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.