Performance Comparison of the GLUCOCARD® Shine and True Metrix® Blood Glucose Monitoring Systems Compared to FDA 2016 Guidance Accuracy Criteria

Presentation Number: SUN 617
Date of Presentation: April 2nd, 2017

Julie Walker*, Patricia Gill, Danielle Maher and John Gleisner
ARKRAY USA, Minneapolis, MN

Abstract

Background: Blood Glucose Monitoring Systems (BGMS) are used in the management of diabetes mellitus. In order to prevent potential micro and macrovascular complications due to uncontrolled blood glucose levels, the systems must provide accurate readings. The FDA’s 2016 Guidance, “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter (OTC) Use”, is FDA’s recommendation for measuring the accuracy of OTC BGMS. The accuracy boundaries of the guidance require that 95% of all results fall within ±15% of reference and 99% within ±20% of reference.

Purpose: This study evaluated the performance of the GLUCOCARD® Shine and True Metrix® BGMS compared to accuracy boundaries of the 2016 FDA Guidance for Self-Monitoring Blood Glucose Test Systems for OTC Use.

Methods: Three lots of both GLUCOCARD® Shine and True Metrix® test strips were evaluated in side-by-side studies at the ARKRAY Factory in Minneapolis, MN. Blood samples were drawn from the fingertip of confirmed diabetics (n=180) by laboratory professionals. Reference values were obtained using the YSI Model 2300 Analyzer. Data was evaluated against the accuracy boundaries of the FDA’s 2016 Guidance for Self-Monitoring Blood Glucose Systems for OTC Use.

Results: For GLUCOCARD® Shine, 99.4% of the combined three lots (179/180) fell within the ±15% of the reference and 100.0% (180/180) were within ±20% of the reference. Overall bias was -0.5% and correlation coefficient (r) = 0.99. For True Metrix®, 95.6% of the three lots (172/180) fell within ±15% of the reference and 99.4% (179/180) were within ±20% of the reference. Overall bias was -3.0% and correlation coefficient (r) = 0.98. Individually, the results for all three lots of GLUCOCARD® Shine and two of the three lots of True Metrix® fell within FDA’s accuracy boundaries.

Conclusion: Based upon our side-by-side testing, GLUCOCARD® Shine had more consistent lot-to-lot performance than True Metrix®.

 

Disclosure: JW: , ARKRAY USA. PG: , ARKRAY USA. DM: Employee, ARKRAY USA. JG: Employee, ARKRAY USA.