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

Completed

• Conditions: Neuropathy
• Interventions: Diagnostic Test: Neuropathy measurement

• Registration Number: NCT05178459
• Lead Sponsor: Withings

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2021-12-15
• Study First Posted: 2022-01-05
• Study Start: 2022-03-11
• Primary Completion: 2022-07-22
• Study Completion: 2022-08-08
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neuropathic without diabetes	Neuropathy measurement	Patient diagnosed with neuropathy without diabetes
Diabetic	Neuropathy measurement	Patient diagnosed with diabetes

Primary Outcome Measures

Name	Time	Method
Sudomotor dysfunction diagnostic performance evaluation	10 months	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).

Secondary Outcome Measures

Name	Time	Method
Evaluate the accuracy of Withings WBS08 to measure the sudomotor function on each foot and by averaging the value on both feet.	10 months	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.
Compare the diagnostic of Withings WBS08 to diabetes neuropathy questionnaires	10 months	The correlation between diabetes neuropathy questionnair es and Withings WBS08.
Safety use of this device	10 months	The rate of adverse effects.

Trial Locations

Locations (4)

Lariboisière Hospital; 🇫🇷 Paris, Île-de-France, France

Henri-Mondor Hospital; 🇫🇷 Créteil, Île De France, France

Bichat-Claude Bernard Hospital; 🇫🇷 Paris, Ile-de-France, France

Cochin Hospital; 🇫🇷 Paris, Île De France, France