Aptamer-based Insulin Detection Device

描述（由申请方提供）：I期提案的目的是证明一种新型和创新胰岛素检测试剂盒整合到小型台式设备中的可行性，重点是临床糖尿病治疗：A）用于评估II型糖尿病患者的胰岛素损伤，以及B）作为使用胰岛素输注泵的糖尿病患者的反馈控制。这项技术的重要性是基于以下事实：糖尿病，主要是2型糖尿病，在全世界的患病率继续增加，目前的预测表明，至少在下一个世纪，世界范围内的患病率将继续上升。胰岛素抵抗通常伴随肥胖，已知是2型糖尿病发病的关键因素。事实上，目前还没有临床标准可以将个体分类为胰岛素敏感或抵抗或患有轻度、中度、 或严重损害胰岛素分泌。胰岛素敏感性和分泌的测量目前仅用于研究目的，并且仅在个别研究中具有可比性。 此外，预计使用胰岛素输注泵的1型糖尿病患者的数量（目前约为1000人）将增加。在美国约有20万用户。5%），在不久的将来会增长。在开发可靠的闭环系统（胰岛素泵+血糖监测仪）方面取得的重大进展应进一步加速胰岛素泵的广泛使用。然而，目前的泵技术没有提供任何手段来量化进入血流的胰岛素的量。在插入针由于不适当的放置或疤痕组织而可能无法输送胰岛素的情况下，这可能对用户的健康造成重大风险。在这两种情况下，少量或根本没有胰岛素可能进入体内，导致血糖升高远高于正常值。更糟糕的是，由于泵故障而导致的胰岛素输注速率的突然增加可能导致致命的过量胰岛素进入体内。由于目前的商业胰岛素检测技术具有显著的缺点，例如尺寸大，以及硬件和测定组件的高成本，因此仍然非常需要一种经济的胰岛素测定，其可以并入到要在医生办公室或甚至在家中使用的小型装置中，用于评估胰岛素敏感性，和/或用于量化血液中输注胰岛素（用泵）的实际浓度。因此，BioTex，Inc建议开发急需的快速和用户友好的胰岛素测定方法，用于临床医生办公室（床旁）。 公共卫生相关性：I期提案的目的是证明一种新型和创新的胰岛素测定方法的可行性，将其集成到小型台式设备中，重点是临床糖尿病治疗：A）用于评估II型糖尿病患者的胰岛素损伤，以及B）作为使用胰岛素输注泵的糖尿病患者的反馈控制。这项技术的重要性是基于以下事实：糖尿病，主要是2型糖尿病，在全世界的患病率继续增加，目前的预测表明，至少在下一个世纪，世界范围内的患病率将继续上升。 由于目前的商业胰岛素检测技术具有显著的缺点，例如大尺寸以及硬件和测定组件的高成本，因此仍然非常需要一种经济的胰岛素测定，其可以并入到要在医生办公室或甚至在家中使用的小型装置中，用于评估胰岛素敏感性和/或用于量化血液中输注的胰岛素（用泵）的实际浓度。因此，BioTex，Inc建议开发急需的快速和用户友好的胰岛素测定方法，用于临床医生办公室（床旁）。

DESCRIPTION (provided by applicant): 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).