What if there were a continuous glucose monitor (CGM) that -- wait for it -- didn't require any needles or puncture your skin at all?
SugarBEAT is a skin patch unlike any other CGM on the market. According to the company, it works by "passing a mild, non-perceptible electric current across the skin, (which) draws a small amount of selected molecules, such as glucose, into a patch placed on the skin. These molecules are drawn out of the interstitial fluid which naturally sits just below the top layer of skin."
In other words, it seems that Nemaura has cracked the code on "
SugarBEAT already has regulatory approval in Europe and the company is preparing for initial launch in the UK and Germany. It's also currently being evaluated by the FDA (submitted in July 2019) and if approved in the next few months, SugarBEAT could be on track for an early 2020 launch here in the U.S.
SugarBEAT CGM specs
Here are the details on the SugarBEAT system and use:
- It's a small "peel and place" patch that sticks onto your skin for 24 hours before needing replacement. The adhesive-backed rectangular transmitter sends wireless readings to a companion smartphone app via Bluetooth every 5 minutes.
- It uses a "gentile, silicon-based" hypo-allergenic adhesive that will supposedly eliminate / cut down skin irritation or insertion problems experienced with CGM use.
- Current approval is for sensor wear on the upper arm (like Eversense) and it's TBD whether regulators will give the official OK for wear on other parts of the body like the abdomen, etc.
- The transmitter is not disposable but rechargeable, though Nemaura hasn't shared how long the battery charge will last, or whether you can charge it during use. The company says the transmitter could last a year or two; the projected shelf-life isn't yet clear.
- It has an average sensor warm-up period of 25 minutes, which would be the shortest warmup time of any CGM on the market.
- The app shows an absolute glucose reading as well as predictive readings up to 20 minutes in advance, with alarms to alert the user before any Low or High actually occurs. SugarBEAT also displays a glucose trend line, like other CGMs.
- The mobile app will also allow other manual inputs such as food, medicine, and exercise, to help users observe how all those factors are impacting their glucose levels.
- The system may or may not require one fingerstick calibration per day; that's up to the FDA, as well as whether it would receive an
"iCGM" designationallowing for interoperability with other devices (something Dexcom G6 currently has).
- The company says they're initially aiming for approval for use in patients 18 and older. They will likely have to submit further study data to seek pediatric use approval at a later time with a Gen 2 product.
- Inserter -- there is none! Remember, it's non-invasive!
Watch a video here that shows how the transmitter is adhered to the skin, and a little about how the app works.
Accuracy and cost
The latest clinical study results presented in September 2019 at the big EASD conference in Spain show that SugarBEAT has a MARD (Mean Absolute Relative Deviation -- measure of CGM accuracy) of 12.4% with one fingerstick calibration per day and 11.92% with two calibrations. Keep in mind that the lower the MARD score, the greater the accuracy. However, EASD study did not publish the accuracy data associated with the important low blood sugar zone of <80 mg/dL. In this January 2018 presentation, SugarBEAT’s MARD was 19.28% in the 61-80 mg/dL range, and 26.92% in the 40-60 mg/dL range.
By comparson, the current Dexcom G6 system has a 9.2% accuracy level without any required fingerstick calibrations. The Dexcom accuracy is also considerably better than SugarBEAT in the <80 mg/dL range. And SugarBEAT's score falls short of the other competing CGM products on the market, too: Medtronic Guardian, Abbott Libre, and the implantable Senseonics Eversense CGM that all come in between 9-10%. They do expect accuracy to improve as the product matures.
Meanwhile, Nemaura is predicting that its system may cost less than one-fifth of competing products:
- $30 per month annual subscription plan for non-insulin users -- includes 8 patches/month, transmitter and recharger
- $55 per month annual subscription for insulin users -- includes 16 patches/month, transmitter and recharger
"This will be the first time such affordable monitoring will be introduced to the market, which we anticipate will broaden further the user uptake, building on the huge success that we have seen the likes of Abbott achieve, allowing more patients to be empowered with CGM data," Nemaura CEO Dr. Faz Chowdhury told us.
Winning at glucose measurement without needles?
You may have noticed that we put the claim "world's first non-invasive glucose monitor" in quotes here. That's because many others have tried this in various forms -- from measuring infrared light to sweat to those Google-backed contact lenses that went bust. There was also the infamous GlucoWatch, approved by the FDA in 2001, that ended up being totally unreliable, while also burning patients' skin (!)
So how does Nemaura believe it has conquered the many challenges with its new SugarBEAT system?
The magic is apparently in its patented SugarBEAT glucose-sensing algorithm that "utilizes an ultra-sensitive glucose oxidase-based sensor to detect actual glucose concentrations, which are then processed by the algorithm on the mobile application."
The details of this proprietary technology seem highly guarded, but we did find one Wall Street Brief that states:
"One of the techniques utilized in these devices is reverse Ionotophoresis, (a type of electrical stimulation used to administer medicine to the body via the skin) which has been the subject of extensive studies with over 20 clinical studies. This technique has been approved by both the FDA and EMEA (European Medicines Evaluation Agency)."
"Nemaura Medical SugarBEAT devices appear to be effective in blood sugar tracking and aiding in better glycemic control through lifestyle management. The company sees potential for expanding the indications... into additional areas such as monitoring of other diseases, lactic acid levels for sports management, and the monitoring of drugs for clinical purposes."
The company is touting competitive advantages like affordability; the comfortable, hypo-allergenic adhesive; and flexible wear -- SugarBEAT can be worn for a single day at a time, with no commitment to wear the device continuously for 10-14 days as is the case with other CGM.
In fact, they're tossing around phrases like "ground-breaking" and "game-changing" and talking up the potential multi-billion-dollar market opportunity.
Maybe so. SugarBEAT certainly appears to be a strong contender to win in this space.
Other systems under development for non-invasive glucose measuring include:
DiaMonTech- Out of Germany, DiaMonTech is a solution that uses molecular spectroscopy – the study of the absorption of light by molecules -- to detect glucose molecules through the skin. They are currently working on a portable pocket glucometer, and hope to introduce a wrist watch CGM device by 2021.
Glucosense - Laser technology to monitor glucose levels under development by a spin-out startup from the University of Leeds, UK. The Glucosense device is made of a nano-engineered glass that fluoresces when stimulated by a low power laser. When the glass is in contact with the user’s finger skin, the reflected fluorescent signal changes based on the concentration of glucose in their blood, giving a measurement in less than 30 seconds.
GlucoTrack - From Israel-based Integrity Applications, GlucoTrack is a device for "intermittent" use that measures blood sugar levels through a sensor that's clipped onto the ear, which is attached to a main glucose monitor. It uses a combination of ultrasonic, electromagnetic and thermal waves to take readings. It appears to be in use already by doctors working with adult type 2 patients.
GlucoWise - From UK-based MediWise, GlucoWise is a hand-held sensor that takes readings on the skin between the thumb and forefinger. It uses radio waves to measure glucose levels that are beamed to a smartphone app. It is currently in early clinical trials.
NovioSense - A Dutch startup working on a glucose sensor that is placed under the lower eyelid, from where it can wirelessly send glucose measurements directly to a smartphone. The NovioSense device consists of a flexible metal coil just 2cm long that contains nanosensors inside. The coil is covered by a protective layer of soft hydrogel, and could measure constant changes in glucose levels from tear fluid using the same enzyme technology employed in conventional glucose test strips. The company announced Phase II clinical trial results in October 2018.