Clinical Evaluation of a Long Term Implanted Glucose Sensor

描述(由申请人提供)：糖尿病是一个正在达到危机程度的主要医疗问题，迫切需要新的治疗方法。我们已经开发了一种长期的、完全自给自足的血糖监测传感器，它带有电池供电的遥测功能，用于皮下组织植入。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。该传感器还可用于2型糖尿病的血糖监测、肥胖症的卡路里和活动管理，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。在这个项目的第一阶段进行了广泛的临床前验证，包括长达520天的动物植入手术后，在第二阶段，我们在为期6个月的FDA批准的第一个人类临床试验中展示了手术。在这项临床试验中，传感器/遥测单元在人体内植入六个月后，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)。临床试验还显示，需要对传感器设计进行几次简单但有价值的修改，这些修改已经完成，并在第二代设备中体现出来，现在已经准备好供人类研究。在拟议的项目中，我们将在为期6个月的人类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准确性和滞后的定量评估。 还将评估该传感器未来在闭环系统中应用的潜在用途。长期植入式葡萄糖传感器在糖尿病的治疗中具有重要的作用。我们正在开发的传感器经过了系统工程分析、广泛的长期动物试验和初步的长期人体临床研究。第二代传感器的拟议研究旨在催化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.