Blood Glucose Monitoring System Designed for Accuracy

Recently more attention has been drawn to the accuracy requirements for blood glucose monitoring systems (BGMS) for home use as well as those for hospital use.

Tighter accuracy criteria are being introduced internationally for BGMS and therefore newer systems need to be evaluated for point-of-care testing (POCT) of blood glucose, a valuable biomarker for the management of patients with diabetes and other conditions.

Collaborating scientists from three different institutions and the commercial manufacturer evaluated a BGMS in a multicenter study for precision, interference, and system accuracy using 503 blood samples from capillary, venous, and arterial sources. Included in the study was interference testing, both hematocrit and other substances, and accuracy evaluations. The institutes were the Rainier Clinical Research Center (Renton, WA, USA), the Duke University Medical Center (Durham, NC, USA), and MassResearch LLC (Waltham, MA, USA).

The FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System (Abbott Diabetes Care; Alameda, CA, USA) is designed to simplify POCT for healthcare professionals, providing features that enhance the reliability of the testing process and support compliance with POCT policies. The FreeStyle Precision Pro blood glucose-test strip is individually sealed, and each test strip contains three electrodes, working, reference, and fill trigger. The circuit between the fill trigger and the reference electrodes must be detected by the meter before the test will start. The minimum sample volume required is 0.6 μL and the test time is five seconds.

The FreeStyle Precision Pro system demonstrated acceptable precision, no interference across a hematocrit range of 15% to 65%, and, except for xylose, no interference from 24 of 25 potentially interfering substances. From the individual results of various blood sample types, 97.3% to 98.9% agreed within ±12 mg/dL of the laboratory analyzer values at glucose concentrations less than 100 mg/dL and within ±12.5% of the laboratory analyzer values at glucose concentrations equal to or greater than 100 mg/dL.

The authors concluded that the FreeStyle Precision Pro system makes more measurements and uses more signals from the glucose electrochemical reaction to increase accuracy; it also performs more integrity checks to detect potential errors during each glucose test. The study was published on June 5, 2013, in the journal Clinica Chimica Acta.

Related Links:
Rainier Clinical Research Center
Duke University Medical Center
Abbott Diabetes Care