Clinical Use, Interpretation, and Limitations of Sudoscan in Diabetes Care

Abstract

Background

Diabetic peripheral neuropathy (DPN) and diabetic autonomic neuropathy (DAN) are prevalent yet underdiagnosed complications. While not a replacement for traditional diagnostics, Sudoscan is a noninvasive, rapid diagnostic device that evaluates sudomotor function through electrochemical skin conductance (ESC), offering a promising tool for screening neuropathic complications in routine clinical settings.

Objectives

This practice point article is a narrative review of the indications, clinical utility, interpretation, and limitations of Sudoscan within diabetes clinics.

Key Practical Points

Evidence suggests that Sudoscan demonstrates high sensitivity (up to 87.5%) and moderate specificity for detecting DPN and DAN. It provides objective, quick assessments, and its operation does not require specialized training, enhancing feasibility in primary care and specialty clinics. The ESC and cardiovascular autonomic neuropathy risk scores derived from Sudoscan correlate with established tests, such as nerve conduction studies and cardiovascular reflex tests. Furthermore, Sudoscan supports early detection, risk stratification, and monitoring of disease progression. Despite its advantages, Sudoscan's diagnostic accuracy can be influenced by factors such as age and ethnicity, and ESC thresholds remain an area requiring standardization. It is most effective when used as part of a broader diagnostic strategy.

Conclusion

This article provides clinicians with practical guidance on integrating Sudoscan into diabetes care, thereby enhancing the early identification and management of neuropathic complications.

 

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Keywords

diabetic neuropathy - sudoscan - autonomic dysfunction - diabetes screening - electrochemical skin conductance - small fiber neuropathy

Introduction

Diabetic peripheral neuropathy (DPN) is length-dependent peripheral nerve damage arising as a complication of type 1 diabetes (T1D) or type 2 diabetes (T2D) in up to 50% of patients. DPN poses a substantial burden on patients, who can experience impaired gait and loss of balance, predisposing them to falls and fractures, and neuropathic pain, which is frequently difficult to treat and reduces quality of life. Advanced DPN can lead to diabetic foot ulcers and nonhealing wounds that often necessitate lower-limb amputation.[1]

Periodic screening for microvascular complications is key in diabetes care. These include screening for neuropathy, nephropathy, and retinopathy in T2D from the time of recognition, and in T1D, a few years after diagnosis.[2] Screening for neuropathy remains less advanced compared with nephropathy and retinopathy due to a lack of standard tools and variability in symptoms.[3]

Sudoscan is a noninvasive device used in diabetes clinics to assess sudomotor function. It measures the electrochemical skin conductance (ESC) of the hands and feet through reverse iontophoresis and chronoamperometry. The test does not require any special preparation. Patients place their hands and feet on electrodes, and the device measures the ESC, which reflects the function of small nerve fibers responsible for sweat gland activity.[4] [5] [6] [7] This technology is particularly useful for detecting DPN and cardiovascular autonomic neuropathy (CAN).[8] [9]

Sudoscan is now more frequently adopted in internal medicine and diabetes clinics. Most health insurance funders in many parts of the world generously reimburse the cost of autonomic function testing procedures (CPT Code 95923). Understanding the principles and practical considerations is essential for the effective clinical integration of this tool.

 

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Materials and Methods

This practice point aims to provide a concise, descriptive, practical account to optimize its utility in the clinical setting. A narrative review approach was employed using the PubMed database, focusing on literature published from 2011 to 2025. No specific exclusions were applied. A total of 181 articles were retrieved in response to the search term (Sudoscan). The search was expanded to make comparisons with other methods and other contextual arguments. Articles were selected based on their relevance to a predefined set of clinical questions. The questions covered indications, contraindications, practical utility, clinical effectiveness, cost-effectiveness, interpretations, the impact of age and ethnicity, the impact on treatment decisions, and limitations. The practical aims of the article may have led to an overreliance on review articles and guidelines and avoidance of detailed data presentations. To illustrate the interpretation of Sudoscan findings in clinical practice, a series of enhanced, anonymized, real clinical cases with normal, moderate, and advanced sudomotor dysfunction was used.

 

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Emerging Themes

Indications and Contraindications

Sudoscan is indicated for assessing sudomotor function, which is particularly useful in the early detection of DPN and diabetic autonomic neuropathy (DAN).[6] [7] It is also used to screen for CAN in patients with diabetes.[8] [9]

Sudoscan use is inappropriate in the presence of skin lesions, wounds, or dermatological conditions (such as ulcers, severe eczema, or infections) on the palms or soles, as these may interfere with electrode contact and the accuracy of ESC measurements. Additionally, patients with implanted electronic medical devices should avoid Sudoscan, as the device uses low-voltage electrical currents for reverse iontophoresis, and safety in this population has not been established. The test is also inappropriate in individuals unable to maintain adequate contact with the electrodes due to severe motor impairment, cognitive dysfunction, or major foot deformities. The diagnostic utility of Sudoscan in acute neuropathic conditions or the presence of significant peripheral edema is uncertain. These limitations are consistent with the technical and clinical descriptions in the medical literature, which emphasize the need for intact, clean, and dry skin for reliable results.[4] [5] [10]

 

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Practical Utility

Sudoscan can quickly and objectively screen for DPN.[6] [7] It can also assess CAN, with the CAN risk score correlating with traditional cardiovascular reflex tests.[8] [9] [11] While Sudoscan is a valuable screening tool, it has limitations. The specificity of Sudoscan for diagnosing CAN is moderate, and it should be used in conjunction with other diagnostic modalities for a comprehensive assessment.[5] [9] [11]

 

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Clinical Effectiveness

Sudoscan measures the ESC of the hands and feet, which reflects the function of small nerve fibers responsible for sweat gland activity. Studies have shown that Sudoscan is effective in detecting DPN and DAN. For instance, foot ESC values are significantly lower in patients with DPN than in those without DPN and healthy controls. Similarly, patients with DAN exhibit lower ESC values than those without DAN.[7] [8] [9] [10] [11]

The sensitivity and specificity of Sudoscan for detecting DPN and small fiber neuropathy (SFN) have been evaluated in multiple clinical contexts ([Table 1]). In summary, sensitivity ranges widely from 53 to 92%, which is high, especially for SFN and autonomic neuropathy. Specificity varies equally widely (49–99%), often depending on ESC thresholds and population. Area under the curve values suggest good overall diagnostic accuracy (≥0.75) in most contexts. Finally, performance is strongest in moderate-to-severe SFN and CAN.[5] [6] [7] [8] [10] [11]

Table 1 Sudoscan diagnostic performance across studies

Population/context	Diagnostic target	Sensitivity	Specificity	Study/source
People with diabetes	Diabetic peripheral neuropathy	87.5%	76.2%	Selvarajah et al (2015)
Mixed diabetic and nondiabetic neuropathies	Moderate SFN (ESC ≤70 μS)	91.0%	97.0%	Riveline et al (2023)
	Severe SFN (ESC ≤50 μS)	91.0%	99.0%
People with type 2 diabetes	Foot ESC for DPN	70.0%	85.0%	Krieger et al (2018)
	Hand ESC for DPN	53.0%	50.0%
Chinese population	Cardiovascular autonomic neuropathy	85.6%	76.1%	Jin et al (2018)
Diabetes cohort (United States)	Diabetic neuropathy	78.0%	92.0%	Casellini et al (2013)
People with diabetes	CAN risk score-based	92.0%	49.0%	Yajnik et al (2013)

Abbreviations: CAN, cardiovascular autonomic neuropathy; DPN, diabetic peripheral neuropathy; ESC, electrochemical skin conductance; SFN, small fiber neuropathy.

Sudoscan is a noninvasive test that can be performed quickly, making it highly efficient for routine clinical use. Traditional methods, such as nerve conduction studies (NCS) and skin biopsies, are more time-consuming and invasive, increasing costs related to patient discomfort and procedural complications.[5] [6] [7] The operational costs of Sudoscan are relatively low compared with traditional methods. NCS and skin biopsies require specialized equipment and trained personnel. Sudoscan, on the other hand, can be operated by nonspecialized staff, reducing labor costs.[4] [5] [6] Sudoscan's ease of use and quick turnaround time make it feasible for integration into routine diabetes care, ensuring adherence to guidelines such as those from the American Diabetes Association.[2] This service can improve patient compliance and reduce the need for multiple clinic visits.[3] [4] [5] [6]

 

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Interpretation

Lower ESC values in the hands and feet indicate impaired sudomotor function, which is associated with DPN and CAN. Specific cutoff values have been established to aid diagnosis.[12] The reports use three color codes for normal (green), moderate impairment (amber), and severe impairment (red) sudomotor functions. The provided illustrations are real anonymized clinical cases assessed by the same instrument. [Figs. 1] [2] to [3] show the illustrations from three technical reports. [Fig. 1] depicts an example of the illustration from a report of a person with normal sudomotor function. [Fig. 2] shows a report of a patient with moderate sudomotor dysfunction. [Fig. 3] demonstrates a report of a patient with markedly impaired sudomotor function. For educational purposes, patients are provided with a simplified illustrated report. [Fig. 4] illustrates the visual components of three reports, including one for patients with normal findings and another for those with significantly abnormal results. The software provides reports with spaces for comments and plans of further action, a signature, and a doctor's seal. Example actions may include intensifying glycemic control, investigating other causes of neuropathy, or referral for specialized neurological evaluations. The documentation can be linked directly to the electronic medical records or manually scanned and uploaded as ancillary tests.

Fig. 1 Professional report of the mean ESC scores, regional conductance, and symmetry of a patient with normal sudomotor function in the feet (upper) and the hands (lower). The reports use three color codes for normal (green), moderate impairment (amber), and severe impairment (red) sudomotor functions. ESC, electrochemical skin conductance.

Fig. 2 Professional report of the mean ESC scores, regional conductance, and symmetry of a patient with moderate sudomotor dysfunction. The reports use three color codes for normal (green), moderate impairment (amber), and severe impairment (red) sudomotor functions. ESC, electrochemical skin conductance.

Fig. 3 Professional report of the mean ESC scores, regional conductance, and symmetry of a patient with advanced sudomotor dysfunction. The reports use three color codes for normal (green), moderate impairment (amber), and severe impairment (red) sudomotor functions. ESC, electrochemical skin conductance.

Fig. 4 Illustrations from reports given to patients: The upper panel shows a report of a patient with normal sudomotor function, the middle panel shows a moderately impaired sudomotor function, and the lower panel shows a report of a patient with a severely impaired sudomotor function. The reports use three color codes for normal (green), moderate impairment (amber), and severe impairment (red) sudomotor functions.

 

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Impact of Age and Ethnicity

Additionally, factors such as age and ethnicity can influence ESC values, which should be taken into account when interpreting the results.[11] [12] [13] [14] Age has a statistically significant but weak negative correlation with Sudoscan ESC; the values decrease slightly with increasing age, but the effect size is small and unlikely to be clinically significant in most cases. Ethnicity has a notable impact: African American, Indian, and Chinese individuals have lower mean ESC values compared with white populations, indicating that ethnicity-specific reference ranges may be necessary for accurate interpretation. Sex does not significantly affect ESC values; studies have shown no meaningful difference in ESC between men and women at either the hands or feet.[13] [14] [15] Hydration status was not directly addressed in the literature. However, as Sudoscan measures sweat gland function, severe dehydration could theoretically reduce sweat production and thus ESC, but this has not been established.[15]

 

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Comparison of Diagnostic Tools for Peripheral Neuropathy

Several methods are available for diagnosing DPN. [Table 2] highlights the differences between the characteristics of Sudoscan, quantitative sensory testing, NCS, and skin biopsies.[5] [12] [13] [16] [17] [18] [19] [20] [21] [22] [23] [24] [25] [26] [27] [28] [29] [30] [31] [32] [33] [34] [35] Sudoscan, NCS, skin biopsy, and corneal confocal microscopy (CCM) are complementary tools for evaluating peripheral neuropathy, each with distinct strengths and limitations. A detailed discussion of the issue is out of the scope of this practice point. However, NCS is best suited for large fiber neuropathy. In contrast, skin biopsy is the gold standard for SFN. Sudoscan is a rapid screening tool for autonomic small fiber dysfunction, and CCM is a noninvasive method for assessing small fibers. Selection depends on the clinical context and the type of fiber of interest and the local access.

Table 2 Comparison of the various attributes of Sudoscan, QST, CCM, NCS, and skin biopsy as diagnostic tools for peripheral neuropathy

Feature	Sudoscan[5] [7] [10]	QST[24] [25]	CCM[27] [28] [29] [30] [31] [32] [33]	NCS[21] [22]	Skin biopsy[23] [34] [35]
Primary assessment	Sudomotor/autonomic small fiber function	Sensory thresholds (thermal, vibratory)	Corneal nerve fiber density and morphology	Large fiber function (motor and sensory nerves)	Small fiber nerve density in skin
Invasiveness	Noninvasive	Noninvasive	Noninvasive	Noninvasive	Minimally invasive
Subjectivity	Objective	Subjective (patient-dependent)	Objective	Objective	Objective
Sensitivity	70–87% (for DPN)	69–78% (small fiber nerve)	14–88%	36–85% (large fiber nerve)	Up to 91%
Specificity	76–92%	70–84%	75–96%	High for large fiber neuropathy	Up to 99%
Clinical utility	Screening and monitoring (especially DPN)	Detects both large and small fiber abnormalities	Research and longitudinal tracking	Gold standard for large fiber involvement	Gold standard for small fiber neuropathy
Cost	Moderate	Low	High	Moderate	Moderate
Accessibility	High (outpatient clinics)	Moderate–high (neurology clinics)	Low (research centers)	High (widely available)	Moderate (requires laboratory access)
Technical requirements	Minimal training, no preparation	Trained operator, patient cooperation	Specialized equipment and training	Electrophysiology laboratory, trained personnel	Biopsy skills + histology laboratory
Time to results	3–5 min	20–60 min	15–30 min (imaging + analysis)	30–90 min (including interpretation)	Days (for laboratory processing)
Strengths	Rapid, point-of-care, correlates with clinical signs	Functional assessment of pain and sensory abnormalities	Visualizes nerve regeneration and degeneration	Objective, well-validated, reliable for large fiber disease	Quantitative, validated, high sensitivity/specificity
Limitations	Less established for nondiabetic neuropathy	Patient-dependent, not a standalone diagnostic	High cost, access	Cannot detect small fiber neuropathy	Invasive, sampling error possible

Abbreviations: CCM, corneal confocal microscopy; DPN, diabetic peripheral neuropathy; NCS, nerve conduction studies; QST, quantitative sensory testing.

 

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Impact on Treatment Decisions

Management decisions may be supported by providing a quick, noninvasive, and objective assessment of sudomotor function, which is crucial for detecting DPN and CAN. Given its high sensitivity and moderate specificity, Sudoscan can be particularly useful in the following ways. Early detection of neuropathic complications allows for timely intervention. Early identification of DPN and CAN should prompt clinicians to intensify glycemic control and implement lifestyle modifications to prevent progression.[4] [6] [13] Sudoscan may monitor the progression of neuropathy over time. Regular assessments can help evaluate the effectiveness of therapeutic interventions and adjust treatment plans accordingly.[3] [10] Sudoscan facilitates adherence to guidelines that recommend annual neuropathy assessments for patients with diabetes.[4] [5] Incorporation of the reports in patients' electronic health records should help longitudinal monitoring. However, no evidence supports a role for monitoring change in therapeutic trials.[35] The CAN risk score provided by Sudoscan helps stratify patients based on their risk of autonomic dysfunction. This information can help clinicians in prioritizing patients for more detailed autonomic testing and tailored management strategies.[4] [11]

 

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Limitations

For a practice point article, a narrative review was considered the most suitable approach. However, the nature of the narrative review could limit its scientific rigor. The research is limited by its relatively small literature volume (n = 181), restricted study populations, and limited ethnic diversity, among other potential confounders. Additionally, this article focused on practical applications to help better utilize this technology, rather than providing exhaustive coverage of the subject. However, available data on sensitivity and specificity in different contexts are included in [Table 1]. Also, qualitative comparisons were made with other diagnostic tools in [Table 2] for completeness.

 

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Conclusion

Sudoscan represents a practical and noninvasive tool for the early detection and monitoring of DPN and DAN. Its ease of use makes it well-suited for integration into routine diabetes care, especially in primary and outpatient clinical settings. By enabling the rapid and objective assessment of sudomotor function, Sudoscan supports timely interventions that may help mitigate disease progression and improve long-term outcomes for individuals with diabetes. However, while Sudoscan offers significant advantages in terms of efficiency and accessibility, it should not be used in isolation. Its moderate specificity and susceptibility to confounding variables—such as age and ethnicity—necessitate its use in conjunction with other established diagnostic modalities, including NCS and cardiovascular reflex tests, particularly when definitive diagnosis or treatment decisions are being made.

Future research should standardize ESC thresholds across diverse populations and clinical settings, and further explore the role of Sudoscan in longitudinal disease monitoring. In addition, studies evaluating the impact of Sudoscan-guided interventions on patient outcomes and health care resource utilization would strengthen its position in clinical algorithms. Studies should assess how integrating Sudoscan into diabetes clinics affects long-term morbidity, adherence, and cost savings. Overall, Sudoscan enhances the clinician's ability to detect neuropathic complications early and tailor care more precisely, advancing personalized diabetes management in an increasingly complex health care landscape.

 

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Conflict of Interest

None declared.

Author's Contribution

The author who proposed the study, performed the literature searches, and drafted the manuscript.

Compliance with Ethical Principles

No ethical approval is required for a review-type study.

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Publication History

Article published online:
08 September 2025