Clinical evaluation of a novel test strip technology for blood glucose monitoring: accuracy at hypoglycaemic glucose levels.
OBJECTIVE
To evaluate OneTouch® Verio™ test strip performance at hypoglycaemic blood glucose (BG) levels (<3.9 mmol/L [<70 mg/dL]) at seven clinical studies.


METHODS
Trained clinical staff performed duplicate capillary BG monitoring system tests on 700 individuals with type 1 and type 2 diabetes using blood from a single fingerstick lancing. BG reference values were obtained using a YSI 2300 STAT™ Glucose Analyzer. The number and percentage of BG values within ±0.83 mmol/L (±15 mg/dL) and ±0.56 mmol/L (±10 mg/dL) were calculated at BG concentrations of <3.9 mmol/L (<70 mg/dL), <3.3 mmol/L (<60 mg/dL), and <2.8 mmol/L (<50 mg/dL).


RESULTS
At BG concentrations <3.9 mmol/L (<70 mg/dL), 674/674 (100%) of meter results were within ±0.83 mmol/L (±15 mg/dL) and 666/674 (98.8%) were within ±0.56 mmol/L (±10 mg/dL) of reference values. At BG concentrations <3.3 mmol/L (<60 mg/dL), and <2.8 mmol/L (<50 mg/dL), 358/358 (100%) and 270/270 (100%) were within ±0.56 mmol/L (±10 mg/dL) of reference values, respectively.


CONCLUSIONS
In this analysis of data from seven independent studies, OneTouch Verio test strips provide highly accurate results at hypoglycaemic BG levels.
Aston Research Centre for Healthy Ageing, Aston University, Birmingham, UK. s.bellary@aston.ac.uk
Srikanth
S
Bellary
Hillary
H
Cameron
Kirsty
K
Macleod
Michael
M
Malecha
Krisna
K
Koria
Praveen
P
Raja
Jesús Diago
JD
Cabezudo
John
J
Ellison
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000503:physiopathology; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000503:physiopathology; D006801:Humans; D007003:Hypoglycemia / Q000209:etiology*; D008422:Materials Testing; D010044:Outpatient Clinics, Hospital; D011934:Reagent Strips; D015203:Reproducibility of Results; D000078329:Workforce
D001786:Blood Glucose; D011934:Reagent Strips