Evaluation of a smartphone-based point-of-care neuropathy testing device for remote monitoring and early detection in diabetic patients: A clinical study comparing accuracy and feasibility with traditional neurothesiometer for improved management of diabetic peripheral neuropathy and foot care in routine clinical practice.

Abstract

Aims/Objectives: Peripheral neuropathy is a common complication in diabetes, leading to loss of sensation, ulceration, and amputation risks. Current assessments depend on infrequent professional reviews, delaying diagnosis and treatment. This study evaluated a smartphone-based point-of-care neuropathy testing device that would allow patients to monitor their condition remotely. The study aimed to validate its accuracy compared to the Neurothesiometer. Methods: Participants with diabetes were recruited from clinics and community invites. Each participant completed the Diabetic Foot Disease and Foot Care questionnaire (DFDFC-Q) and underwent neuropathy assessment with a Neurothesiometer and the new device. The study was conducted in two stages: accuracy comparison using Bland-Altman analysis and test-retest reliability assessments. Adverse Device Events (ADEs) and Serious Adverse Effects (SADES) were monitored. Usability data was collected from patients, buddies, and healthcare providers (HCPs) using the NASA Task scale. The study was ethically approved and funded by NIHR grant 201316. Results: A total of 314 participants with diabetes, 8 buddies, and 6 HCPs completed the tests. The Bland-Altman plot indicated equivalence between the two devices. No ADEs or SADES were reported. Conclusions: Final results, including accuracy comparisons, test-retest data, and usability outcomes, will be available. This study demonstrates the feasibility of using a smartphone-based device for neuropathy assessment and suggests potential improvements for diabetic foot care and patient self-management.