Aptamer-based Insulin Detection Device

基于适配体的胰岛素检测装置

• 批准号: 8251039
• 负责人: Ralph Ballerstadt
• 金额: $ 16.28万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-05-01 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8251039
• 关键词: Affinity; Biological Assay; Blood; Blood Glucose; Blood specimen; C-Peptide; Chemistry; Cicatrix; Clinical; DNA; Detection; Development; Devices; Diabetes Mellitus; Diagnostic; Ensure; Enzymes; Evaluation; Feasibility Studies; Feedback; Fluorescence; Funding; Future; Goals; Health; Home environment; Human; Impairment; In Vitro; Individual; Infusion Pumps; Infusion procedures; Insulin; Insulin Infusion Systems; Insulin Resistance; Lead; Ligands; Measurement; Needles; Non-Insulin-Dependent Diabetes Mellitus; Normal Range; Obesity; Overdose; Performance; Phase; Prevalence; Proinsulin; Proteins; Protocols documentation; Pump; Recovery; Research; Resistance; Risk; Sampling; Serum; Small Business Innovation Research Grant; Specificity; Stream; Surface Plasmon Resonance; System; Technology; Testing; Tissues; analog; aptamer; base; cost; cross reactivity; design; diabetes mellitus therapy; diabetic; glucose monitor; improved; innovation; insulin secretion; insulin sensitivity; novel; phase 1 study; point of care; prototype; type I diabetic; user-friendly

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).

描述（由申请人提供）：第一阶段提案的目的是证明一种新的，创新的胰岛素测定法在临床糖尿病治疗中重点关注的小型台式设备中的整合是可行性的：a）评估II型II型糖尿病患者中胰岛素损伤的评估，以及b）作为与糖尿病的反馈对糖尿病的反馈。该技术的重要性是基于以下事实：糖尿病（主要是2型糖尿病）在全球范围内继续增加，而当前的预测表明，至少在下四分之一世纪，全球持续增长。经常伴随肥胖症的胰岛素抵抗是2型糖尿病致病性发育的关键因素。实际上，目前尚无临床标准，可以将一个人归类为胰岛素敏感或抗性，或者具有轻度，中度，中等程度 或严重损害胰岛素分泌。目前仅出于研究目的进行胰岛素敏感性和分泌的测量，并且在个别研究中才具有可比性。 此外，预计使用胰岛素输注泵（目前在美国约20万用户或约5％）的1型糖尿病患者数量将在不久的将来增加。在开发可靠的闭环系统（胰岛素泵 +葡萄糖监测器）方面，应进一步加速胰岛素泵的广泛使用。但是，当前的泵技术没有提供任何量化进入血液的胰岛素量的方法。在插入针头可能由于放置不当或疤痕组织而无法提供胰岛素的情况下，这可能对用户的健康构成重大风险。在这两种情况下，量较小，或根本没有胰岛素可能进入人体，从而导致血糖​​远高于正常值。更糟糕的是，由于泵功能导致的胰岛素输注率突然增加可能导致致命过量的胰岛素进入人体。由于目前的商业胰岛素检测技术具有很大的缺点，例如大小和硬件和测定组件的高成本，因此对于经济的胰岛素测定法，可以将其纳入医生办公室中的小设备中，甚至在家中用于评估胰岛素敏感性，以及/或量化Infused Insulsulin in puppusion flool（in Imply Insulusive in pumpusity in puppusion flow）（或量化pups）。因此，Biotex，Inc建议在临床医生办公室（护理点）开发急需的快速和用户友好的胰岛素测定法。 公共卫生相关性：第一阶段提案的目的是证明一种新的，创新的胰岛素测定法对其在临床糖尿病疗法中重点关注的小型台式设备中的整合起来的可行性：a）评估II型糖尿病患者中胰岛素损伤的可行性，以及b）作为糖尿病与胰岛素Insuliusion pumps pumpss的反馈。该技术的重要性是基于以下事实：糖尿病（主要是2型糖尿病）在全球范围内继续增加，而当前的预测表明，至少在下四分之一世纪，全球持续增长。 由于目前的商业胰岛素检测技术具有巨大的缺点，例如大小和硬件和测定组件的高成本，因此对于经济的胰岛素测定法，可以将其纳入医生办公室中的小设备，甚至在家中用于评估胰岛素敏感性，以及/或用于量化Infused Insulusimulin flower（或量化Insuped Insulsul Insulsim In flow）（或量化puppe）I的小型设备。因此，Biotex，Inc建议在临床医生办公室（护理点）开发急需的快速和用户友好的胰岛素测定法。