By the end of the year, patients suffering from a painful gastrointestinal (GI) problem will be able to swallow a vitamin-sized electronic “pill” that can collect data from their bodies and wirelessly send it to a nearby device.
The SmartPill GI Monitoring System, approved for use in July by the U.S. Food and Drug Administration (FDA), is being readied for distribution by Buffalo, N.Y.-based SmartPill Corp. The company hopes to revolutionize the treatment of GI problems among thousands of patients.
Previously, doctors treated patients with or gastroparesis — gastric emptying symptoms — by sending them to a radiologist for tests that lasted four to eight hours and required the use of radioactive isotopes to track a patient’s GI functions, according to Leslie Hornung, a SmartPill spokeswoman. Slow gastric emptying symptoms affect some 50 percent of diabetics, she said, causing sufferers to feel bloated after eating a small amount of food as well as nausea or vomiting.
The SmartPill capsule includes miniaturized sensors, a printed circuit board and tiny batteries that work to collect medical data as it makes its way through a person’s GI tract and transmit it to an external receiver. Once swallowed, the device collects information on pressure, pH and temperature, Hornung said, storing data and transmitting it wirelessly to a PDA-sized receiver that the patient keeps close by during the testing.
After the capsule passes through the patient’s GI tract, it is discarded and a phyician collects the data from the receiver and processes it using a special laptop and proprietary software from SmartPill Corp.
“It changes the entire dynamics of patient management,” said David Barthel, the CEO and president of SmartPill. “People often suffer for years without accurate diagnoses.”
The idea for a GI data collection system began several years ago at the University of Buffalo, he said. In 2003, SmartPill began development and design, followed by clinical trials, he said. The devices are expected to be available to doctors and hospitals by the end of October, he said.
Future versions could eventually help diagnose other GI problems, including irritable bowel syndrome, Barthel said.
The capsules will retail for about US$500, while the computer system and software that evaluate the results will sell for about $20,000, according to the company. Called MotiliGI, the application includes software for the capsules, for the receiver and for data analysis after patient monitoring is completed.
Matt Petersen, a spokesman for the Alexandria, Va.-based American Diabetes Association, said gastroparesis among diabetes patients is “a real problem. It’s certainly under recognized,” compared to more commonly known complications.
“People often suffer with this problem not realizing that it’s related to diabetes,” Petersen said. “It can be painful and uncomfortable. It’s considered a serious complication of diabetes.”
The condition is difficult to diagnose, he said. “An alternative approach to diagnose it, I would assume, would be welcome,” he said.