Automated Home Monitor Effective for the Early Detection of Diabetic Foot Ulcer
About 86% of participants used the monitor more than 3 times per week on average.
NEW ORLEANS – A new automated home monitor may significantly reduce diabetic foot ulcer-related morbidity, mortality, and resource utilization, according to a prospective, multicenter study presented at the American Diabetes Association's 76th Scientific Sessions. Investigators conducted a study with high-risk diabetic patients and found this monitor is very simple to use and patients may receive a myriad of benefits.
“This is not the first study on temperature assessments as early indicators of potential plantar ulceration,” said study investigator Robert Frykberg, MD, who specializes in podiatric medicine and is affiliated with Banner Good Samaritan Medical Center and Carl T. Hayden VA Medical Center in Phoenix, Arizona.
“However, it is the first to incorporate a thermometric mat on which a patient can stand each day to assess temperature asymmetry. Uniquely, the ‘smart' mat connects with a cloud-based central monitoring server from which temperatures are read.”
Dr Frykberg, who presented the study findings at the meeting, said asymmetries of 2.2 degrees centigrade or greater that occur in 2 successive days register an alert to the system. This can then be transmitted to the patient or clinician for appropriate follow-up. For the purposes of this non-intervention study, the researchers only recorded temperatures for the purpose of developing sensitivities and specificities for predicting subsequent ulceration.
“Previous randomized controlled trials (RCTs) have confirmed an average of 70% reductions in recurrent foot ulcers as compared to standard of care patients who did not use temperature assessments. Furthermore, several recent practice guidelines and reviews have suggested that temperature assessments be incorporated into daily self-care regimens for high risk patients,” Dr Frykberg told Endocrinology Advisor.
He said monitoring plantar foot temperatures in order to prompt timely pressure offloading has been effective for preventing diabetic foot ulcers. Dr Frykberg and his team completed a prospective, multicenter cohort study in 129 high-risk diabetic patients and followed each patient for 34 weeks. To be enrolled in the study, patients had to have a history of plantar diabetic foot ulcers and have an absence of active foot pathology.
For this investigation, all the patients were instructed to use an in-home, telemedicine, temperature-monitoring mat once daily. The investigators analyzed the ability to predict the development of plantar diabetic foot ulcers and the compliance rate of the mat. With this automated home monitor, prediction of the development of plantar diabetic foot ulcers is based on the temperature asymmetry between the left foot and right foot at 6 plantar locations.
Dr Frykberg and his team examined the sensitivity, specificity, and lead time of the model's predictions for 4 different temperature asymmetry thresholds. They found that a total of 53 non-acute plantar diabetic foot ulcers occurred in 37 patients (0.63 diabetic foot ulcers/subject/year). They were pleased to see that this system could predict a significant number of non-acute plantar diabetic foot ulcers 5 weeks on average prior to clinical presentation.
“Use of the system may significantly reduce diabetic foot ulcer-related morbidity, mortality, and resource utilization. Level 1 evidence has supported this improvement in outcomes and our new device has shown that we can predict the development of ulcers with 97% sensitivity approximately 5 weeks in advance of occurrence” said Dr Frykberg. “We also found that patient adherence was high, with most patients using the device at least 3 or more days per week.”
Overall, the study showed that approximately 86% of subjects used the mat more than 3 times per week on average.
- Frykberg RG, Rothenberg GM, Fitzgerald RH, et al. Abstract 141-OR/141. An automated home monitor for the early detection of diabetic foot ulcers. Presented at: ADA 76th Scientific Sessions; June 10-14, 2016; New Orleans, LA.