The BRIGHT Study (Device Name: HALO System)

Sponsor
Indigo Diabetes NV
Study ID
NCT07745998
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The HALO System — DEVICE
    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

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Dec 31, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: The HALO System

Primary Outcome Measure

Primary performance objective: Demonstration of Sensor accuracy [ Time Frame: 3 months ]

Central Contacts

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