The Smart Magazine About Medical Technology Innovations
The End of Diabetic Burnout ?
“The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.” (WHO). Such a global epidemic requires not only preventative action, such as healthful diets, but also worldwide innovation to improve diagnosis, treatment and data collection.
In this 28th issue of MedicalExpo e-Magazine, we decided to focus on some of the most promising solutions. These include contact lenses that monitor blood glucose levels and other technologies to ease the burden of life with diabetes for both patients and caregivers.
On a different note, the dental world is currently meeting in Cologne for the IDS tradeshow. Digital workflows, GPS for dentists, dental robots, and more—you’ll find them all in this issue.
Three to five times a day, patients with diabetes have to prick their fingers to draw a drop of blood to determine if their blood glucose levels need to be adjusted.
The demands of the regimen can wear patients down, threatening their compliance with monitoring and, therefore, their health.
“In the diabetes community,...
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.
SugarBeat Courtesy of Nemaura Medical
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.”
Courtesy of Integrity Applications
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.
“By training, I am an engineer. From a precision perspective, the standard impression process is a nightmare: You generate a copy of a copy of the original, and then a technician creates a copy.” Daniel Kaiserauer is the director of CS Solutions, Carestream’s division in charge of dental CAD/CAM restoration and a...
It wouldn’t seem a dentist could get lost in a patient’s mouth during oral surgery. But dentistry is complicated–so it happens.
Doron Dekel, CEO and co-founder of Toronto-based ClaroNav, a pioneering dental navigation company, said, “Many different complications can occur. Dentists, for instance, can hit the roots of nearby teeth, if they are drilling near an existing tooth and the root is angled slightly diagonally. Or the dentist can hit the nerve that goes through the jaw and then can paralyze half the face for six months or permanently.”
ClaroNav developed software and hardware for its Navident system to provide real-time data to dentists to steer clear of these problems. Navident has been on the market in the U.S. since September 2016 and in Canada, Europe and Asia since 2015. The main purchasers of the $25,000 systems are oral and maxillofacial surgeons, high-volume general dentists, prosthodontists and periodontists.
From Neurosurgery to Dentistry
Navident Courtesy of ClaroNav
Before launching ClaroNav in 2010, Dekel and co-founder Claudio Gatti worked for a manufacturer of a neurosurgery navigation system. They decided to apply the idea to dentistry. They came up with a 25-kilogram system on wheels with lighting and an arm holding a laptop linked with data from a CBCT [cone beam CT] scan, a special type of scanner for dentistry.
Navident will tell you where you are on that map
Dekel said Navident is a GPS-like system where a CBCT scan of a patient’s mouth creates a 3-D map of the patient’s anatomy. “When you move instruments in the anatomy, Navident will tell you where you are on that map,” he said.
The dental surgeon plans where implants should be placed in the image. Navident dynamically tracks the drill and the patient’s jaw, providing guidance and visual feedback to ensure the implants are placed according to plan, Dekel said.
During the surgery, the dentist looks at the video monitor on a 13- or 15-inch laptop which magnifies the teeth by a factor of 20 times.
0.5 Millimeters Accuracy
Dekel said dentists using his guidance system have an average accuracy of about 0.5 millimeters compared with 2.5 millimeters for dentists not using a guidance system.
Dentists as well as patients experience major benefits from the system.
“Navident is less invasive than traditional surgery. You don’t have to cut open the gums to expose the bone. Incisions obviously increase the pain and the bleeding and the risk of infection,” said Dekel. “They also increase the time of surgery and put stitches in the mouth which are uncomfortable for the patient.”
You don’t have to cut open the gums to expose the bone.
Enhancements have been added to the system. Dekel said the company’s ClaroScope is a new HD camera enabling the surgeon to zoom in on the area where he or she is working.
Other dental navigation companies include Eped Inc. in Taiwan, X-Nav Technologies in Lansdale, Pennsylvania and Inliant Surgical in Vancouver, Canada.
With 127 millions diabetic adults in China alone—almost a quarter of the global diabetic population—the country’s experience with the diabetes epidemic has become a health disaster.
To begin filling the need for tailored solutions, last year Chinese pharmaceutical giant Hunan China Sun paid $2 million for a 20% stake in Glucovation, a San Diego-based life science SME developing an innovative continuous glucose monitoring (CGM) system for Chinese diabetics.
Following the recent signing of a $12.5 million licensing and development agreement between the two companies, a China-based joint venture began pre-clinical human trials of Glucovation technology in February.
We caught up with Glucovation executive vice president Fernando Corona to discuss the company and its China focus.
MedicalExpo e-Magazine: Can you tell us a little about Glucovation and what the company is currently working on?
Fernando_Corona_Glucovation Courtesy of Glucovation
Fernando Corona: Glucovation was founded in May 2013 by three ex-Dexcom (another California-based CGM company) employees. We are currently developing a minimally invasive, low-cost CGM system that is factory calibrated (no daily finger sticks) for use in price sensitive markets such as China.
Our system uses a micro needle that is painless to insert, and which can be left in the abdomen or an arm for up to 10 days without discomfort. It samples interstitial fluid, in which the level of blood glucose correlates well to that of blood itself. The sensor we’re developing is non-enzymatic—its electrochemical properties achieve performance levels that have never been seen in the CGM space before.
Anyone affected with Type 1, Type 2 or pre-diabetes will be able to monitor their glycemic levels using the device.
ME e-mag: How important is the Chinese market for Glucovation?
Fernando Corona: Very important. China is the second largest diabetic market (with 127 million Type 1 and 2 diabetics) in the world behind India. Dexcom will generate over $550 million in sales in 2017, with most of their revenue based on a diabetic population of just 29 million in the United States. This gives you an idea of the enormous potential of the Chinese market.
ME e-mag: Why partner with a Chinese company?
Fernando Corona: Finding funding for a product like ours was a lot easier outside the United States. Most investment-focused Western companies are looking for technologies that are further along the development process, with a lot of evidential data to support claims.
We also felt that our product needed to be a locally manufactured product specifically targeting the Chinese market. If the product is developed in China and has not entered any regulatory process outside of China, it’s a lot easier to obtain regulatory approval.
ME e-mag: Do you have any advice for other life science SMEs looking to enter the Chinese market?
Fernando Corona: Partner, partner, partner. Make sure you understand the culture and negotiation process, and be patient.
Pressure ulcers are among the most dreaded dangers for diabetics, one caregivers have a hard time fighting. In response, Stryker, StiegelMeyer, ArjoHuntleigh and others offer anti-decubitus mattresses. The Czech company Linet has developed a comprehensive range of such products.
We interviewed Zdenka Chalabalova, clinical coach at Linet, to get an overview of the battle against pressure ulcers.
MedicalExpo e-Magazine: What’s the main risk of pressure ulcers for diabetics?
Zdenka Chalabalova: When a patient has diabetes, it’s particularly important to avoid any kind of foot injury, which can have tragic consequences. Today, there are no mattresses specifically for diabetics, but certain innovations can help.
Our Virtuoso range has four cells in the heel area which can be partially or completely deflated. That decreases the risk of foot injury. The “heel zoner” is currently an option, but we hope to make it standard in the future.
MedicalExpo e-Magazine: What kinds of pressure-control therapies are available for the entire mattress?
Zdenka Chalabalova: There are two main modes—the alternating pressure mode and the constant low-pressure mode. Constant low pressure is the simplest mode. Pressure cells adjust automatically to the patient’s weight thanks to scales built into the bed.
If the patients are comfortable with it, we tend to recommend the alternating pressure mode with a three-cell cycle. Two cells are inflated and one is deflated, so that the patient feels zero pressure in a specific zone. During the 7.5-minute cycle, each cell deflates every 2.5 minutes.
MedicalExpo e-Magazine: Why 7.5 minutes?
Zdenka Chalabalova: Studies show that if you change position on average at least 56 times during the night, you won’t suffer tissue damage. The 7.5-minute cycles alleviate pressure throughout the night.
MedicalExpo e-Magazine: Can you explain the microclimate management in your Symbioso brand?
Zdenka Chalabalova: The microclimate system continuously blows air between the cells. It’s a way to remove moisture and to ensure that the patient’s skin stays as dry as required. Microclimate management is also available in two modes—normal mode and reduced-noise sleep mode. In normal mode, 50 liters of air are pushed under a patient’s body every minute. In sleep mode, this drops to only 38 liters per minute.
MedicalExpo e-Magazine: You also describe your Symbioso brand as intelligent. What does that mean?
Zdenka Chalabalova: These mattresses automatically adjust pressure based on the patient’s weight. This is a major trend in our industry: More and more, mattresses will be able to determine the ideal pressure thanks to scales in the bed.