Withings Introduces Body Pro 2, an Rx Device for Early Detection of DPN*

Smart Scales have traditionally been used by consumers to track their personal wellness metrics. However, Withings saw an opportunity to use highly sophisticated technologies in an at-home setting that provide critical data for providers to make more timely and informed care decisions. Body Pro 2 is that type of technology – a scale that adds both nuance and robustness to at-home health management and has the potential to improve the early detection of diabetic peripheral neuropathies (DPN).

Remote patient monitoring provides immediate, daily measurements to track and manage patient care for at-risk patients. As the creator of the original home smart scale, Withings has 15 years of experience in this field and hundreds of peer-reviewed studies of its products and measurements. In 2022 Withings acquired Sudoscan®, the FDA-cleared medical device for assessing DPN. We have now incorporated the Sudoscan® technology – which is already used by thousands of clinicians around the world – in our Body Pro 2 device.

Rather than hoping patients come for a regular foot exam, doctors and other health professionals can now monitor signs of diabetic peripheral neuropathy with daily readings to detect the earliest changes in small fiber neuropathy, at a stage when interventions can have the most profound effect. With 70% of patients with diabetes suffering from DPN at some point, regular assessment is critical. Unfortunately, annual comprehensive foot exams, as recommended by the ADA, have patient compliance issues and the conventional assessment techniques used by primary care practitioners (PCPs) often miss asymptomatic patients.

Body Pro 2 assesses small fiber nerves by emitting low voltage pulses to stimulate the sweat glands in the foot and measures reactivity to the impulse, providing a quantitative Electrochemical Skin Conductance (ESC) score. An equivalence study compared the ESC measurements of Withings’ at-home device with those of the Sudoscan device which has been used in specialty clinics and hospital settings for more than 10 years (1). The multi-center, cross-sectional study was carried out in four French university hospitals with 147 patients. Results demonstrated an almost perfect agreement in terms of sensitivity, specificity, and repeatability.

Within 60 seconds of stepping on the scale, patients and care teams receive feedback indicating whether small fiber neuropathy may be present. Care teams can then determine, based on the potential extent of the neuropathy, whether ongoing monitoring or immediate referral to a specialist is needed. The data are displayed on the screen and seamlessly transmitted to the care team by cellular, wireless, or bluetooth technology. This connectivity allows the physician to communicate with the patient and provide instructions for care.

Beyond the usual weight and BMI biomarkers, the Body Pro 2 is the first at-home cellular scale to measure body composition using multifrequency Bioelectrical Impedance Analysis (BIA). The body composition readings include fat mass, visceral fat, muscle mass, bone mass, and water percentage. A built-in algorithm, ProgramMemberID, assures that the data are coming from the patient – not a family member – and an engagement score helps a provider adjust advice to the patient accordingly.

Eric Carreel, Founder and President of Withings, commented, “Body Pro 2 allows for early detection of a largely underdiagnosed condition and therefore a better management of the diabetic foot. I also believe that providing access to longitudinal ESC data has the potential to help the industry rethink how we should care for patients with diabetes.”

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1. Riveline JP, Mallone R, Tiercelin C, Yaker F, Alexandre-Heymann L, Khelifaoui L, Travert F, Fertichon C, Julla JB, Vidal-Trecan T, Potier L, Gautier JF, Larger E, Lefaucheur JP. Validation of the Body Scan®, a new Device to detect small fiber neuropathy by assessment of the sudomotor function: agreement with the Sudoscan®. Front Neurol. 2023 Oct 31;14:1256984. doi: 10.3389/fneur.2023.1256984. PMID: 38020587; PMCID: PMC10644320
2. Amit Goel et al., « Comparison of Electrochemical Skin Conductance and Vibration Perception Threshold Measurement in the Detection of Early Diabetic Neuropathy », PLOS ONE 12, no 9 (7 septembre 2017): e0183973, https://doi.org/10.1371/journal.pone.0183973
3. Angelica Carbajal-Ramírez et al., « Early Identification of Peripheral Neuropathy Based on Sudomotor Dysfunction in Mexican Patients with Type 2 Diabetes », BMC Neurology 19, no 1 (31 mai 2019): 109, https://doi.org/10.1186/s12883-019-1332-4
4. Selvarajah D, Cash T, Davies J, Sankar A, Rao G, Grieg M, Pallai S, Gandhi R, Wilkinson ID, Tesfaye S. SUDOSCAN: A Simple, Rapid, and Objective Method with Potential for Screening for Diabetic Peripheral Neuropathy. PLoS One. 2015 Oct 12;10(10):e0138224

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