Cost‐effectiveness of temperature monitoring to help prevent foot ulcer recurrence in people with diabetes: A multicenter randomized controlled trial

Abstract Aims Diabetes‐related foot ulcers are common, costly, and frequently recur. Multiple interventions help prevent these ulcers. However, none of these have been prospectively investigated for cost‐effectiveness. Our aim was to evaluate the cost‐effectiveness of at‐home skin temperature monitoring to help prevent diabetes‐related foot ulcer recurrence. Materials and Methods Multicenter randomized controlled trial. We randomized 304 persons at high diabetes‐related foot ulcer risk to either usual foot care plus daily at‐home foot skin temperature monitoring (intervention) or usual care alone (control). Primary outcome was cost‐effectiveness based on foot care costs and quality‐adjusted life years (QALY) during 18 months follow‐up. Foot care costs included costs for ulcer prevention (e.g., footwear, podiatry) and for ulcer treatment when required (e.g., consultation, hospitalisation, amputation). Incremental cost‐effectiveness ratios were calculated for intervention versus usual care using probabilistic sensitivity analysis for willingness‐to‐pay/accept levels up to €100,000. Results The intervention had a 45% probability of being cost‐effective at a willingness‐to‐accept of €50,000 per QALY lost. This resulted from (non‐significantly) lower foot care costs in the intervention group (€6067 vs. €7376; p = 0.45) because of (significantly) fewer participants with ulcer recurrence(s) in 18 months (36% vs. 47%; p = 0.045); however, QALYs were (non‐significantly) lower in the intervention group (1.09 vs. 1.12; p = 0.35), especially in those without foot ulcer recurrence (1.09 vs. 1.17; p = 0.10). Conclusions At‐home skin temperature monitoring for diabetes‐related foot ulcer prevention compared with usual care is at best equally cost‐effective. The intervention resulted in cost‐savings due to preventing foot ulcer recurrence and related costs, but this came at the expense of QALY loss, potentially from self‐monitoring burdens.