The BRIGHT Study (Device Name: HALO System)
The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by demonstrating sensor's accuracy and stability and 2) to confirm safe implantation of the Sensor and safety of the device during implantation.
Willing to sign an informed consent form [+4]
Known allergy to polydimethylsiloxane (PDMS) [+10]