Detection of sudomotor alterations evaluated by Sudoscan in patients with recently diagnosed type 2 diabetes

BMJ Open Diabetes Res Care. 2022 Dec;10(6):e003005. doi: 10.1136/bmjdrc-2022-003005.

Abstract

Introduction: Diabetic peripheral neuropathy (DPN) causes morbidity and affects the quality of life. Before diabetes diagnosis, neuropathic damage may be present. Sudoscan provides accurate measurement of the sudomotor function. This study aimed to assess the abnormalities detected by Sudoscan, offered estimates of DPN prevalence, and investigated the relationship between metabolic and clinical parameters. Additionally, we evaluated the diagnostic accuracy of the Sudoscan compared with monofilament and tuning fork tests for detecting DPN.

Research design and methods: Cross-sectional descriptive study including patients with type 2 diabetes for <5 years since diagnosis. We investigated the presence of DPN using a 128 Hz tuning fork test, the 10 g monofilament, and the sudomotor dysfunction in feet using Sudoscan. We compared patients with and without alterations in the Sudoscan. A logistic regression model analyzed variables independently associated with sudomotor dysfunction.

Results: From 2013 to 2020, 2243 patients were included, 55.1% women, age 51.8 years, and 17.1% with normal weight. Monofilament tests and/or tuning fork examination were abnormal in 29% (95% CI 0.23% to 0.27%) and 619 patients (27.6%, 0.25% to 0.29%) had sudomotor alterations. In logistic regression analysis, age (β=1.01, 0.005-1.02), diastolic blood pressure (β=0.98, 0.96-0.99), heart rate (β=1.01, 1.00-1.02), glucose (β=1.00, 1.00-1.03), albuminuria (β=1.001, 1.000-1.001), beta-blockers=1.98, 1.21-3.24) and fibrate use=0.61, 0.43-0.87) were associated with sudomotor dysfunction. The AUC (area under the curve) for Sudoscan was 0.495 (0.469-0.522), with sensitivity and specificity of 24% and 71%, respectively.

Conclusion: The Sudoscan identified an important proportion of patients with dysfunction, allowing prompt intervention to decrease the risk for complications.

Trial registration number: NCT02836808.

Keywords: Diabetes Mellitus, Type 2; Diabetic Neuropathies; Foot; Normal.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cross-Sectional Studies
  • Diabetes Mellitus, Type 2* / complications
  • Diabetic Neuropathies* / diagnosis
  • Diabetic Neuropathies* / epidemiology
  • Female
  • Humans
  • Male
  • Middle Aged
  • Quality of Life

Associated data

  • ClinicalTrials.gov/NCT02836808