The Diabetes Control and Complications Trial (DCCT) clearly demonstrated the importance of tight glycemic control in delaying the onset and progression of diabetic complications. Yet despite frequent self- monitoring of blood glucose (SMBG), intensively managed Type 1 patients exhibited a 3 fold increase in the occurrence of severe hypoglycemia primarily due to the fact that glucose level are dynamically changing in this patient population. Consequently, a method of non-invasive and/or continuous monitoring of glucose is a recognized need by patients, healthcare providers and the U.S. Congress.
The aim of this application is to develop a long-term glucose monitoring system. The technical approach combines chemistry, biomaterials, medical photonics, electronics, and packaging. The proprietary platform technology relies upon passive optochemical transduction and amplification of the in-vivo glucose level for optical detection. In the proposed system, a small amount of optically transducing material within a biocompatible matrix is implanted subdermally or subcutaneously, and interrogated optically through the skin of the patient with a small pager of wrist-watch size external device. After implantation of the amplifying material, the system operates noninvasively without the need for sophisticated optics and complicated algorithms for glucose determination. The long-term objective of this research is to ultimately utilize the continuous monitor in a closed-loop system (electronic beta cell) which would provide patients with automated, near euglycemic control without the fear of hypoglycemia. Based upon the results of the DCCT, it is likely that the successful development of this technology would play a significant role in improving patients' quality of life, dramatically delaying or avoiding diabetic complications, and reducing the staggering health care costs associated with diabetes of more than 100 Billion dollars annually.
