HERSHEY, PA -- For the millions of people who suffer with diabetes and must prick their fingers several times a day for a blood sample to measure their glucose levels, there may be a new and painless way to take such a measurement using ultrasound.
"This method involves no needles and is completely painless. We think this will eventually make it easier for people to monitor their glucose levels," explains Robert Gabbay, M.D., Ph.D., assistant professor of medicine at Penn State's College of Medicine. "We know that by self-monitoring the disease, and keeping glucose levels at a safe level, individuals can greatly reduce their chance of the disease giving them additional complications such as blindness or kidney failure."
Gabbay and his colleagues' paper titled, "Transdermal Monitoring of Glucose and Other Analytes Using Ultrasound," is published in the March issue of the journal Nature Medicine.
In the paper Gabbay and his colleagues describe the procedure first tested in animals and then in a clinical trial of patients with type 1 diabetes. Low frequency ultrasound, about the same amount a dentist might use to clean teeth, is used to make the skin permeable so that glucose can cross the skin and be measured. Normally, the stratum corneum -- dead layer of outside skin -- provides a barrier to prevent things from crossing the skin. In the trial, however, a single burst of ultrasound lasting less than two minutes is applied to the surface of the skin. The back of the forearm was used because it generally had less hair to interfere with the test. After that, glucose could diffuse across the skin and be measured continuously for the next 12 hours.
"We took blood from one arm of the patients to just be sure our new method had the correct results. Both methods had almost the identical readings," stated Gabbay.
"We used patients with type 1 diabetes because they are dependent on insulin for the rest of their lives and must keep a close watch on their levels," said Gabbay. He also stated, "All were tested using an ultrasound machine that would typically be found in a research lab or hospital. A new hand-held device has been developed so patients could ultimately do the test at home. We hope that by developing this new pain-less method for measuring blood glucose we can help patients achieve better glucose control"
Gabbay says the next step is trying the new method with a larger clinical trial. He estimates that will happen later this year.
The American Diabetes Association (ADA) estimates there are nearly 16 million people in the United States with diabetes or about 6 percent of the population. The ADA estimates just over 10 million people know they have the disease while about 5.5 million are unaware of the disease. Diabetes is the leading cause of blindness in people ages 20 to 70 and is the sixth leading cause of death in the United States. The disease often leads to other complications such as kidney, nerve and heart diseases and stroke. It is the leading cause for non-traumatic amputations and kidney failure. Several large studies have shown that by reducing blood glucose levels with insulin and frequent monitoring of blood glucose, the risk of these complications can be substantially reduced.
Gabbay's work is supported by research grants from the American Diabetes Association, Juvenile Diabetes Foundation and the National Institutes of Health.
Journal
Nature Medicine