Withings clinical study to determine efficacy of its scale in detecting small fiber neuropathy
Withings is about to enter a clinical study to detect whether its recently announced smart scale is able to screen for small fiber neuropathy.
The 5 month study was listed on ClinicalTrials.gov. It is due to begin on March 20th and end on August 20th. The research is looking to recruit 177 participants to test whether Withings scale “WBS08” is able to monitor for small fiber neurophothy. While not listed by name, this is most likely a reference to the scale that was announced at CES 2022 in early January.
To remind, Withings Body Scan is going to be the most advanced bathroom scale you can buy. According to the marketing material, in addition to the standard weight metrics, it will be able to assess nerve activity, detect Afib and monitor segmental body composition.
To this end, the top end of the scale houses a retractable handle. You are meant to hold on to this whilst you are standing on it. Inside the handle are two electrodes, in addition to two more electrodes in the main body of the scale, four weight sensors and 14 ITP electrodes.
Monitoring for small fiber neuropothy
Withings also announced in January that it has acquired Impeto Medical. This is an outfit that specialises in research, development, manufacturing and distribution of medical devices for physicians. Their claim to fame is an FDA-cleared set of standards (SUDOSCAN technology), that is used in detecting and tracking small fiber neuropathy – damage or dysfunction of small fibers of the peripheral nervous system. These are the fibers that detect pain, health and itching on the skin.
Most people with the diagnosis experience a mild form of the condition and do not develop major neurological impairments or disability. But it is often the case that they have other underlying health problems alongside, such as diabetes, Sjögren’s syndrome and lupus. Small fiber neuropathy can also increase the risk of cardiovascular problems reducing a person’s health and life expectancy.
The French outfit is now entering clinical trial to detect the efficacy of the technology in its smart scale. Those participating in the study will either be diagnosed with diabetes and/or neuropathy. They will be required during the research period to regularly monitor for the condition via the Withings scale and on the Sudoscan. The primary outcome of the study is to determine the “diagnostic performance of the Withings WBS08″ by “using the sensitivity and the specificity for an electrochemical skin conductance threshold (moderate dysfunction and severe dysfunction)”.
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The $299 Withings Body Scan scale is not available just yet. The projected release date is the second half of 2022, pending FDA approval. Considering the study is due to conclude in August, it means that September or October could be a potential launch date. We will certainly be looking to get our hands and feet on it when it becomes available, and post a full review.
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