CONSOLIDATED DIABETES SCREENING DEVICE

DESCRIPTION (provided by applicant): Of the 120 million diabetics in the world, one half are undiagnosed and therefore deprived of the proven benefits of tight glucose control in curbing diabetes-related complications. Recognizing this problem the American Diabetes Association and National Diabetes Data Group advocate screening for undiagnosed diabetes to be an important health-care endeavor. Owing to its high clinical efficiency, the recommended screening test is fasting plasma glucose (FPG>110 mg/dL=impaired fasting glucose; FPG>126 mg/dL=diabetes). This applicant organization proposes to develop a compact, non-instrumented, minimally invasive and virtually painless test tab method designed to visually recognize these FPG cut-off levels. By means of a proprietary capillary architecture, the device doses and transports a blood sample in the nanoliter range to two integrated polymeric detection sites, one for the 110 mg/dL, the other for the 126 mg/dL FPG level. The detection sites embody the dry glucose reagents, as well as a composition capable of absorbing a defined volume of blood plasma while inhibiting cellular component of blood from penetrating the composition. Cellular component is wholly removed from the detection sites by proprietary chemical and physical mechanisms. This obviates the need for a separate cell filtering material, permitting an exceptionally high degree of method miniaturization. Visual recognition of the two cut-off levels is accomplished by a proprietary enzymic redox threshold assay principle. PROPOSED COMMERCIAL APPLICATIONS: The device has the potential to identify by professional, supervised mass, and self-screening millions of undiagnosed diabetics and those with impaired glucose tolerance at risk to develop overt diabetes. Since therapeutic remedies to combat diabetic complications are well established, these people miss out on the opportunity to have their condition recognized and treated, and live healthy productive lives.