DEVELOPMENT OF NON INVASIVE GLUCOSE SENSING DEVICES

描述(摘自申请者摘要)：最近的糖尿病 控制和并发症试验清楚地表明血糖控制 对糖尿病患者来说是至关重要的。的关键组件 强化的糖尿病管理是准确和频繁的血糖监测。 然而，当前一代的家用血糖仪只能准确到/- 15%，需要用手指抽血，必须随身携带 与患者随身携带单独的工具箱。目前的侵入性方法学 表现出患者依从性差，这会导致负面的健康后果 适用于相当大比例的糖尿病患者。我们会 开发一种新型的实时血糖传感器，它是微创的(甚至是 按某些定义是非侵入性的)，它将包含在外脊内 隐形眼镜的，或放置在眼皮下的眼球内的。 这些设备将感知泪液中的葡萄糖水平，这已经被 显示跟踪血液中的葡萄糖水平。该传感材料利用一种 一种含有识别剂的新型聚合胶体阵列材料 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。这种PCCA衍射光的波长确定 通过阵列间距。暴露在葡萄糖中会改变水凝胶的体积 会导致阵列间距发生变化。这改变了衍射光 波长。患者将通过观察来确定他们的葡萄糖浓度 对着镜子里的隐形眼镜；观察到的颜色将准确地给出 他们的葡萄糖浓度。此第一阶段计划中的工作将 证明该传感器的概念证明，通过证明葡萄糖 感知PCCA将在泪液葡萄糖浓度下正常工作 而且不会被泪液中存在的其他物种所混淆。 建议的商业应用：不可用

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