Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial

<ns4:p><ns4:bold>Background</ns4:bold>: Three previous clinical trials have found that thermometry use reduced diabetic foot ulcers (DFUs) incidence four- to ten-fold among individuals with diabetes at high-risk of developing a DFU. However, these benefits depend on patient adherence to self-assessment. Therefore, novel approaches to improve self-management thermometry adherence are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders intervention arm vs. thermometry-only control arm.</ns4:p><ns4:p> <ns4:bold>Methods</ns4:bold>: We conducted a randomized trial, enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted.</ns4:p><ns4:p> <ns4:bold>Results</ns4:bold>: A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the Hazard Ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook, with no difference between the intervention and control arms.</ns4:p><ns4:p> <ns4:bold>Conclusions</ns4:bold>: This trial contributes to the evidence about the value of mHealth in preventing diabetes foot ulcers.</ns4:p><ns4:p> <ns4:bold>Trial registration</ns4:bold>: ClinicalTrials.gov <ns4:ext-link xmlns:ns3="http://www.w3.org/1999/xlink" ext-link-type="uri" ns3:href="https://clinicaltrials.gov/ct2/show/NCT02373592">NCT02373592</ns4:ext-link> (27/02/2015)</ns4:p>