Pilot Study of Insertable, Subcutaneous Catheter

This is a pilot study of insertable, subcutaneous catheter-based glucose sensor developed by the TRIB Biosensors, Inc. The project includes short-term and long-term testing of the catheter in pigs and has two aims:

Aim 1. Short-term testing of the sensor. The short-term testing will be performed in a one-day protocol. The short-term testing is necessary to assess accuracy of the continuous glucose monitoring (CGM) sensor during glucose and insulin injections that will be performed to vary glucose concentration within physiological range of glucose concentration. Up to 8 sensors will be inserted subcutaneously on the back or belly of the pig. The response of those sensors is then monitored over a period of up to 8 hours.

Aim 2. Long-term testing of the sensor. The long-term testing will be performed for 2-to90 days. The long-term testing is necessary to assess accuracy of the CGM sensor over a longer time. No glucose or insulin will be injected and the sensor performance will be analyzed for up to 90 days. The sensor will continuously monitor glucose concentration and transmit data via a wireless interface. The sensor biocompatibility, accuracy, and stability will be assessed in this Aim.