If I took a poll on the one question I have had to answer the most over the past 36 years with diabetes, it’s this one:
“No.” I’ve answered many times. “There are worse things.” I’m not certain why I don’t tell the truth. The exercise of inserting a needle into the tips of my fingers seems very insignificant in the scheme of things. I already have a life-threatening illness – what’s a little pin prick?
But the truth is – it does hurt - and it can sometimes feel like the first second of a bee sting. People with diabetes need to test their blood sugars at least 4-6 + times per day, which means that many of us have had as many as 100,000 tests in a diabetes lifetime. For many patients, especially small children, fingers are just too delicate for the daily rounds of finger-sticking. Others, who have been testing blood sugars for three decades, have thick callouses on their fingers from years of the blood-letting wear and tear. Blood sugar testing is another misunderstood burden in the world of diabetes self-management. Testing is tedious, painful, skin damaging and absolutely necessary for eating, sleeping, exercising, and even for something as mundane as driving a car. In fact, for people who manage diabetes with insulin, testing blood sugar is often the difference between living or not.
Because testing blood sugars is such a fundamental and painful part of diabetes care, I was keen to learn more about a team of Hong Kong scientists and academics working on clinical studies for a Near-infrared (NIR) non-invasive blood glucose meter. Professor Joanne Chung (Hong Kong Institute of Education) and her colleague Professor Thomas Wong (Hong Kong Polytechnic University) have been developing the Near-infrared (NIR) technology since 2004. They have conducted seven clinical studies on more than 800 patients with a high degree of success, and are currently working on their eighth study. Benefits of non-invasive technology to measure blood sugar include a needle-free, pain-less testing system which eliminates possible infection and the high cost of current test strips prescribed today. It would also make millions of patients more relaxed about testing and infinitely more motivated to test.
The Problem of Pain
I met Professor Joanne Chung at the Hong Kong Institute of Education, located in Tai Po in the New Territories of Hong Kong, near the border of mainland China. Before her academic career, Professor Chung spent years working in clinical settings caring for patients in intensive care units and for people with cancer and diabetes in local hospitals and hospices. She quickly became interested in understanding the problem of pain so much so that it became the basis of her PhD work. In fact, Professor Chung continues to run a local pain management clinic in conjunction with her full-time research work on the Near-infrared (NIR) non-invasive blood glucose meter. Having seen such a wide spectrum of patient pain in her earlier clinical days, I wondered why she chose to focus on this aspect of diabetes.
“When you compare the pain of a pin prick to neuropathy, or cancer pain, it is very small, but the problem with blood glucose testing is how patients suffer with it every day. There is no other remedy. It’s impossible to separate the difference between pain and suffering. Professor Wong, myself and the rest of the team wanted to do something about this pain and suffering in diabetes care. It was something like a dream in the beginning.” Professor Chung and the scientific team decided to move forward and outline deliverables for a non-invasive technology, and at first, assessed then current research by traveling to different countries to meet with scientists working in the field and analyzed other models such as the Glucowatch. Then they got to work on their dream.
Near-infrared Technology (NIR)
What is NIR? Near-infrared technology uses light spectrum with different wavelengths to detect blood sugar values and is used traditionally in animal studies for glucose measurements, but these laboratory methods are too dangerous for use on humans. For proprietary reasons, I can’t go into a great deal of detail, but very simply, Professor Chung’s research prototype uses the NIR technology via a spectrometer light source (at a lower safe level) to detect the level of glucose in the blood with a tiny sensor (1/4 of the size of a dime) worn on a patient’s earlobe, forearm or fingertip (and here’s a practical piece of information for finger-sticking patients – the forefinger and the middle finger are the easiest to replicate). Currently the team has succeeded in stabilizing all measurements below 8 mmol/l and above 4.2 mmol/l. (For mg/dl, mutilply these values by 18). For blood sugars between 8 and 12 mmol/l, the research is less stable but still classified as valid or acceptable. Because hypoglycemia is a major concern for all patients, the product is not yet ready for market although some in the industry who are more commercially eager would argue that it is. Has the team been contacted by the pharmaceutical industry or other academic centers? “Yes, we are working on plans for next steps today.” Why are the lower blood sugar readings a problem for the team? Professor Chung doesn’t have the data for the lower readings because out of the 800 subjects she has tested very few patients suffer from hypoglycemia. In other words, Hong Kong cannot provide Professor Chung with an adequate type 1 population for research. All seven studies so far have been conducted on type 2 patients and a very small population of healthy individuals. More studies are needed on type 1 patients, and for that, the research will have to go outside of Hong Kong. (Hong Kong population is 7 million, type 2 population is estimated at 10%; Type 1 population is estimated around .0002).
The only “noninvasive” glucose meter to have received U.S. Food and Drug Administration (FDA) approval was the Glucowatch in 2001 but the product was removed from the market in 2007. The Glucowatch administered a small electrical charge to bring glucose to the surface and read by the watch sensor, but it caused skin irritations, rashes and its overall accuracy was problematic. Today, Echo Therapeutics, a transdermal medical device company based in Franklin, Massachusetts, is developing a wireless, needle-free transdermal continuous glucose monitoring system called Symphony tCGM, described in Scientific American Magazine earlier this year. Like the Glucowatch, the Symphony tCGM passes tiny electric pulses into the skin using a biosensor which detects glucose as it diffuses out through the capillaries. The readings are sent wirelessly to a handheld device. I asked Professor Chung about the the Symphony tCGM, “The preliminary prototype has given promising results,” she told me, but there are issues. “The longevity of the sensor, the accuracy of the device, the transdermal blood glucose variation (in terms of the time lag) and longitudinal adverse outcomes should further be explored.”
Near-infrared (NIR) Non-invasive Blood Glucose Meter’s Future
The NIR non-invasive blood glucose meter’s most promising future lies with the utilization of wireless technology and telehealth systems. Here’s how: individual sensor results from the NIR non-invasive meter would be sent wirelessly to a mainframe system and within seconds the results from the NIR technology would be delivered via SMS mobile messaging to the patient. In this way, the technology could be downloaded by physicians and educators for assessing patient care and record-keeping, making it as competitive as the current CGM system without inserting a subcutaneous sensor. The biggest challenge? The size of the spectrometer is still too large and too costly. With more type 1 subjects, professor Chung will have the ability to shorten the wavelengths and with that advantage, the spectrometer could become the size of a small dial, making it more cost efficient. “We may be 2-3 years away from that. Two-thirds of the work is completed. Our research is ongoing. We’ll get there.”
Confidence is a powerful tool. I believe all people with diabetes are waiting for the day when non-inasive blood sugar testing is less of a dream and more of a reality; with NIR technology, it sounds like we are getting closer.