The objective of the phase I proposal is to demonstrate the feasibility of a new and innovative insulin assay for its integration in a small benchtop device with the focus in clinical diabetes therapy: A) for assessment of insulin impairment in type II diabetics, and B) as feedback control for diabetics with insulin infusion pumps. The significance of this technology is based on the fact that diabetes, primarily type 2 diabetes, continues to increase in prevalence throughout the world and current projections suggest a continued rise worldwide for at least the next quarter century. Insulin resistance, which frequently accompanies obesity, is known to be a key factor in the pathogenic development of type 2 diabetes. In fact, there are currently no clinical criteria by which an individual could be classified as being insulin sensitive or resistant or as having mild, moderate, or severe impairment of insulin secretion. Measurements of insulin sensitivity and secretion are currently done only for research purposes and are only comparable in individual studies. Furthermore, it is anticipated that the number of type 1 diabetics using insulin infusion pumps (currently approx. 200,000 users in the US or approx. 5%) will grow in the near future. Significant progress in developing a reliable closed loop system (insulin pump + glucose monitor) should accelerate the widespread use of insulin pumps further. However, current pump technologies do not provide any means to quantify the amount of insulin entering the blood stream. This can pose major risk to the health of the users in cases where the insertion needle may not deliver insulin due to improper placement, or scar tissue. In both cases, a much smaller amount, or no insulin at all may enter the body, causing the blood sugar to increase far above normal values. Even worse, a sudden increase of insulin infusion rate due to pump-malfunction could lead to a lethal overdose of insulin entering the body. Since current commercial insulin-detection technologies have significant shortcomings, such as large size, and high costs for hardware and assay components, there remains a significant need for an economical insulin assay that can be incorporated into a small device to be used in a doctor's office, or even at home for assessing insulin sensitivity, and/or for quantifying actual concentration of infused insulin (with a pump) in blood. BioTex, Inc therefore proposes to develop much-needed rapid and user-friendly assays for insulin to be used in the clinician's office (point of care). PUBLIC HEALTH RELEVANCE: The objective of the phase I proposal is to demonstrate the feasibility of a new and innovative insulin assay for its integration in a small benchtop device with the focus in clinical diabetes therapy: A) for assessment of insulin impairment in type II diabetics, and B) as feedback control for diabetics with insulin infusion pumps. The significance of this technology is based on the fact that diabetes, primarily type 2 diabetes, continues to increase in prevalence throughout the world and current projections suggest a continued rise worldwide for at least the next quarter century. Since current commercial insulin-detection technologies have significant shortcomings, such as large size, and high costs for hardware and assay components, there remains a significant need for an economical insulin assay that can be incorporated into a small device to be used in a doctor's office, or even at home for assessing insulin sensitivity, and/or for quantifying actual concentration of infused insulin (with a pump) i blood. BioTex, Inc therefore proposes to develop much-needed rapid and user-friendly assays for insulin to be used in the clinician's office (point of care).