NEW ORLEANS – Patients with diabetes and peripheral neuropathy who used a smart watch and specially designed smart insoles equipped with an alert system minimized their reulceration risk, results from a proof-of-concept study demonstrated.
The findings suggest that mobile health “could be an effective method to educate patients to change their harmful activity behavior, could enhance adherence to regularly inspect their feet and seek for care in a timely manner, and ultimately may assist in prevention of recurrence of ulcers,” lead author Bijan Najafi, Ph.D., said in an interview in advance of the annual scientific sessions of the American Diabetes Association.
Dr. Najafi, professor of surgery at Baylor College of Medicine, Houston, said that in 2015, approximately one-third of all diabetes-related costs in the United States were spent on diabetic foot ulcers (DFUs). “Unfortunately, many DFUs end up in amputation, which could devastate patients and their families,” he said. “On the same note, persons within the lowest income brackets are estimated to have 38% higher amputation rate, compared with those in the highest income bracket. All these highlight an important gap in effective management of DFUs, in particular among poor working-class people.”
He also noted that DFU recurrence rates are 30%-40% in the first year, compared with 7.5% annual incidence for patients with peripheral neuropathy and no ulcer history. “The good news is that 75% of recurrent foot ulcers are preventable,” said Dr. Najafi, who is also director of clinical research in Baylor’s division of vascular surgery and endovascular therapy and director of the Interdisciplinary Consortium on Advanced Motion Performance. “An effective method is empowering patients to take care of their own health via regular self-inspection of their feet as well as providing timely and personalized foot care. The big challenge is adherence to prevention and regular foot inspection.”
In a study supported in part by Orpyx Medical Technologies, the investigators used a smart watch and smart insoles to enhance adherence to footwear and effective offloading by providing real-time feedback to 19 patients at high risk of DFUs about a harmful plantar pressure event. The patients wore the insole system for 3 months and were alerted through a smart watch if their plantar pressure exceeded 50 mm Hg over 95% of a moving 15-minute window. A successful response to an alert was recorded when offloading occurred within 20 minutes.
Dr. Najafi reported that by the third month, patients who received a higher number of alerts were more likely to use devices and technique to offload weight from their foot, compared with those who received a lower number of alerts (55% vs. 17%, respectively; P less than .01). In addition, patients whose wear time increased during the study tended to have more alerts, compared with other participants (a mean of .82 vs. .36 alerts per hour; P = .09). The best results occurred when patients received at least one alert every 2 hours. “We found that those who frequently received alerts about harmful plantar pressure events improved their adherence to the prescribed footwear and were more responsive to alerts,” he said. At the same time, those patients who received fewer alerts per day, “started to neglect alerts and adherence to footwear over time, despite having initially good adherence at the first month.”
Going forward, Dr. Najafi said, a key challenge is to continue engaging patients to use such technologies on a daily basis. “This could be addressable by providing frequent and comprehensive alerts which not only address harmful plantar pressure during walking but also any harmful foot-loading conditions, including prolonged harmful foot-loading pressure during standing as well as sitting,” he said.
In a video interview at the meeting, Dr. Najafi discussed the study and the challenges of encouraging treatment adherence.
Orpyx Medical Technologies provided partial funding support for the study. Dr. Najafi reported having no financial disclosures. The other authors of this study are Eyal Ron, Ana Enriquez, Ivan Marin, Jacqueline Lee-Eng, Javad Razjouyan, Ph.D., and Dr. David Armstrong. All subjects were recruited at the University of Arizona, College of Medicine, Tucson.