Consolidated Diabetes Screening Device

糖尿病综合筛查装置

• 批准号: 6485149
• 负责人: Mary Gaunt-Kloepfer
• 金额: $ 10万
• 依托单位: MICRONIX, INC.
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-01 至 2003-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6485149
• 关键词: biomedical equipment development; blood glucose; diabetes mellitus; diagnosis design /evaluation; electron microscopy; endocrine disorder diagnosis; fasting; metabolism disorder diagnosis; monitoring device; noninvasive diagnosis

DESCRIPTION (provided by applicant): Of the 120 million diabetics in the world, one half are undiagnosed and therefore deprived of the proven benefits of tight glucose control in curbing diabetes-related complications. Recognizing this problem the American Diabetes Association and National Diabetes Data Group advocate screening for undiagnosed diabetes to be an important health-care endeavor. Owing to its high clinical efficiency, the recommended screening test is fasting plasma glucose (FPG>110 mg/dL=impaired fasting glucose; FPG>126 mg/dL=diabetes). This applicant organization proposes to develop a compact, non-instrumented, minimally invasive and virtually painless test tab method designed to visually recognize these FPG cut-off levels. By means of a proprietary capillary architecture, the device doses and transports a blood sample in the nanoliter range to two integrated polymeric detection sites, one for the 110 mg/dL, the other for the 126 mg/dL FPG level. The detection sites embody the dry glucose reagents, as well as a composition capable of absorbing a defined volume of blood plasma while inhibiting cellular component of blood from penetrating the composition. Cellular component is wholly removed from the detection sites by proprietary chemical and physical mechanisms. This obviates the need for a separate cell filtering material, permitting an exceptionally high degree of method miniaturization. Visual recognition of the two cut-off levels is accomplished by a proprietary enzymic redox threshold assay principle. PROPOSED COMMERCIAL APPLICATIONS: The device has the potential to identify by professional, supervised mass, and self-screening millions of undiagnosed diabetics and those with impaired glucose tolerance at risk to develop overt diabetes. Since therapeutic remedies to combat diabetic complications are well established, these people miss out on the opportunity to have their condition recognized and treated, and live healthy productive lives.

描述（由申请人提供）：在世界上1.2亿糖尿病患者中， 一半是未确诊的，因此被剥夺了紧缩的好处。 血糖控制在控制糖尿病相关并发症中的作用。认识到这一点 美国糖尿病协会和国家糖尿病数据组的问题 提倡筛查未确诊的糖尿病是一项重要的保健措施 奋进。由于其高临床效率，推荐的筛查试验 是空腹血糖（FPG>110 mg/dL=空腹血糖受损; FPG>126 mg/dL=糖尿病）。该申请组织提议制定一项契约， 非仪器化、微创且几乎无痛的测试片方法 旨在直观识别这些FPG临界值水平。通过一个 专有的毛细血管结构，该设备的剂量和运输血液 纳升范围内的样品到两个集成的聚合物检测位点，一个 对于110 mg/dL，另一个用于126 mg/dL FPG水平。检测位点 包含干葡萄糖试剂，以及能够吸收 限定体积的血浆，同时抑制血液的细胞成分 渗透到合成物中。细胞成分完全从 通过专有的化学和物理机制检测站点。这消除 需要单独的细胞过滤材料， 方法小型化程度高。视觉识别的两个截止 通过专有的酶促氧化还原阈值测定完成水平测定 原则 拟议的商业应用： 该设备有可能通过专业的、有监督的质量和自我筛查来识别数百万未确诊的糖尿病患者和那些有患显性糖尿病风险的葡萄糖耐量受损患者。由于治疗糖尿病并发症的治疗方法已经很成熟，这些人错过了认识和治疗他们的病情并过上健康富有成效的生活的机会。