JMIR Publications

ABSTRACT

Background:

Diabetic foot ulcers (DFUs) are a devastating complication of diabetes and a leading cause of non-traumatic foot amputations. Traditional methods of monitoring and managing patients with diabetes, such as periodic in-person clinic visits, may not be sufficient for preventing DFUs and amputations. Continuous Remote Temperature Monitoring has the potential to capture the critical period before the foot ulcers develop and to improve outcomes by providing real-time data and early interventions. For the first time, the effectiveness of such a strategy to prevent DFUs and amputations among high-risk patients in a real-world commercial setting is reported.

Objective:

The aim of this study is to evaluate the effectiveness of a real-world continuous remote temperature monitoring program in preventing DFUs and amputations in patients with diabetes.

Methods:

In this retrospective analysis of a real-world continuous remote temperature monitoring program, 109 high risk patients identified by clinical providers from 15 geographically diverse private podiatry offices were analyzed. Patients received continuous remote monitoring socks as part of the program. The enrollment was based on medical necessity as decided by their managing physician. We evaluated data from up to 2 years before enrollment and up to 3 years during the program. Primary outcome was the rate of wound development. Secondary outcomes included amputation rate, severity of the foot ulcers, and the number of visits to an outpatient podiatry clinic after enrolling in the program.

Results:

We observed significantly lower rates of foot ulceration (relative risk reduction (RRR) 0.69; number needed to treat (NNT) 5.0; 95% CI 0.80, 0.53; p<0.0001), less moderate to severe ulcers (RRR 0.87; NNT 15.3; 95% CI 0.94, 0.72; p<0.0001), less amputations (RRR 0.87; NNT 74.8; 95% CI 0.98, 0.047; p<0.0056), and less hospitalizations (RRR 0.65; NNT 9.4; 95% CI 0.82, 0.33; p<0.0016). We found an increase in outpatient podiatry office visits during the program (RRR 1.27; absolute risk reduction (ARR) 1.45; 95% CI 0.162, 0.397; p<0.0001).

Conclusions:

Our findings suggested that a real-world continuous remote temperature monitoring program was an effective strategy to prevent DFU development and non-traumatic foot amputation among high-risk patients. Clinical Trial: WCG-IRB (1284366)