title: Accuracy of self monitoring blood glucose systems in a clinical setting: application of new planned ISO- standards.
abstract: BACKGROUND
  The accuracy of glucose meters (GMs) for self-monitoring of blood glucose (BG) is essential for preventing insulin dosage errors in insulin injecting diabetic patients. We evaluated the accuracy of 19 commercially available GMs in a clinical setting applying the new planned ISO criteria.
  
  
  METHODS
  Capillary blood was taken at 10-minute intervals in insulin dependent patients during induction of a BG increase and decrease by administration of a standardized carbohydrate rich meal and/or injection of an appropriate dosage of insulin under medical supervision. BG was measured simultaneously by GMs and a laboratory method (Hitado Super GL). The GM results were compared with a laboratory reference method according to the current ISO criteria (ISO 15197:2003) and the proposed (more stringent) criteria.
  
  
  RESULTS
  Evaluating GM results according to the current ISO criteria, all GMs reached the minimum acceptable system accuracy criteria. Analysing GM results according to the more stringent planned ISO standard criteria, only 8 of 19 GMs reached the minimum acceptable accuracy criteria, i.e. > or = 95% of the individual glucose results fell within +/- 15 mg/dL of the results of the reference value at glucose concentrations < 100 mg/dL and within +/- 15% at glucose concentrations > or = 100 mg/dL. When results obtained in BG ranges < and > or = 100 mg/dL were separately analysed, readings of 10 and 8 GMs, respectively, fell in the area of acceptable accuracy.
  
  
  CONCLUSIONS
  The study shows that more than half of the tested GMs would fail the proposed tighter ISO criteria. Most GMs reveal similar accuracy in BG measurement when compared at lower and higher BG ranges.
authors.affiliation: Diabetesinstitut Heidelberg, Germany. c.hasslacher@diabetesinstitut-hd.de
authors.forename: Christoph
authors.initials: C
authors.lastname: Hasslacher
authors.forename: Felix
authors.initials: F
authors.lastname: Kulozik
authors.forename: Isabel
authors.initials: I
authors.lastname: Platten
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood; D006801:Humans; D012015:Reference Standards
chemical_list: D001786:Blood Glucose