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

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

Study Overview

• Status: Completed
• Conditions: Neuropathy
• Intervention / Treatment: Diagnostic test: Neuropathy measurement

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Paris, Ile-de-France, France, 75018
      • Bichat-Claude Bernard Hospital
  • Île De France
    • Créteil, Île De France, France, 94000
      • Henri-Mondor Hospital
    • Paris, Île De France, France, 75014
      • Cochin Hospital
  • Île-de-France
    • Paris, Île-de-France, France, 75010
      • Lariboisiere Hospital

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: Non-Probability Sample

Study Population

In and out patients from endocrinology and neuropathy departments

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic; Patient diagnosed with diabetes	Diagnostic test: Neuropathy measurement; Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.
Neuropathic without diabetes; Patient diagnosed with neuropathy without diabetes	Diagnostic test: Neuropathy measurement; Patient will step on Withings WBS08 and on the Sudoscan to get their sudomotor dysfunction caused by the neuropathy evaluated.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Withings
• Investigators: Principal Investigator: Louis Potier, Dr, Bichat-Claude Bernard Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: 2021-A02624-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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