Medical Device Daily Associate

The radiofrequency identification (RFID) business of Digital Angel (South St. Paul, Minnesota) took an interesting new turn when it reported last week that it has been granted a U.S. patent to develop an implantable microchip targeted to improving the way those with diabetes monitor their glucose levels.

This new RFID microchip will measure the glucose concentration levels of diabetic patients and will be marketed and distributed by Digital Angel’s sister company, VeriChip (Delray Beach, Florida).

While Kevin McGrath, president/CEO of Digital Angel, noted that this patent represents a new direction for the company’s RFID technology — which has before now been used primarily for medical identification in humans — he told Medical Device Daily that the new direction is a “natural progression.”

“We sort of telegraphed people along the way that this was logically where we were going to go,” McGrath said.

If successfully developed, this new glucose RFID chip could potentially become a big revenue producer for the company, particularly since checking blood glucose levels regularly is critical to properly managing diabetes and the conventional method for measuring it — a finger prick, commonly called a fingerstick — is invasive, painful and often inaccurate.

Currently, McGrath noted, between 10 million and 13 million in the U.S. use this fingerstick method to monitor their glucose. He said that those people are the ones who are reasonably faithful in monitoring their glucose levels, and they represent only the tip of a very large iceberg.

“The argument is there are probably 30 million people [in the U.S.] who should” monitor their glucose levels. Worldwide, the company estimated that such a product could serve nearly 230 million people with diabetes.

McGrath said that there are two problems with the old fingerstick method. “One,” he said, “it is actually painful, and two, people do it when it’s convenient, not when they should.”

He said that doctors have told him that they would like a system that could easily measure glucose levels at specific times of the day, particularly before and after meals.

The implantable bio-sensor chip has a passive transponder, glucose sensor and integrated circuitry that allow anyone implanted with the microchip to painlessly scan it to determine their level of glucose concentration. The RFID microchip is designed to quickly and accurately transmit the glucose data back to a wireless scanner that displays the glucose level. The RFID microchip is powered by the scanner signal, avoiding the need for a battery in the microchip, and the company said it expects the chip to last at least six months in the body.

The company expects to have a working model of the glucose chip available for clinical trials in about a year, according to McGrath.

Asked about the possibility of such a microchip being incorporated into an implantable glucosepump — such a closed-loop system being the Holy Grail of diabetes care — McGrath allowed that could happen in the future. But he said that for now the company is approaching the development of the chip via “baby steps.”

“The first thing for it to be determining is glucose levels and monitoring glucose levels,” he said. “Now if it’s tied directly to an insulin pump, then there is a whole additional degree of safety concerns that the FDA is going to expect. If it works extraordinarily well, and it’s very reliable, we could see it integrated at some stage with an insulin pump.”

“We recognize that extensive work is required to commercialize this product, including the time and investment required for development, clinical trials and FDA approval,” said McGrath. “Still, we view this as an incredibly important advancement in the world of diabetes management.”

That view was echoed by Joseph Feldman, MD, chairman of the Emergency/Trauma Department of Hackensack University Medical Center (Hackensack, New Jersey). “This is a landmark development in the world of diabetes management,” who called the company’s effort “a landmark development” and especially valuable for “the young and the elderly.”

“By having this technology, the process [of checking glucose levels] becomes effortless. This glucose-sensing RFID microchip is the next great step in implantable microchip technology.”

Digital Angel, which also produces electronic tags for livestock, pets and fish, foresees expansion beyond the human market for the glucose-sensing RFID microchip. According to the company, diabetes is a major disease issue in animal livestock today. As a result, the glucose-sensing RFID microchip could have an equally significant impact in monitoring the glucose levels in livestock animals.

The company also sees other potential uses for the product in humans in other areas where monitoring would be useful. For example, McGrath said a chip could be developed that could monitor the chemical markers that precede heart attacks. This sensor technology, he said, “could give patients a little advance warning [about a heart attack] and that advance warning could mean the difference between life and death.”

Digital Angel is seeking international patent protection covering the same glucose-sensor RFID technology. The company, in conjunction with Verity, its exclusive licensee in the area of human implantable identification products, is in the process of naming the product.

The patent, No. 7,125,382 and titled “Embedded Bio-Sensor System,” was granted on Oct. 24.