Clinical Evaluation of a Long Term Implanted Glucose Sensor

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 implan