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The BRIGHT Study (Device Name: HALO System)

NCT07745998 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-04

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus - Type 1
  • Diabetes Mellitus - Type 2
  • Diabetes Mellitus
  • Ketoacidosis, Diabetic
  • Hyperglycaemia (Diabetic)
  • Hypoglycemia (Diabetic)

Interventions

DEVICE

The HALO System

The FUSHO3 sensor, which is part of the HALO System, is a continuous multi-metabolite monitoring (CMM) sensor which is a miniaturized near-infrared spectrometer that measures the absorption of light in the interstitial fluid to quantify the concentration of multiple metabolites

Sponsors & Collaborators

  • Indigo Diabetes NV

    lead INDUSTRY

Principal Investigators

  • Christophe De Block, Prof. dr. · University Hospital, Antwerp

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-31
Primary Completion
2027-06-30
Completion
2027-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07745998 on ClinicalTrials.gov