A prospective study on the use of the indicator test Neuropad® for the early diagnosis of peripheral neuropathy in type 2 diabetes

Exp Clin Endocrinol Diabetes. 2011 Feb;119(2):122-5. doi: 10.1055/s-0030-1261934. Epub 2010 Aug 5.


Aim: The aim of this prospective study was to evaluate the contribution of the indicator test for sudomotor function Neuropad® to the early diagnosis of peripheral neuropathy in patients with type 2 diabetes mellitus. Included were 109 type 2 diabetic patients (55 men, mean age 56.15 ± 6.14 years), whose initial clinical examination (Neuropathy Disability Score, NDS) was negative for neuropathy. Patients were first examined between January and June 2004 and re-examined 5 years later by the NDS and Neuropad ®. Initially, 70 patients (64.22%) had normal and 39 (35.78%) patients had abnormal Neuropad® (groups A and B, respectively). NDS was significantly higher in group B on both examinations (p < 0.001). On the second examination, 2 patients (2.86%) in group A and 10 patients (25.64%) in group B had developed neuropathy (p = 0.001). Neuropad® had 83.33% sensitivity and 68.04% specificity for neuropathy. There was a modest but significant agreement (kappa = 0.259, p < 0.001) between Neuropad® and NDS for neuropathy.

Conclusions: Among type 2 diabetic patients with normal NDS, development of neuropathy is significantly more frequent in those with abnormal Neuropad®. These results suggest a potential utility of Neuropad® for the earlier diagnosis of neuropathy in type 2 diabetes.

Publication types

  • Evaluation Study

MeSH terms

  • Diabetes Mellitus, Type 2 / complications*
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetic Neuropathies / diagnosis*
  • Early Diagnosis
  • False Positive Reactions
  • Female
  • Humans
  • Indicators and Reagents / pharmacology
  • Male
  • Middle Aged
  • Prospective Studies
  • Reagent Kits, Diagnostic*
  • Sensitivity and Specificity


  • Indicators and Reagents
  • Reagent Kits, Diagnostic