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Home / Research, Media & Events / Monitoring Diabetic Neuropathy with SUDOSCAN® and Vitamin B12 Supplementation
Follow-up with SUDOSCAN · Scientific publications · Feb 18, 2023

Monitoring Diabetic Neuropathy with SUDOSCAN® and Vitamin B12 Supplementation

Monitoring Diabetic Neuropathy with SUDOSCAN

Monitoring the Effects of Vitamin B12 Supplementation on Diabetic Neuropathy with SUDOSCAN®


T. Didangelos et al.
Article title: Vitamin B12 Supplementation in Diabetic Neuropathy: A 1-Year, Randomized, Double-Blind, Placebo-Controlled Trial.
Nutrients 2021, 13(2), 395.

A recent study conducted by Didangelos et al at Aristotle University of Thessaloniki in Greece investigated the effects of oral vitamin B12 supplementation on patients with type 2 diabetes and diabetic neuropathy (DN). The study aimed to determine if normalizing vitamin B12 levels through oral B12 (methylcobalamin) at a dose of 1 mg/day for one year could alleviate DN symptoms.

DN is a severe complication of type 2 diabetes that can result in debilitating symptoms such as excruciating pain and serious health consequences such as diabetic foot ulcers and amputations. While glycemic therapy is commonly used to manage DN, vitamin B12 supplementation has also been shown to be effective. Vitamin B12 deficiency is common in patients with type 2 diabetes on metformin, and it can accelerate the progression of DN by causing peripheral, autonomic, and painful neuropathy.

The American Diabetes Association recommends that vitamin B12 levels be monitored annually in patients with DN on metformin therapy. In this study, 90 patients with both peripheral and autonomic DN who had been on metformin for at least four years were enrolled in a double-blind placebo-controlled trial. They were randomized to an active treatment group (n=44) receiving B12 or a control group (n=46) receiving a placebo.

The study evaluated several neurophysiological parameters, including sudomotor function measured with SUDOSCAN, pain score, and quality of life.

After 12 months with oral B12 supplementation in type 2 diabetes patients with diabetic neuropathy there were increased plasma B12 levels and significant improvement of all neurophysiological parameters, sudomotor function (SUDOSCAN’s Electrochemical Skin Conductance), pain score, and quality of life. See Table 1.

“SUDOSCAN may be a reliable and early detector of small fiber neuropathy, in addition to diabetic peripheral neuropathy (DPN) and sudomotor dysfunction, all of which are critical factors for the development of the “diabetic foot””.

Table 1: Changes in indices from baseline to follow-up in both groups.
a For difference during follow-up in the active group; b for difference during follow-up in the placebo group; c for difference between groups adjusted for HbA1c and antidiabetic medication.
Abbreviations: HbA1c: glycated hemoglobin; MNSIQ: Michigan Neuropathy Screening Instrument Questionnaire; MNSIE: Michigan Neuropathy Screening Instrument Examination; DQoL: Diabetes Quality of Life Questionnaire; SNAP: sural nerve action potential (amplitude); SNCV: sural sensory nerve conduction velocity; VPT: vibration perception threshold; MCR: mean circular resultant; PI: postural index; Postural hypotension: PO (orthostatic hypotension); Pain: pain score questionnaire; ESCF: electrochemical skin conductance in feet; ESCH: electrochemical skin conductance in hands.
Keywords: diabetic neuropathy; vitamin B12; SUDOSCAN; metformin; diabetic foot; diabetes mellitus; autonomic neuropathy; painful neuropathy.
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Promotional Communication. The medical devices SUDOSCAN® is cleared by the US Food and Drug Administration (FDA). The test allows screening and monitoring of peripheral autonomic neuropathies. It can be performed in diabetic patients or in patients suffering from neurological diseases involving small fibers damage. As with any diagnostic test, its results must be interpreted in a global context including the clinic and other examinations performed. Please read the user manual instructions carefully. Contact our office for more information. Last update: 05/10/2023

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Monitoring Diabetic Neuropathy with SUDOSCAN® and Vitamin B12 Suppleme