Cost-effectiveness and cost-utility of at-home foot temperature monitoring to help prevent foot ulcer recurrence in people with diabetes: a health-economic multicentre randomized controlled trial (DIATEMP)

Background: Foot ulcers in people with diabetes are common, costly, and they frequently recur. To better inform stakeholders on ulcer recurrence prevention, we economically evaluated the effectiveness of at-home foot skin temperature monitoring. <br> Methods: In this multicentre RCT, we randomly assigned people with diabetes, neuropathy, foot ulcer history or Charcot’s neuro-arthropathy to usual care plus daily foot skin temperature measurements at 6-8 sites (enhanced therapy) or usual care. Foot care costs were obtained via questionnaires and medical records. Health-related quality of life was assessed with the EQ-5D-3L. Clinical outcome was foot ulcer recurrence in 18 months. Incremental cost-effectiveness and cost-utility ratios were calculated and visualized through cost-effectiveness planes and corresponding cost-effectiveness acceptability curves for willingness-to-pay/accept levels up to €100,000 after non-parametric bootstrapping. <br> Findings: Foot care costs per participant during 18 months were non-significantly lower for enhanced therapy (n=151; mean:€6,067 (SD:€13,778)) compared to usual care (n=153; mean:€7,376 (SD:€15,790); P=0·45). Enhanced therapy saved €11,580 per ulcer prevented and had 79% probability of being cost-effective at a willingness-to-pay of €0 per ulcer-free participant. Quality-adjusted life years were non-significantly lower in enhanced therapy (mean:1·085 (SD:0·33)) compared to usual care (mean:1·119 (SD:0·31); P=0·35). Enhanced therapy saved €37,389 per QALY lost and had 45% probability of being cost-effective at a willingness-to-accept of €50,000 per QALY lost. <br> Interpretation: In this first-ever health-economic RCT in diabetic foot ulcer prevention, at-home foot temperature monitoring was cost-effective over usual care in ulcers prevented, but at best equally cost-effective when focusing on QALYs. <br> Dataset: The dataset attached here contains the primary health and economic outcomes for participants in the DIATEMP RCT. <br> <br>