A study entitled “Reproducibility of the New Indicator Test for Sudomotor Function (Neuropad®) in Patients with Type 2 Diabetes Mellitus” was undertaken in University Hospital of Alexandroupolis, Greece to assess the reproducibility of Neuropad.
In a 2005 short-communication study, the reproducibility of Neuropad was assessed in 142 individuals with type 2 diabetes (mean age ~67 years, duration ~14 years). Each participant underwent two consecutive Neuropad evaluations on separate days, and in 60 of them, inter-observer variability was additionally examined.
Key reproducibility findings include:
- Intra‑subject consistency: The time to complete colour change (from blue to pink)-a quantitative measure of sweat response-showed strong correlation between successive tests, with coefficients of r = 0.91 for the right foot and r = 0.89 for the left foot (both p = 0.001).
- Diagnostic agreement: Sudomotor impairment classification was identical in 98% of paired assessments, indicating highly consistent test interpretation.
- Operator consistency: Inter-observer reproducibility was also excellent, regardless of the presence or absence of dysfunction, with intra- and inter-observer coefficients of variation between 4.1% and 5.1%.
These metrics underscore Neuropad’s excellent reliability-both within individuals across time and between different users. Such reproducibility is critical for any clinical tool meant for repeated use-whether in routine diabetes screenings, longitudinal monitoring, or self-assessment contexts.
The study confirms that Neuropad is operationally dependable. Its objective readout-strongly reproducible and minimally operator-dependent-makes it a sound candidate for widespread implementation in diabetes care, enhancing both early detection and ongoing surveillance of autonomic small-fibre dysfunction.