Devin A Sicard1, James R Taylor. 1. Department of Pharmacy Practice, College of Pharmacy, University of Florida, Gainesville, FL 32610-0486, USA.
Abstract
BACKGROUND: Glycosylated hemoglobin (HbA1c) evaluation is an accepted standard of care for assessing diabetes control. Point-of-care HbA1c monitors are relatively new, and there are few published data on their accuracy. OBJECTIVE: To compare a point-of-care HbA1c monitor with standardized laboratory testing. METHODS: Twenty-three patients who had type 1 or 2 diabetes were identified from our pharmacy-run diabetes clinic at a primary care clinic as needing HbA1c evaluation based on the American Diabetes Association guidelines. All patients with diabetes who attended our clinic were invited to participate in the study. Patients were required to obtain both a standardized laboratory HbA1c evaluation and a point-of-care A1c Now value within a week of each other. An analysis evaluating both clinical and statistical significance was completed at the end of the study. RESULTS: The A1c Now monitor showed good correlation (r = 0.758) to the standardized laboratory test. We found that the most accurate A1c Now values were within a range of 6-8%. One patient's value would have resulted in a different clinical decision if the decision were based on the A1c Now value. CONCLUSIONS: It appears that A1c Now may provide adequate accuracy and be useful for some patients. The monitor would be most beneficial for patients who cannot obtain standardized laboratory values secondary to either financial or transportation constraints. However, the decision to make adjustments in therapy should not be based solely on the A1c Now point-of-care result.
BACKGROUND: Glycosylated hemoglobin (HbA1c) evaluation is an accepted standard of care for assessing diabetes control. Point-of-care HbA1c monitors are relatively new, and there are few published data on their accuracy. OBJECTIVE: To compare a point-of-care HbA1c monitor with standardized laboratory testing. METHODS: Twenty-three patients who had type 1 or 2 diabetes were identified from our pharmacy-run diabetes clinic at a primary care clinic as needing HbA1c evaluation based on the American Diabetes Association guidelines. All patients with diabetes who attended our clinic were invited to participate in the study. Patients were required to obtain both a standardized laboratory HbA1c evaluation and a point-of-care A1c Now value within a week of each other. An analysis evaluating both clinical and statistical significance was completed at the end of the study. RESULTS: The A1c Now monitor showed good correlation (r = 0.758) to the standardized laboratory test. We found that the most accurate A1c Now values were within a range of 6-8%. One patient's value would have resulted in a different clinical decision if the decision were based on the A1c Now value. CONCLUSIONS: It appears that A1c Now may provide adequate accuracy and be useful for some patients. The monitor would be most beneficial for patients who cannot obtain standardized laboratory values secondary to either financial or transportation constraints. However, the decision to make adjustments in therapy should not be based solely on the A1c Now point-of-care result.
Authors: Shiela M Strauss; Mary Rosedale; Michael A Pesce; Caroline Juterbock; Navjot Kaur; Joe DePaola; Deborah Goetz; Mark S Wolff; Dolores Malaspina; Ann Danoff Journal: Point Care Date: 2014-12