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
Age ≥ 18 years
Willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate challenges)
Willing to charge the SENSOR on daily basis
Known allergy to polydimethylsiloxane (PDMS)
A contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)
History of hepatitis C or HIV or other disease transmissible by blood
A condition requiring or likely to require magnetic resonance imaging during the study duration