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

Abstract

Background: Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control). Methods: 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. 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 previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. 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). Conclusions: In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met. Trial registration: ClinicalTrials.gov NCT02373592 (27/02/2015)

Efeito da termometria na prevenção de úlceras de pé diabético: revisão sistemática com metanálise

“…The reference is a corresponding area on the contralateral foot. It is noteworthy that the temperatures of these areas do not differ by more than 1ºC 5 - 6 and a number of studies suggest that differences ≥ 2.2ºC in temperature can be considered a risk for ulceration 11 , 16 - 18 .…”

Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP)

“…33 Data from a recent trial confirm that text and voice reminders in using thermometry do not affect adherence and outcome. 37 This may be inherent to this treatment approach and addresses an important barrier to implementation.…”

Going digital: opportunities and barriers in the use of technology for health research

“…41 Based on this finding, a randomized controlled trial in Peru implemented the use of thermometry in 172 participants from two public national hospitals and one study arm was supplemented with a mHealth intervention involving SMS and voice messages. 42 It was found that 90% of the participants who returned their logbooks reported adherence to temperature measurement above 80%. However, the mHealth arm was not effective to reduce the incidence of diabetic foot ulcers.…”

“…However, the mHealth arm was not effective to reduce the incidence of diabetic foot ulcers. 42 This study faced some challenges, including the high proportion of people with diabetes that did not know how to open an SMS message. Trying to overcome this barrier, voice messages were also considered in the study design.…”