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（从申请人的摘要中扫描）：最近的糖尿病 控制和并发症试验清楚地表明血糖控制 对于糖尿病患者来说至关重要。的一个关键组成部分 强化糖尿病管理是指准确而频繁的血糖监测。 然而，当前一代的家用血糖仪仅精确到 +/- 15%，需要用指尖采血，并且必须作为血样携带 患者随身携带单独的套件。目前的侵入性方法 患者依从性差，这会带来负面的健康后果 对于很大一部分糖尿病患者来说。我们将 开发一种新颖的实时葡萄糖传感器，该传感器是微创的（甚至 根据某些定义，非侵入性）将包含在外脊内 隐形眼镜的一部分，或放置在眼睑下方的眼插入物内。 这些设备将感测泪液中的葡萄糖水平，该水平已被 显示可追踪血液中的葡萄糖水平。传感材料利用 新型聚合胶体阵列（PCCA）材料，其中包含识别 葡萄糖剂。 PCCA 包含胶体颗粒的立方阵列 在水凝胶中聚合。该 PCCA 衍射确定波长的光 通过阵列间距。暴露于葡萄糖会改变水凝胶体积 导致阵列间距发生变化。这改变了衍射 波长。患者将通过观察来确定他们的葡萄糖浓度 在镜子里看自己的隐形眼镜；观察到的颜色将准确地给出 他们的葡萄糖浓度。第一阶段计划的工作将 通过证明葡萄糖来证明该传感器的概念 感测 PCCA 将在泪液葡萄糖浓度下正常发挥作用 并且不会被泪液中存在的其他物质所混淆。 拟议的商业应用：不可用