Implementation of a novel mHealth application (INTELLIN®) for the management of people with diabetes and recently healed foot ulceration: a feasibility study (Preprint)
Authors: Haycocks Samantha , Cameron Rory , Edge Mark , Chadwick Paul 
Published: July 2021

BACKGROUND

Diabetic foot ulcers (DFUs) cause significant morbidity and mortality. Faster and more appropriate referral to specialist clinics after symptom onset has been linked to a reduced risk of patients developing severe DFUs. The INTELLIN® diabetes management platform is a novel mHealth application for the management of recently healed DFUs, promoting clinic engagement and expediting self-referral.

OBJECTIVE

Aims were to determine the acceptability, suitability and usability of the INTELLIN® platform, as assessed by the patients and the clinical team; and to assess the proportion of patients who self-refer for DFU recurrence over 12 months.

METHODS

Patients from the Salford Royal NHS Foundation Trust attended follow-up visits at Weeks 1, 4, 16, 28, 40 and 52. Time until reulceration was measured through Week 52, whilst the Site, Ischemia, Neuropathy, Bacterial Infection, and Depth (SINBAD) score was assessed at screening and at any instances of DFU recurrence. The proportion of patients who self-referred for recurrence was also assessed, and patients and clinic staff completed questionnaires to assess platform usability. A Markov cost-utility model was used to predict quality-adjusted life-years (QALYs) and costs to calculate an incremental cost effectiveness ratio (ICER) and indicate the level of benefit INTELLIN® would need to deliver in terms of prevention of DFU recurrence to achieve cost-effectiveness.

RESULTS

One hundred and ninety-seven patients were assessed for eligibility and 15 entered the full analysis set (FAS). Through Week 52, 8/15 FAS patients experienced a recurrence, with a mean (SD) SINBAD score of 2.1 (1.0) and a mean duration of 2.6 days. Mean time from last DFU to recurrence during follow-up was 273.0 days (95% CI 74.0, 484.0). No patients self-referred during the study. Despite the small sample size, initial qualitative data showed high INTELLIN® platform acceptability and usability for patients and clinicians, with high likelihood of recommendation for future use. In this model, the INTELLIN® platform only required a relative reduction in DFU recurrence of 5% compared with standard of care (SoC) to attain an ICER of £20 000 per QALY, suggesting the potential for significant healthcare cost savings upon wider adoption of the INTELLIN® platform. The substantial barriers to enrolment encountered in this study demonstrate the considerable impact of socio-economic factors on mHealth studies, specifically in this study in patients with diabetes.

CONCLUSIONS

The results of this feasibility and accessibility study combined with a health economics and outcomes research (HEOR) evaluation suggest that the INTELLIN® platform is required to provide only a small reduction in DFU recurrence compared to SoC to be a cost-effective strategy for the prevention of recurrent DFUs. This is a promising result and supports the future development of a comparative study to evaluate effectiveness of the platform in patients with complications due to diabetes.