Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes: Sudoscan

Diabetic Neuropathy Rapid Screening Test in Turkish Patients With Type 2 Diabetes Sudoscan

Neuropathy is a frequently observed complication occurring in 60-70% of diabetic patients throughout their lives. In addition, neuropathy is a severe disease that progresses insidiously; its diagnosis can be delayed due to the absence of clinical findings, affects the quality of life, and increases mortality and morbidity. Up to 50% of patients with diabetic peripheral neuropathy (DPN) may be asymptomatic. Typically, DPN progresses in the form of chronic, symmetrical, and progressive sensorimotor polyneuropathy. The five-year mortality rate of individuals with diabetes with autonomic neuropathy is three times higher than those without. The diagnosis of clinical neuropathy is usually made by the symptoms, the vibration sensation with the diapason, and the tactile sensation tests. Although diapason and monofilament tests are easy, they are qualitative tests that the patient must be careful and coordinate with. Biothesiometry or Semmes-Weinstein monofilament tests cannot examine autonomous involvement. Cardiovascular autonomic neuropathy tests based on heart rate variability (HRV), on the other hand, can be affected by factors such as age, body position, cigarette-coffee consumption, blood pressure, exercise, heart rate, and respiratory rate. An easy and fast diagnostic method may be more helpful in diagnosing peripheral and autonomic neuropathy.

Distal small-fiber polyneuropathy can be detected by measuring sweat function using Sudoscan, a rapid, non-invasive, and quantitative method. This measurement method is based on the electrochemical reaction between sweat chlorides and stainless steel electrodes that come into contact with the palms of the hands and soles of the feet. Results are provided as a Diabetic Autonomic Neuropathy (DAN) score based on conductances (micro siemens, μS) and conductivity values for the hands and feet (right and left sides). SUDOSCAN can detect distal small-fiber polyneuropathy with >75% sensitivity. SUDOSCAN can be considered a robust method for detecting sudomotor dysfunction and is used for clinical and research purposes.

In the American Diabetes Association (ADA) consensus statement, sudomotor functions are mentioned in the early diagnosis of autonomic neuropathy in people with diabetes.

This study aimed to evaluate the effectiveness of this method in clinical applications by comparing sudomotor test results with other conventional measurement methods in the evaluation of diabetic peripheral and cardiac neuropathy.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathies; Diabetic Neuropathy Peripheral; Type2Diabetes; Cardiac Autonomic Neuropathy; Neuropathy Autonomic

• Study Type: Observational
• Enrollment (Actual): 437

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study was selected among adult type 2 diabetes patients under control at Istanbul University Istanbul Medical Faculty Diabetes Polyclinic between July 2014 and July 2015. The 437 patients included studying were the ages of 18 and older.

Description

Inclusion Criteria:

• The ability to give informed consent
• Male or female persons >18 years of age with a diagnosis of type 2 DM (WHO criteria)

Exclusion Criteria:

• <18 years of age
• Participants with type 1 diabetes
• Ongoing cancer treatment or other concurrent illness that will make the patient unable to attend the study at the discretion of the investigator
• Pregnant or breastfeeding participants
• Participants with atrial fibrillation, atrial flutter, or pacemakers will not be subjected to cardiac autonomic neuropathy measurements.
• Participants with toe or foot amputations or foot ulcer
• vitamin B12 deficiency and other causes of peripheral neuropathy.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peripheral Neuropathy assesed by sudoscan	Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in feet	15.07.2014 to15.07.2015
Peripheral Neuropathy assesed by sudoscan	Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance (µS) in hands	15.07.2014 to15.07.2015
Peripheral Neuropathy assesed by Monofilament	Neuropathy assesed by Monofilament Light touch with 10 g monofilament	15.07.2014 to15.07.2015
Peripheral Neuropathy assesed by Douleur Neuropathique 4 Questions (DN4)		15.07.2014 to15.07.2015
Peripheral Neuropathy assesed by diapason	Neuropathy assessed by diapason Light touch with 128 Hz diapason	15.07.2014 to15.07.2015
Cardiac Autonomic Neuropathy assesed by electrocardiogram (ECG)	The expiration/inspiration (E/I) ratio was calculated by dividing the mean of the longest RR interval during expiration by the mean of the shortest RR interval during inspiration while the patient was lying quietly and breathing deeply with an electrocardiogram recording the heart rate change. This ratio is considered ≥ 1.21 normal, between 1.11-1.20 borderline, and ≤ 1.1 abnormal.	15.07.2014 to15.07.2015
Peripheral Neuropathy assesed by NC-Stat (Neurometrix)	In the evaluation of Neurometric Measurement; normal limits are >4 microvolts and >40 second meters	15.07.2014 to15.07.2015
Cardiac Autonomic Neuropathy assesed by Othostatic BP change	The blood pressure is measured using a standard sphygmomanometer while the subject is lying down again after standing up. The difference in systolic blood pressure is taken to measure postural blood pressure change. The measured blood pressure difference is considered normal if ≤10 mmHg, borderline between 11-29 mmHg, and abnormal if ≥30 mmHg.	15.07.2014 to15.07.2015

Collaborators and Investigators

• Sponsor: Istanbul University

Publications and helpful links

General Publications

• Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303. Erratum In: Diabetes Care. 2010 Dec;33(12):2725.
• Gin H, Baudoin R, Raffaitin CH, Rigalleau V, Gonzalez C. Non-invasive and quantitative assessment of sudomotor function for peripheral diabetic neuropathy evaluation. Diabetes Metab. 2011 Dec;37(6):527-32. doi: 10.1016/j.diabet.2011.05.003. Epub 2011 Jun 28.
• Mayaudon H, Miloche PO, Bauduceau B. A new simple method for assessing sudomotor function: relevance in type 2 diabetes. Diabetes Metab. 2010 Dec;36(6 Pt 1):450-4. doi: 10.1016/j.diabet.2010.05.004. Epub 2010 Aug 23.
• Ewing DJ, Martyn CN, Young RJ, Clarke BF. The value of cardiovascular autonomic function tests: 10 years experience in diabetes. Diabetes Care. 1985 Sep-Oct;8(5):491-8. doi: 10.2337/diacare.8.5.491.
• Casellini CM, Parson HK, Richardson MS, Nevoret ML, Vinik AI. Sudoscan, a noninvasive tool for detecting diabetic small fiber neuropathy and autonomic dysfunction. Diabetes Technol Ther. 2013 Nov;15(11):948-53. doi: 10.1089/dia.2013.0129. Epub 2013 Jul 27.
• Yajnik CS, Kantikar VV, Pande AJ, Deslypere JP. Quick and simple evaluation of sudomotor function for screening of diabetic neuropathy. ISRN Endocrinol. 2012;2012:103714. doi: 10.5402/2012/103714. Epub 2012 Jul 9.
• Grandinetti A, Chow DC, Sletten DM, Oyama JK, Theriault AG, Schatz IJ, Low PA. Impaired glucose tolerance is associated with postganglionic sudomotor impairment. Clin Auton Res. 2007 Aug;17(4):231-3. doi: 10.1007/s10286-007-0426-z. Epub 2007 Aug 23.
• Low VA, Sandroni P, Fealey RD, Low PA. Detection of small-fiber neuropathy by sudomotor testing. Muscle Nerve. 2006 Jul;34(1):57-61. doi: 10.1002/mus.20551.
• Unal-Cevik I, Sarioglu-Ay S, Evcik D. A comparison of the DN4 and LANSS questionnaires in the assessment of neuropathic pain: validity and reliability of the Turkish version of DN4. J Pain. 2010 Nov;11(11):1129-35. doi: 10.1016/j.jpain.2010.02.003. Epub 2010 Apr 24.
• Selvarajah D, Cash T, Davies J, Sankar A, Rao G, Grieg M, Pallai S, Gandhi R, Wilkinson ID, Tesfaye S. SUDOSCAN: A Simple, Rapid, and Objective Method with Potential for Screening for Diabetic Peripheral Neuropathy. PLoS One. 2015 Oct 12;10(10):e0138224. doi: 10.1371/journal.pone.0138224. eCollection 2015.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2014
• Primary Completion (ACTUAL): July 15, 2015
• Study Completion (ACTUAL): July 15, 2015

Study Registration Dates

• First Submitted: March 20, 2022
• First Submitted That Met QC Criteria: March 20, 2022
• First Posted (ACTUAL): March 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac Autonomic Neuropathy; SUDOSCAN; Neuropathy Autonomic; Diabetic Neuropathy Peripheral; Type2Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: 2014/495

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No