title: Performance of a new blood glucose monitoring system in the hands of intended users.
abstract: BACKGROUND
  This study assessed the performance of a blood glucose monitoring system (BGMS) in development that uses a new generation of blood glucose test strips with capillary and venous blood in the hands of its intended users, people with diabetes and healthcare professionals (HCPs).
  
  
  METHODS
  In total, 93 subjects ≥ 18 years old (median age, 33 years) with type 1 (78%) or type 2 (22%) diabetes participated. Untrained subjects performed self-test fingersticks using a Microlet(®)2 lancing device (Bayer HealthCare LLC, Diabetes Care, Tarrytown, NY) followed by testing of their own capillary blood on the BGMS. HCPs performed fingersticks (using a Tenderlett(®) lancing device [International Technidyne Corp., Edison, NJ]) and venipunctures on subjects and tested both capillary and venous samples from subjects on the BGMS. All BGMS results were compared with Yellow Springs Instruments (YSI) (YSI Life Sciences, Inc., Yellow Springs, OH) laboratory results. Analytical accuracy was assessed according to International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., within ± 15 mg/dL or ± 20% of the YSI results for samples with glucose concentrations < 75 mg/dL and ≥ 75 mg/dL, respectively) and more stringent criteria (i.e., within ± 15 mg/dL or ± 15% of the YSI results for samples with glucose concentrations < 100 mg/dL and ≥ 100 mg/dL, respectively).
  
  
  RESULTS
  Overall, 98.9% (180/182) of subject Microlet2 capillary fingerstick results, 99.5% (182/183) of HCP Tenderlett capillary fingerstick results, and 100% (186/186) of venous results met current ISO criteria and more stringent criteria. The average hematocrit was 44%, with values ranging from 32% to 52%.
  
  
  CONCLUSIONS
  Test results from both capillary fingerstick and venous samples with a new BGMS in development met current accuracy guidelines as well as proposed tighter criteria.
authors: AMCR Institute Inc, Escondido, California 92026, USA. tbailey@amcrinstitute.com
authors: Timothy S
authors: TS
authors: Bailey
authors: Jane F
authors: JF
authors: Wallace
authors: Joan Lee
authors: JL
authors: Parkes
authors: Scott
authors: S
authors: Pardo
authors: Ji
authors: J
authors: Yu
authors: Holly C
authors: HC
authors: Schachner
authors: David A
authors: DA
authors: Simmons
authors: Amy
authors: A
authors: Chu
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000453:epidemiology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000453:epidemiology; D005260:Female; D006400:Hematocrit / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D014481:United States / Q000453:epidemiology; D055815:Young Adult
chemical_list: D001786:Blood Glucose