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


 BACKGROUND
 Thermometry monitoring has proven to reduce the occurrence of diabetic foot ulcers (DFU). mHealth may contribute to enhance adherence to this effective intervention.
 
 
 OBJECTIVE
 Our objective was to compare incidence of DFU in the thermometry plus mHealth reminders intervention arm vs. thermometry-only control arm.
 
 
 METHODS
 We conducted a randomized trial enrolling adults with type 2 diabetes mellitus with foot-at-risk (risk groups 2 or 3) without foot ulcers and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or to intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted.
 
 
 RESULTS
 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 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 that returned the logbook, without difference between intervention and control arm.
 
 
 CONCLUSIONS
 This trial contributes to the evidence about the value of mHealth to prevent diabetes foot ulcers.
 
 
 CLINICALTRIAL
 Clinical trials, NCT02373592. Registered 27 February 2015, https://clinicaltrials.gov/ct2/show/NCT02373592
