DEVELOPMENT OF NON INVASIVE GLUCOSE SENSING DEVICES

非侵入式血糖传感设备的开发

• 批准号: 6337106
• 负责人: IGOR K LEDNEV
• 金额: $ 10.01万
• 依托单位: SENTEK GROUP, INC.
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-06-27 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6337106
• 关键词: biomedical equipment development; blood glucose; clinical chemistry; colloids; contact lens; gel; noninvasive diagnosis; patient monitoring device; tear

DESCRIPTION (Scanned from the Applicant's Abstract): The recent Diabetes Control and Complications Trial has clearly demonstrated that glycemic control in patients with diabetes mellitus is crucial. A critical component of intensive diabetes management is accurate and frequent glucose monitoring. However, the current generation of home glucose meters is only accurate to +/- 15 percent, requires a fingerstick for blood sampling, and must be carried as a separate kit everywhere with the patient. The present invasive methodologies show poor patient compliance which translates to negative health consequences for a significant proportion of patients with diabetes mellitus. We will develop a novel, real-time glucose sensor which is minimally invasive (or even by some definitions noninvasive) which will be contained within an outer ridge of a contact lens, or placed within an ocular insert underneath the eyelid. These devices will sense the glucose level in the tear fluid, which has been shown to track the glucose level in blood. The sensing material utilizes a novel polymerized colloidal array (PCCA) material which contains a recognition agent for glucose. The PCCA contains a cubic array of colloidal particles polymerized in a hydrogel. This PCCA diffracts light of a wavelength determined by the array spacing. Exposure to glucose changes the hydrogel volume which results in a change in the array spacing. This alters the diffracted wavelength. The patients will determine their glucose concentrations by looking at their contact lenses in a mirror; the colors observed will accurately give their glucose concentrations. The work here in this Phase I program will demonstrate proof of concept for this sensor by demonstrating that the glucose sensing PCCA will properly function at the tear fluid glucose concentrations and will not be confounded by other species present in the tear fluid. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述（扫描自申请人摘要）：最近的糖尿病 控制和并发症试验已经清楚地表明，血糖控制 对糖尿病患者来说至关重要。的关键组成部分 强化糖尿病管理是准确和频繁的血糖监测。 然而，目前这一代家用血糖仪的精度仅为+/- 15%，需要指尖采血，必须作为 每个地方都有一个单独的工具包。目前的侵入性方法 患者依从性差，导致不良健康后果 对于相当大比例的糖尿病患者来说。我们将 开发一种新颖的实时葡萄糖传感器，其是微创的（或者甚至 根据某些定义为非侵入性的），其将被包含在外脊内 接触透镜，或置于眼睑下的眼插入物内。 这些设备将感测泪液中的葡萄糖水平， 用来追踪血液中的葡萄糖水平。传感材料利用了 一种新型聚合胶体阵列（PCCA）材料， 葡萄糖制剂。PCCA包含胶体颗粒的立方体阵列 在水凝胶中聚合。该PCCA衍射波长确定的光 由数组间距。暴露于葡萄糖会改变水凝胶的体积， 导致阵列间距的变化。这改变了衍射 波长患者将通过观察 在他们的隐形眼镜在镜子里;观察到的颜色将准确地给出 他们的葡萄糖浓度。第一阶段的工作将 通过证明葡萄糖 感知PCCA将在泪液葡萄糖浓度下适当地起作用 并且不会被泪液中存在的其它物质混淆。 拟议商业应用：不可用