Clinical Utility of SUDOSCAN in the Pediatric Population

Impeto Medical

Status: Withdrawn

Conditions: Prediabetes; Diabetes; Childhood Obesity

Study type: Observational

Funder types: Industry

Identifiers

NCT02216201

Impeto-015

Details and patient eligibility

About

The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population.

Primary Objective: To measure sweat gland function in a pediatric population

Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland function in the pediatric population

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females ages 8 to 17 years
• Able to give assent as well as parental consent

Exclusion criteria

• History of type 1 or type 2 diabetes
• Chronic autoimmune condition
• Taking chronic immunosuppressive or anti-inflammatory medications
• Unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute Sudoscan test
• Presence of hepatitis B or C
• Presence of HIV
• Presence of known neurological disorder
• Pregnancy and/or breastfeeding
• Any open wound on the soles of the feet or palms of the hands
• Participation in an ongoing clinical investigational drug trial
• Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study