Methods and kits for assays of rapid screening of diabetes

Abstract

The invention provides an in vivo screening assay and an in vitro screening assay for rapid screening of diabetes. A method of the invention includes determining a first glucose concentration in an ocular fluid of a patient; administering orally a load of carbohydrate to the patient; determining a second glucose concentration in an ocular fluid of the patient at a period of time of less than 50 minutes after orally administering of the load of carbohydrate; comparing the second glucose concentration with the first glucose concentration to determine if the patient is likely to be a diabetic. The method of the invention is performed by using a kit of the invention. The kit comprises: (1) a glucose-sensing ophthalmic device and instructions for using the glucose-sensing ophthalmic device to screen for diabetes; or (2) two or more tear-collecting devices, and a testing agent composition which specifically reacts with glucose to form a detectable signal. The glucose-sensing ophthalmic device comprises a testing agent composition which specifically and reversibly interacts with glucose to form a detectable optical signal which changes in a concentration-dependent manner.

Description

[0001] This application claims under 35 USC § 119 (e) the benefit of the filing date of U.S. Provisional Patent Application Ser. No. 60 / 427,705 filed Nov. 20, 2002 and all references incorporated therein.[0002] The invention is related to methods and kits for rapid screening of diabetes. BACKGROUND OF THE INVENTION [0003] Diabetes is a serious, lifelong disease which can cause long-term complications that affect almost every part of the body. This disease often leads to blindness, heart and blood vessel disease, strokes, kidney failure, amputations, and nerve damage. Uncontrolled diabetes can complicate pregnancy, and birth defects are more common in babies born to women with diabetes. Diabetes is widely recognized as one of the leading causes of death and disability in the United States. [0004] It is believed that earlier diagnosis and treatment can prevent or delay the costly and burdensome complications of diabetes. Currently, about 5 to 6 million adults in the United States have...

AI Technical Summary

Problems solved by technology

Diabetes is a serious, lifelong disease which can cause long-term complications that affect almost every part of the body.

This disease often leads to blindness, heart and blood vessel disease, strokes, kidney failure, amputations, and nerve damage.

Uncontrolled diabetes can complicate pregnancy, and birth defects are more common in babies born to women with diabetes.

This complicated procedure made detection and diagnosis of diabetes a difficult and cumbersome process.

A fasting blood glucose of 126 mg / dL or greater is the value to diagnose diabetes since this value has been found to be associated with an increased risk of diabetes complications affecting the eyes, nerves, and kidneys.

Although the fasting value can be easily obtained during routine physician visits, in clinics at the place of employment, and other situations, a fasting test may still be inconvenient, uncomfortable, and cumbersome.

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