14 April 2015. A clinical trial is getting under way testing a smartphone app to help people with diabetes manage their condition, and in particular assess chronic foot ulcers associated with diabetes. The application is the work of an information technology and biomedical engineering team at Worcester Polytechnic Institute in Massachusetts, that described the system in an article appearing earlier this year in IEEE Transactions Biomedical Engineering (paid subscription required).
Diabetes is a chronic disorder where the body cannot regulate the amount of glucose or sugar in the blood, affecting more than 29 million Americans, according to Centers for Disease Control and Prevention. Another 86 million people in the U.S., more than 1 in 3 adults, have prediabetes: high blood sugar levels, but not yet reaching full-fledged diabetes.
Among the effects of diabetes is reduced blood flow to the legs and feet, leading to nerve damage and reduced feeling in those regions, as well as slower healing of wounds. CDC says in 2008, some 70,000 Americans required amputation of a leg or foot because of complications from diabetes. In addition, says CDC, people with diabetes are 8 times more likely to lose a leg or foot than people without diabetes.
A team of computer and biomedical engineers at Worcester Tech, led by business IT professor Diane Strong, developed a system to help people with diabetes, especially those with foot ulcers, better manage their conditions. The core of the system is a smartphone app called Sugar designed to keep track of key factors related to diabetes that connects wirelessly to an individual’s blood glucose meter. The app also records the users weight and amount of exercise performed, and based on the data collected, returns messages encouraging different courses of action (e.g., get more exercise), or continued good practices.
Sugar — written so far only in an Android version — has a section devoted to recording the state of an individual’s foot ulcers. The app asks the user to take photos of foot sores with the smartphone’s camera that sends images to a program on a PC for analysis. The individual places his or her foot in a box that illuminates the foot and captures the image.
The analytical program converts the image to a bit-mapped format, then runs a series of algorithms to assess the size and healing status of the wound, which are tracked over time. Tests of the wound analysis module over 12 months, reported in the journal article, show the technique can accurately monitor the status of diabetic foot ulcers.
Peder Pedersen, professor of computer engineering at Worcester Tech who led development of the wound analysis section of the app says in a university statement, “For the first time, this system will give patients the ability to play an active role in their wound care.”
The clinical trial will be an early pilot test of Sugar. The trial at nearby University of Massachusetts Medical School plans to enroll 30 patients with foot ulcers at the medical center’s wound clinic. Participants will be randomly assigned to use Sugar for 6 weeks, covering a period of 3 visits to the clinic, or receive the usual standard of care. The trial will measure wound care progress and changes in healthy lifestyle over the test period.
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