Joseph Cafazzo, a biomedical engineer at the University Health Network, in Toronto, and collaborators have developed apps that do much more. Their apps interface wirelessly with medical devices—including a blood-pressure monitor and a blood-sugar monitor—and offer suggestions based on the readings. They found that people using the programs lowered their blood pressure and were more vigilant about monitoring and testing their blood sugar.
One of the most interesting findings was that doctors seemed to play no role in the change. "It was solely patients becoming responsible for their own care," says Cafazzo, who heads the university's Centre for Global eHealth Innovation.
In a yearlong clinical trial of the system involving 110 patients with diabetic hypertension, Cafazzo and colleagues had some people use the app and a home blood-pressure monitor, while others used only a monitor. Those who used the app had a drop in systolic blood pressure of 10 millimeters of mercury, on average, which would reduce the risk of cardiac events by about 25 percent. Those who used just the conventional pressure monitor saw no reduction in blood pressure.
Cafazzo hopes self-monitoring tools like these will be instrumental in changing how chronic conditions, such as diabetes and hypertension, are managed. These conditions represent a huge financial burden on health-care systems. "Primary care isn't the best place for chronic disease management," says Cafazzo. "It should go back to nurses and the patients themselves."
For both apps, researchers won approval from Health Canada (similar to the U.S. Food and Drug Administration) to run the clinical trials. As smart-phone apps become increasingly sophisticated, incorporating external sensors and intelligence to make recommendations to users, this type of approval will become more and more important. Cafazzo says they spent more money running the clinical trial than on developing the technology.
In July, the FDA announced its intentions to regulate smart-phone apps that are used as an accessory to a medical device already regulated by the FDA, or that use attachments, sensors, or other devices to transform the phone into a medical device.
Cafazzo's team plans to create a similar app for kids with asthma. He also hopes to collaborate with a company to commercialize the two existing apps. A limited version of the diabetes-monitoring app is currently available in the Apple app store; it doesn't include automated blood-sugar monitoring but encourages users to test themselves regularly.
2. Automating the collection and processing of medical information is an huge opportunity for hospitals and software companies. The U.S. medical establishment has yet to universalize even simple look-ups, such as what drugs a patient is taking, and has only begun to harness such phenomena as cell-phone apps and Web 2.0 trends like crowd sourcing to improve health care.
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