Performance analysis of the OneTouch UltraVue blood glucose monitoring system.
BACKGROUND
OneTouch UltraVue is a new meter for self-monitoring of blood glucose that includes a color display, used-strip ejector, and no-button interface. The system uses an electrochemical biosensor technology based on glucose oxidase chemistry to detect glucose concentrations from 20 to 600 mg/dl (1.1 to 33.3 mmol/liter).


METHODS
Accuracy and reproducibility were evaluated over a wide range of glucose concentrations according to standard criteria. Clinical accuracy was assessed by health care providers (HCPs) in two studies and by diabetes patients in the second study. Reference glucose levels were determined by a YSI 2300 analyzer. Same-day reproducibility and day-to-day reproducibility were also evaluated.


RESULTS
In the accuracy studies, 99.7% and 98.7% of tests by HCPs and 97.0% of tests by patients were within +/-15 mg/dl (+/-0.8 mmol/liter) of the YSI reference for blood glucose <75 mg/dl (<4.2 mmol/liter), and within +/-20% for blood glucose > or =75 mg/dl (> or =4.2 mmol/liter), respectively. Consensus error grid analysis showed that 99.7% and 95.3% of tests by HCPs and 97.0% of tests by patients fell within zone A (i.e., has no effect on clinical action); all other results were in zone B (i.e., altered clinical action, little or no effect on clinical outcome). In the reproducibility studies, the standard deviation was <1.5 mg/dl (<0.1 mmol/liter) for glucose concentrations <100 mg/dl (<5.6 mmol/liter), and the coefficient of variation was <2% for concentrations > or = 100 mg/dl (> or =5.6 mmol/liter).


CONCLUSIONS
OneTouch UltraVue meets standard acceptability criteria for accuracy and reproducibility across a wide range of glucose concentrations. Its simple interface and lack of contact with used strips make it a viable option for older patients and their caregivers.
Chang
Anna
A
John Muir Physician Network Clinical Research Center, Concord, California 94520, USA. Anna.Chang_MD@johnmuirhealth.com
Orth
Alice
A
Le
Bryan
B
Menchavez
Perla
P
Miller
Lupe
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D002140:California; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis*; D019719:Diagnostic Equipment; D004867:Equipment Design; D005260:Female; D005949:Glucose Oxidase / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D011237:Predictive Value of Tests; D011934:Reagent Strips; D015203:Reproducibility of Results; D013647:Task Performance and Analysis; D055815:Young Adult
D001786:Blood Glucose; D011934:Reagent Strips; D005949:Glucose Oxidase