Clinical Evaluation of a Long Term Implanted Glucose Sensor

描述（由申请人提供）：糖尿病是一个主要的健康问题，正在达到危机的程度，迫切需要新的治疗方法。我们已经开发出一种长期的、完全独立的葡萄糖监测传感器，它带有电池操作的遥测技术，可以植入皮下组织。该传感器将在1型糖尿病的低血糖预警、胰岛素剂量和人工胰腺控制方面具有独特的应用。该传感器还可以应用于2型糖尿病的血糖监测，肥胖的热量和活动管理，以及易感人群的2型糖尿病预防。这种长期植入式葡萄糖传感器的开发已经进行了好几年。在该项目的第一阶段进行了广泛的临床前验证，包括在动物植入物中长达520天的操作，在第二阶段，我们在为期6个月的fda批准的首次人体临床试验中展示了该操作。在这项临床试验中，植入人体6个月的传感器/遥测装置一次显示出长达一个月的校准稳定性（所检查的最长校准间隔）。临床试验还表明，需要对几个简单但有价值的传感器设计进行修改，这些修改已经完成，并体现在第二代设备中，现在准备用于人类研究。在拟议的项目中，我们将在为期6个月的人体临床可行性试验中验证第二代设备的可接受性能，其中将包括对传感器精度和滞后性的定量评估。

DESCRIPTION (provided by applicant): Diabetes is a major healthcare problem that is reaching crisis proportions, and new therapies are urgently needed. We have developed a long term, fully self-contained glucose monitoring sensor with battery-operated telemetry for implantation in subcutaneous tissues. The sensor would have unique applications in type 1 diabetes for hypoglycemia warning, insulin dosing, and control of the artificial pancreas. The sensor may also have application for glucose monitoring in type 2 diabetes, caloric and activity management in obesity, and prevention of type 2 diabetes in susceptible individuals. Development of this long term implantable glucose sensor has been underway for several years. Following extensive preclinical validations in the first phase of this project, including operation in animal implants of up to 520 days, in a second phase we demonstrated operation in a 6-month, FDA-cleared, first-in-human clinical trial. In this clinical trial, sensor/telemetry unis implanted in humans for six months demonstrated calibration stability for periods of up to one month at a time (the longest calibration interval examined). The clinical trial also revealed a need for several simple but valuable sensor design revisions, which have been completed and manifested in second generation devices now ready for human study. In the proposed project, we will verify acceptable performance of the second generation devices in a 6-month human clinical feasibility trial, which will include quantitative assessments of sensor accuracy and lag. The potential utility of the sensor for future application in closed-loop systems will also be evaluated. The long term implantable glucose sensor has an important role in the therapy for diabetes. The sensor we are developing has undergone systematic engineering analysis, extensive long term animal tests, and initial long term human clinical study. The proposed studies with the second generation sensor are designed to catalyze commercialization and accelerate delivery of the long term sensor into broad clinical practice.