title: Performance and System Validation of a New Cellular-Enabled Blood Glucose Monitoring System Using a New Standard Reference Measurement Procedure of Isotope Dilution UPLC-MRM Mass Spectrometry.
abstract: BACKGROUND
  We evaluated the accuracy, precision, and linearity of the In Touch blood glucose monitoring system (BGMS), a new color touch screen and cellular-enabled blood glucose meter, using a new rapid, highly precise and accurate (13)C6 isotope-dilution liquid chromatography-mass spectrometry method (IDLC-MS).
  
  
  METHODS
  Blood glucose measurements from the In Touch BGMS were referenced to a validated UPLC-MRM standard reference measurement procedure previously shown to be highly accurate and precise. Readings from the In Touch BGMS were taken over the blood glucose range of 24-640 mg/dL using 12 concentrations of blood glucose. Ten In Touch BGMS and 3 lots of test strips were used with 10 replicates at each concentration. A lay user study was also performed to assess the ease of use.
  
  
  RESULTS
  At blood glucose concentrations <75 mg/dL 100% of the measurements are within ±8 mg/dL from the true reference standard; at blood glucose levels >75 mg/dL 100% of the measurements are within ±15% of the true reference standard. 100% of the results are within category A of the consensus grid. Within-run precision show CV < 3.72% between 24-50 mg/dL and CV<2.22% between 500 and 600 mg/dL. The results show that the In Touch meter exceeds the minimum criteria of both the ISO 15197:2003 and ISO 15197:2013 standards. The results from a user panel show that 100% of the respondents reported that the color touch screen, with its graphic user interface (GUI), is well labeled and easy to navigate.
  
  
  CONCLUSIONS
  To our knowledge this is the first touch screen glucose meter and the first study where accuracy of a new BGMS has been measured against a true primary reference standard, namely IDLC-MS.
authors.affiliation: Livongo Health, Inc, Palo Alto, CA, USA kangelides@livongo.com.
authors.forename: Kimon
authors.initials: K
authors.lastname: Angelides
authors.affiliation: Proteomics Programmatic Core Laboratory, Houston Methodist Hospital Research Institute, Houston, TX, USA.
authors.forename: Risë K
authors.initials: RK
authors.lastname: Matsunami
authors.affiliation: Proteomics Programmatic Core Laboratory, Houston Methodist Hospital Research Institute, Houston, TX, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Engler
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D002853:Chromatography, Liquid / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D006801:Humans; D007554:Isotopes; D011865:Radioisotope Dilution Technique; D012015:Reference Standards; D015203:Reproducibility of Results; D053719:Tandem Mass Spectrometry / Q000379:methods
chemical_list: D001786:Blood Glucose; D007554:Isotopes
keywords: In Touch® BGMS; accuracy; blood glucose; isotope dilution mass spectrometry; self-monitoring; standardization