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.

Proposed Commercial Applications

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK058523-03
Application #
6608793
Study Section
Special Emphasis Panel (ZRG1-HEM-2 (10))
Program Officer
Jones, Teresa L Z
Project Start
2002-07-08
Project End
2005-06-30
Budget Start
2003-07-01
Budget End
2005-06-30
Support Year
3
Fiscal Year
2003
Total Cost
$317,886
Indirect Cost
Name
Portascience, Inc.
Department
Type
DUNS #
009762050
City
Moorestown
State
NJ
Country
United States
Zip Code
08057