title: A cross-sectional assessment to detect type 2 diabetes with endothelial and autonomic nervous system markers using a novel system.
abstract: BACKGROUND
  Type 2 diabetes mellitus is frequently unrecognized until complications appear. Diabetic autonomic neuropathy is one of the early complications of type 2 diabetes mellitus, resulting in autonomic nervous system (ANS) dysfunction. The purpose of this study was to determine the validity of ANS function indicators to screen for type 2 diabetes mellitus, as measured by the TM-Oxi and SudoPath system.
  
  
  METHODS
  All enrolled participants completed a basic sociodemographic and medical history questionnaire including current medications. Healthy controls (n = 25) underwent a 2-hour oral glucose tolerance test (OGTT) to evaluate glucose, insulin, and insulin C-peptide. Patients with type 2 diabetes mellitus (n = 24) were assessed with fasting plasma glucose (FPG) and glycosylated hemoglobin. The TM-Oxi and SudoPath system evaluation was completed by all subjects. Data were analyzed using SPSS 22. Frequency and descriptive statistics were calculated on all variables. The criterion for statistical significance was α = 0.05.
  
  
  RESULTS
  The twenty-five healthy controls had a mean age of 37.0 years. The twenty-four type 2 diabetes mellitus patients currently undergoing standard treatment had a mean age of 48.9 years. Based on the American Diabetes Association guidelines, we detected pre-diabetes in 4 subjects and diabetes in 1 subject, while all other subjects had normal FPG values. At 120 minutes, the correlations between the OGTT and cardiometabolic risk score (CMRS) were: r = 0.56 (p = 0.004) for glucose and r = 0.53 (p = 0.006) for insulin. At 120 minutes, the correlations between the OGTT and photoplethysmography index (PTGi) were: r = -0.56 (p = 0.003) for glucose and r = -0.41 (p = 0.04) for insulin. The CMRS, PTGi, and plethysmography total power index (PTGVLFi) differed significantly between the diabetes patients and healthy participants. The specificity and sensitivity for the CMRS, PTGi, and PTVLFi comparing the diabetes patients with healthy controls were high.
  
  
  CONCLUSIONS
  The TM-Oxi and SudoPath system shows promise as a valid, convenient, and non-invasive screening method for type 2 diabetes mellitus. The ANS function and CMR indicators measured by this system may be useful in guiding diabetes and cardiovascular health screening, treatment, and monitoring.
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite #1474 (D28), Miami, FL 33136 USA.
authors.forename: John E
authors.initials: JE
authors.lastname: Lewis
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite #1474 (D28), Miami, FL 33136 USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Lantigua
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite #1474 (D28), Miami, FL 33136 USA.
authors.forename: Steven E
authors.initials: SE
authors.lastname: Atlas
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite #1474 (D28), Miami, FL 33136 USA.
authors.forename: Johanna
authors.initials: J
authors.lastname: Lopez
authors.affiliation: Department of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136 USA.
authors.forename: Armando
authors.initials: A
authors.lastname: Mendez
authors.affiliation: Division of Hospital Medicine, University of Miami Miller School of Medicine, Miami, FL 33136 USA.
authors.forename: Sharon
authors.initials: S
authors.lastname: Goldberg
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite #1474 (D28), Miami, FL 33136 USA.
authors.forename: Sacha
authors.initials: S
authors.lastname: Medici
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite #1474 (D28), Miami, FL 33136 USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Konefal
authors.affiliation: Department of Medicine, University of Miami Miller School of Medicine, Miami, FL 33136 USA.
authors.forename: Judi M
authors.initials: JM
authors.lastname: Woolger
authors.affiliation: Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite #1474 (D28), Miami, FL 33136 USA.
authors.forename: Eduard
authors.initials: E
authors.lastname: Tiozzo
authors.affiliation: Pharmacognosia, Rainier, WA 98576 USA.
authors.forename: Karyem H
authors.initials: KH
authors.lastname: Aliffe
keywords: Autonomic nervous system; Cardiometabolic risk; Diabetic autonomic neuropathy; Glycosylated hemoglobin; Oral glucose tolerance test; Type 2 diabetes mellitus