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医疗保健问题，正在达到危机的比例，迫切需要新的治疗方法。我们开发了一种长期、完全独立的葡萄糖监测传感器，具有电池供电的遥测功能，可植入皮下组织。该传感器将在1型糖尿病中具有独特的应用，用于低血糖警告，胰岛素剂量和人工胰腺的控制。该传感器还可以应用于2型糖尿病的葡萄糖监测、肥胖症的热量和活动管理以及易感个体的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运行长达520天）后，在第二阶段，我们在6个月的FDA批准的首次人体临床试验中证明了操作。在本临床试验中，植入人体6个月的传感器/遥测单元证明了每次长达1个月的校准稳定性（检查的最长校准间隔）。临床试验还显示，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，并在第二代设备中得到体现，现在可以用于人体研究。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器械的可接受性能，其中将包括传感器准确性和滞后的定量评估。 还将评估传感器在闭环系统中未来应用的潜在效用。长期植入式葡萄糖传感器在糖尿病的治疗中具有重要作用。我们正在开发的传感器经过了系统的工程分析，广泛的长期动物试验和初步的长期人体临床研究。使用第二代传感器的拟议研究旨在促进商业化，并加速将长期传感器交付到广泛的临床实践中。

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.