Implementation of a novel mHealth application for the management of people with diabetes and recently healed foot ulceration: A feasibility study

BACKGROUND: Diabetic foot ulcers (DFUs) cause significant morbidity and mortality. Faster referral to specialist clinics is associated with a reduced risk of severe DFUs. The INTELLIN(®) diabetes management platform is a novel mHealth application for the management of recently healed DFUs and other complications, promoting engagement and expediting self-referral. METHODS: To determine the acceptability, suitability, and usability of the INTELLIN(®) platform, time until reulceration, site, ischemia, neuropathy, bacterial infection, and depth (SINBAD) score and incidence of self-referral for recurrence were assessed in patients from the Salford Royal NHS Foundation Trust. Patients and clinic staff also assessed platform usability. A Markov cost-utility model was used for the health economics and outcomes research analysis. RESULTS: 197 patients were assessed for eligibility and 15 entered the full analysis set (FAS). Through Week 52, 8/15 patients experienced recurrence, with a mean SINBAD score of 2.1 and mean duration of 2.6 days. Mean time to recurrence was 273.0 days (95% confidence interval 74.0, 484.0). No patients self-referred. Initial qualitative data showed high platform usability. The INTELLIN(®) platform only required a relative reduction in recurrence of 5% versus standard of care (SoC) for an incremental cost effectiveness ratio of £20,000 per quality-adjusted life-year, suggesting potential for significant cost savings upon wider adoption. The barriers to enrollment encountered demonstrate the impact of socioeconomics on mHealth. CONCLUSIONS: These results suggest that the INTELLIN(®) platform is required to provide only a small reduction in recurrence compared to SoC to be a cost-effective strategy for prevention of recurrent DFUs.