Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale

Study Overview
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Brief Summary
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The aim of this study is to evaluate the diagnostic performance of Withings WBS08 to screen small fiber neuropathy.

Detailed Description
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Patients with neuropathy are included in hospitals. Each patient will have his neuropathy evaluated with Withings WBS08 and its reference the Sudoscan.

Official Title
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Withings Study to Analyse the Accuracy of Screening Small Fiver Neuropathy With a Bathroom Scale

Conditions
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Neuropathy

Intervention / Treatment
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* Diagnostic Test: Neuropathy measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is an adult, man or woman (18 years old or more) Subjects affiliated or eligible to a social security system Subjects having expressed their consent to take part in the study Two type of patients are included in the study : Patients having diabetes (80% of the inclusion) Non diabetic patients having a lower limbs neuropathy (20% of the inclusion) Exclusion Criteria: Minors under 18 years old Subject is pregnant or trying to get pregnant Subjects having a pacemaker Subjects having refused to give their consent Vulnerable subjects according to the French regulation in force: Individuals deprived of liberty by a court, medical or administrative order Individuals legally protected or unable to express their consent to take part in the study Individuals unaffiliated to or not beneficiary of a social security system Individuals who fit in multiple categories above Individuals linguistically or mentally unable to express their consent Individuals having an lower limb amputation bigger than toes Individuals not able to stand still for a few minutes Individuals under antidepressant medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic<br>Patient diagnosed with diabetes | Diagnostic Test: Neuropathy measurement<br>* Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.<br>|
| Neuropathic without diabetes<br>Patient diagnosed with neuropathy without diabetes | Diagnostic Test: Neuropathy measurement<br>* Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sudomotor dysfunction diagnostic performance evaluation | The diagnostic performance of the Withings WBS08 will be established using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction). | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet. | The root-mean-square error (RMSE) and the mean absolute error (MAE) between the sudomotor function value measured by the Withings WBS08 and the Sudoscan as reference on each foot and by averagin g both feet. | 10 months | 
| Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires | The correlation between diabetes neuropathy questionnair es and Withings WBS08. | 10 months | 
| Safety use of this device | The rate of adverse effects. | 10 months |