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.

NCT Number	NCT07745998
Lead Sponsor	Indigo Diabetes NV
Conditions	Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic, Hyperglycaemia (Diabetic), Hypoglycemia (Diabetic)
Enrollment	12 participants
Start Date	2026-12
Primary Completion	2027-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-04