Development of a novel non-antibody based method for measuring the concentration of glycated hemoglobin in blood is proposed. Utilizing only a single measurement, the proposed method will provide a standardized percent HbA1c (glycated hemoglobin A1c) result using a handheld instrument. The method requires only a one-step application of a fingerstick whole blood sample and takes less than 10 minutes. Preliminary data obtained with whole blood samples containing normal (4.3 - 7.0 percent) and high (> 7 percent) HbA1c levels demonstrate the potential of the proposed method. All current point-of-care instruments for HbA1c require more than one step to operate. We believe our proposed method is eligible to receive a CLIA waiver status due to its one-step operation. HbA1c measurement can provide diabetic patients and their healthcare providers an overview of their success in meeting long-term goals for controlling their blood glucose level.
There are more than 10 million diabetics in the United States alone, and the number is expected to grow larger--to 25.3% of the population by year 2005. The American Diabetes Association has recommended monitoring of the hemoglobin A1c level at least four times a year. The potential market for a user-friendly monitoring device is very large. The proposed device is expected to provide a simple, and accurate alternative to the current techniques.