Accuracy and Precision of the Prodigy AutoCode Blood Glucose Monitor

Abstract

Objectives: To assess the accuracy and precision of the Prodigy AutoCode blood glucose monitor. Methods: This open-label, prospective equivalence study was conducted at Wilson Community Health Center in Wilson, North Carolina. Accuracy was assessed by comparing finger stick blood glucose values to venipuncture. Precision was assessed by comparing consecutive finger stick blood glucose values from 2 Prodigy AutoCode monitors. Data were analyzed using paired t tests, signed rank tests, regression, and mixed effect models. Results: Fifty-three subjects completed the study. Meter 1 produced 14 (26%) and meter 2 produced 13 (25%) blood glucose readings outside the acceptable error margin of ±20% set by the International Organization for Standardization (ISO) and the Food and Drug Administration (FDA). Neither meter was accurate compared to venipuncture (P < .001 for both). Consecutive blood glucose results obtained from meters 1 and 2 were precise (meter 1 vs 2, P = .533). Conclusions: The Prodigy AutoCode demonstrated precision between two different monitors but was inaccurate compared to venipuncture. Less than the required 95% of blood glucose values from each monitor fell within the acceptable 20% error margin relative to venipuncture. All readings outside the acceptable error margin were overestimations, indicating potentially significant safety concerns including untreated or undertreated hypoglycemia.

Keywords

ambulatory care diabetes mellitus blood glucose self-monitoring Prodigy AutoCode

Get full access to this article

View all access options for this article.

References

American Diabetes Association. Standards of medical care in diabetes 2011. Diabetes Care. 2011;34(suppl 1):S11–S61.

American Diabetes Association. Standards of Medical Care in ISO 15197:2003-05-01: In Vitro Diagnostic Test Systems. Requirements for Blood-Glucose Monitoring System for Self-Testing in Managing Diabetes Mellitus. Reference number ISO 15197:2003 (E). Geneva: International Organization for Standardization; 2003.

U.S. Food and Drug Administration, Division of Clinical Laboratory Devices. Review Criteria for Assessment of Portable Invasive Blood Glucose Monitoring in Vitro Diagnostic Devices which use Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology. Rockville, MD: Food and Drug Administration; 1998.

American Diabetes Association. Clinical practice recommendations 1996: self-monitoring of blood glucose. Diabetes Care. 1996;19(suppl 1):S62–S66.

American Diabetes Association. Consensus statement on self-monitoring of blood glucose. diabetes care 1986. Diabetes Care. 1987;10(1):95–99.

Owner’s Manual: Prodigy AutoCode Blood Glucose Monitoring System. Prodigy Diabetes Care, LLC. Charlotte, NC. Last revised September 2009.

Freckmann

Baumstark

Jendrike

. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010;12(3):221–231.

Mahoney

Ellison

. Assessing glucose monitor performance—a standardized approach. Diabetes Technol Ther. 2007;9(6):545–552.

U.S. Food and Drug Administration. MAUDE Adverse Event Report. Report number MW5020638. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2097552. Accessed June 14, 2011.

10.

U.S. Food and Drug Administration. MAUDE Adverse Event Report. Report number MW5015997. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1695621. Accessed June 14, 2011.

11.

U.S. Food and Drug Administration. MAUDE Adverse Event Report. Report number MW5018176. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1899802. Accessed June 14, 2011.

12.

U.S. Food and Drug Administration. MAUDE Adverse Event Report. Report number MW5018745. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1944118. Accessed June 14, 2011.