of millions of dollars in funding for startups across the globe, not to say efforts by larger, more established technology corporations.

Nemaura Medical

This company has developed a tool called sugarBEAT, which has received approval in Europe and has been submitted to the FDA for review within the U.S.

Sitting in your skin like a patch, sugarBEAT is a small device that measures your glucose constantly by running a slight, imperceptible electric current through your skin, which causes glucose to maneuver throughout the interstitial fluid right below your skin.

Early trial data from Nemaura Medical shows that sugarBEAT is very near the accuracy of CGMs currently available available on the market.

DiaMonTech

A biotechnology startup based in Germany, DiaMonTech is currently developing three versions of its non-invasive glucose monitor.

• The D-Base: A desktop device (roughly the dimensions of a shoebox) intended to be used by multiple people in a clinical setting.
• D-Pocket: A hand-held device that matches within the user’s pocket or handbag, on which you press your finger for a glucose measurement.
• D-sensor: An integrated sensor that might be worn as a bracelet.

All three use the identical technology to collect glucose measurements, which the corporate coined “photothermal detection.” The sensor directs a beam of sunshine onto the skin, which warms the glucose molecules in your skin very barely (only around 1/1000 Celsius.) After just a few seconds, the sensor gives a glucose reading based on the absorption and reflection pattern of the sunshine.

While each of those versions is at a unique point within the approval process, there’s evidence that the technology does work and is approaching the accuracy level of CGMs. The three devices are still in development to enhance accuracy, so that they usually are not currently available for purchase.

Apple

The tech giant considered including a non-invasive glucose sensor in the brand new Apple Watch Series 7, which unfortunately didn’t come to fruition.

UK-based startup Rockley Photonics, one among Apple’s previous partners, had released a “clinic-on-the-wrist” health watch. Nevertheless, the partnership has since been discontinued. The technology is kind of similar to that utilized by DiaMonTech and will represent an enormous addition to Apple’s health monitoring features within the near future.

In February 2023, Apple announced that it hit a significant milestone in developing the technology, and has reportedly been working on it since 2009. The corporate has spent lots of of tens of millions of dollars on the hassle and now believes that the technology could eventually be made available to the general public.

Cnoga Medical

Cnoga is a digital healthcare startup based in Israel, which has developed a hybrid non-invasive monitor called the TensorTip Combo Glucometer (CoG). The device is known as “hybrid” since users must calibrate it with each invasive and non-invasive measurements for the primary three days of use.

After calibration, the device is totally non-invasive. Just like other devices, CoG emits a small amount of sunshine through your finger, which you insert into the device. As the sunshine signal is absorbed and reflected by the glucose in your blood, the signal projects onto one other camera and processes the signals using an AI algorithm to supply a glucose value.

CoG is a small, portable device that has received CE clearance in Europe. In accordance with research, the accuracy of the device still lags behind CGMs.

GWave by Hagar

The GWave is a non-invasive glucose monitor created by Hagar, also a startup based in Israel. It uses radio frequency waves to measure blood glucose constantly. This device has currently not received CE clearance or FDA approval.

In March 2023, the corporate announced early results from its ongoing clinical study, which included 20 participants. The study compared GWave readings to fingerstick measurements at various time points, yielding accuracy inside a narrow glucose range (70-140 mg/dL). Hagar plans to start out a bigger clinical trial with 250 participants by the top of 2023 on adults with type 1 or type 2 diabetes in Israel.

Know Labs

This Seattle-based startup has developed two non-invasive glucose sensors, each of which use a patented radio frequency wave technology called Bio-RFID.

• The KnowU: A pocket-size device that measures your glucose on-demand with an easy palm placement on the device.
• The UBand: A continuous monitor that’s worn in your wrist.

While still early in the method, data from early human trials are quite promising. When put next to fingerstick glucose measurements, the Bio-RFID measurements were reported to be well throughout the accuracy standards established by CGMs currently available on the market.

Lassie by BOYDSense

Lassie is a prospective pocket-size device that measures glucose through the breath not directly by measuring other compounds that the body produces from using glucose for energy.

In a presentation on the ATTD 2023 annual conference in Berlin, Bruno Thuillier, founder and chief technology officer of BOYDSense, explained that the corporate is currently working on an algorithm that may calculate glucose levels based on measurements of specific compounds within the breath.

Other non-invasive glucose monitoring projects include:

The underside line

After all, this list is incomplete. These are only just a few of the various startups and biotechnology corporations searching for to develop a non-invasive glucose monitor.

During the last 100 years, we now have progressed from measuring glucose within the urine to blood testing and fingersticks to CGMs. Much has modified in that point, from improving the convenience of taking measurements to expanding our wealth of glucose data with what number of measurements we are able to take every day. Nevertheless, the necessity for blood or other bodily fluids to take a measurement has been constant.

So is it hope or hype? Even though it could seem that regulatory barriers squash any hopes of a non-invasive device reaching the market, the demand, motivation, and money are there to maintain development going.

It would be interesting to look at which of those small corporations gets the eye of one among the large players in diabetes technology; this could possibly be a clue about which device is furthest along. The technology is improving rapidly, nevertheless it could also be several more years before we see a non-invasive device available on the market.