title: Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting.
abstract: We investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between 50 and 150 mg/dl, whereas 19 (70.3%) met these criteria at BG levels above 250 mg/dl. The overall frequency of outliers was low. The assessment of analytical accuracy of GMS at a number of BG level ranges made it possible to further differentiate between devices with regard to overall performance, a process that is of particular importance given the user-centered nature of the devices' intended use.
authors.affiliation: Diabetesinstitut Heidelberg, Heidelberg, Germany c.hasslacher@diabetesinstitut-hd.de.
authors.forename: Christoph
authors.initials: C
authors.lastname: Hasslacher
authors.affiliation: Diabetesinstitut Heidelberg, Heidelberg, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Kulozik
authors.affiliation: Diabetesinstitut Heidelberg, Heidelberg, Germany.
authors.forename: Isabel
authors.initials: I
authors.lastname: Platten
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy; D004040:Dietary Carbohydrates / Q000008:administration & dosage / Q000378:metabolism; D004867:Equipment Design; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D011237:Predictive Value of Tests; D015203:Reproducibility of Results; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D004040:Dietary Carbohydrates; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: ISO-criteria; accuracy; blood glucose; glucose meter; self-monitoring