With diabetes now a global health issue of epidemic proportions, the need for better blood glucose monitoring techniques is more urgent than ever. Yet the typically invasive nature of monitoring, which involves finger pricks, tests strips and portable blood glucose meters, has caused problems.
Both type 1 and type 2 diabetics must monitor blood glucose regularly. This can involve 10 or more finger prick tests each day, although studies have shown that many diabetics avoid such tests completely, largely due to the pain and inconvenience.
In recent years the availability of continuous glucose monitoring (CGM) devices, which analyze interstitial fluid glucose levels in real time via subcutaneous sensors, has helped some diabetics reduce the frequency of finger-stick testing (the Dexcom G5 system, for example, requires two daily sticks). To some degree, however, the devices remain invasive.
Today, after years of false starts, the prospect of pain-free glucose monitoring may finally be at hand. With a whole host of non-invasive glucose monitoring (NIGM) devices now under development—many on the verge of market entry—diabetics will be eagerly scrutinizing their pros and cons.
NIGM devices monitor glucose levels without compromising the skin barrier. They either provide continuous readings similar to CGM devices, or intermittent readings where the wearer has to perform some kind of manual test.
A recent report by the University of Birmingham identified 40 new and emerging NIGM technologies, using optical, transdermal or electrochemical techniques. Potential sites for glucose testing included skin, tear fluid, saliva and breath.
Following regulatory (CE) approval, U.K.-based Nemaura Medical plans to introduce its SugarBEAT continuous NIGM system to markets in Europe, Asia and the Middle East in 2017. A self-applied system, it relies on a daily disposable patch to draw interstitial fluid to the surface of the skin via weak electric currrents. Fluid in the patch “reservoir” is then analyzed for glucose by a reusable, electronic sensor.
With SugarBEAT’s sensor activating every five minutes, data is sent to a smartphone, smartwatch or stand-alone reader by Bluetooth for processing. From here it can easily be forwarded to medical professionals. The system requires one daily finger-stick test for calibration, and provides audible alerts.
Due to the lag time between changes in plasma and interstitial glucose levels, CGM systems (both invasive and non-invasive) are less accurate than the finger stick technique. Invasive measurement systems typically use MARD (mean absolute relative deviation) as a measure of accuracy.
Dexcom’s G5, which has a MARD of less than 10%, is generally considered the benchmark for CGM accuracy. By way of comparison, SugarBEAT’s MARD ranged from 14% to 18% in recent trials.
One of our primary goals has always been affordability
“This is deemed adequate for its intended use, since a confirmatory finger prick is still required when therapy decisions need to be made,” says Nemaura Medical CEO Dr. Faz Chowdhury. “Going forward, improved SugarBEAT sensor performance should see MARD continue to fall.”
While no price point has yet been announced, Chowdhury claims SugarBEAT will be the cheapest CGM on the market, with disposable patches costing a few dollars each.
“One of our primary goals has always been affordability,” he says.
Going one step further on the finger prick reduction front is GlucoTrack. A non-continuous NIGM system from Israeli firm Integrity Applications, it only requires six finger stick tests per year.
With widespread market entry in 2016, GlucoTrack has already gained regulatory approval in Europe and South Korea, and is working toward approval in the U.S. and China. The company claims accuracy is “equivalent or better than that of other commercially available CGM systems.”
GlucoTrack uses an earlobe clip-on sensor similar to a pulse oximeter to analyze glucose levels through the skin, using ultrasound, electromagnetic and thermal technologies. The abundance of capillaries and relatively slow blood flow in the earlobe apparently helps to give more accurate readings than at other body testing sites.
GlucoTrack is the only truly non-invasive device available in the world
“GlucoTrack is the only truly non-invasive device available in the world,” claims Integrity CEO Avner Gal. “It is also the only device that combines multiple sensors and technologies to increase reliability.”
Readings from GlucoTrack’s clip-on sensor are transferred via cable to a smartphone-sized “module” that calculates glucose levels. Processed data can then be downloaded for professional analysis (wireless functionality for the module is now under development). While the sensor has to be calibrated every six months with three finger pricks (carried out at the point of sale or in a clinic), it can be used as often as required, and readings take less than a minute.
First-year costs for the latest GlucoTrack model are around $2,100, including one replaceable sensor. This compares favorably with current prices for Dexcom’s G5 (including transmitters and sensors).
With the demand for affordable, practical, accurate and painless glucose monitoring devices at an all-time high, SugarBEAT and GlucoTrack are just two of the many NIGM devices currently making waves. If these devices can be shown to improve glycemic control, then finger prick testing may one day become a pain of the past.
Learn more on continuous blood glucose meters on MedicalExpo.