The recent DCCT study has clearly demonstrated that measurement of glycated hemoglobin (GHb) can be used not only to assess long-term glycemia, but also to predict the risk for developing chronic complications in patients with diabetes. Unfortunately GHb testing remains essentially a complex laboratory test. This Phase I study will focus on developing a dry-chemistry, single-use, whole blood test-cartridge for rapid/accurate measurement of GHb using GDS's Stat-Site hand-held reflectance meter. The initial cartridge design will consist of multiple layers that will permit sequentially, lysing of red blood cells, selective binding of non-GHb and the direct passage of the glycated fraction into a bottom detection layer. The color produced by the oxidization of GHb will be measured by the meter, A second cartridge that measures total Hb will be further developed so that % GHb can be calculated. Success of Phase I studies will lead to a modified single test cartridge design capable of simultaneously measuring both total Hb and GHb. This dual test will be developed in Phase II along with appropriate modification of the existing meter. This research will lead to an inexpensive test that measures %GHb in minutes at the point-of-care.Proposed commercial application:An accurate and inexpensive GHb strip- test which can be used in physician's offices as well as at home (similar to current glucose strip-tests) will greatly aid in the management of patients with diabetes. Since GDS's Stat-Site meter is also capable of performing whole-blood glucose and hydroxybutyrate tests, GDS's product line will provide, for the first time, a unique opportunity to measure all the critical glycemic markers on one instrument and thus ensure commercial success.National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
