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）：第一阶段提案的目标是证明将一种新型创新胰岛素测定法集成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，B) 作为使用胰岛素输注泵的糖尿病患者的反馈控制。这项技术的重要性基于以下事实：糖尿病（主要是 2 型糖尿病）在全球范围内的患病率持续上升，目前的预测表明至少在未来四分之一个世纪内，全球患病率将持续上升。众所周知，胰岛素抵抗经常与肥胖相伴，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划分为胰岛素敏感或抵抗，或者轻度、中度、 或胰岛素分泌严重受损。目前，胰岛素敏感性和分泌的测量仅用于研究目的，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 型糖尿病患者数量（目前美国约 200,000 名用户或约 5%）将在不久的将来增加。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将进一步加速胰岛素泵的广泛使用。然而，当前的泵技术没有提供任何方法来量化进入血流的胰岛素量。如果插入针由于放置不当或疤痕组织而无法输送胰岛素，这可能会对使用者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度突然增加可能会导致进入体内的胰岛素过量而致命。由于当前的商业胰岛素检测技术具有显着的缺点，例如体积大、硬件和测定组件的成本高，因此仍然非常需要一种经济的胰岛素测定法，该测定法可以合并到一个小型设备中，以便在医生办公室或什至在家中使用，以评估胰岛素敏感性，和/或量化血液中输注胰岛素（用泵）的实际浓度。因此，BioTex, Inc 提议开发急需的快速且用户友好的胰岛素检测方法，用于临床医生办公室（护理点）。 公共健康相关性：第一阶段提案的目标是证明一种新型创新胰岛素检测方法集成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，B) 作为使用胰岛素输注泵的糖尿病患者的反馈控制。这项技术的重要性基于以下事实：糖尿病（主要是 2 型糖尿病）在全球范围内的患病率持续上升，目前的预测表明至少在未来四分之一个世纪内，全球患病率将持续上升。 由于当前的商业胰岛素检测技术具有显着的缺点，例如体积大、硬件和测定组件的成本高，因此仍然非常需要一种经济的胰岛素测定法，该测定法可以合并到一个小型设备中，以便在医生办公室或什至在家中使用，以评估胰岛素敏感性，和/或量化血液中输注胰岛素（用泵）的实际浓度。因此，BioTex, Inc 提议开发急需的快速且用户友好的胰岛素检测方法，用于临床医生办公室（护理点）。