The BRIGHT Study (Device Name: HALO System)

NCT07745998 | Not Yet Recruiting

• 1 other identifier: IND009
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

CMM; CGM; Diabetes mellitus - type 1; Diabetes mellitus - type 2; ketoacidosis, diabetic; continuous multi-metabolite monitoring; hyperglycaemia (diabetic); hypoglycaemia (diabetic)

Outcome Measures

Primary Outcomes (4)

• Primary performance objective: Demonstration of Sensor accuracy

  Evaluate the accuracy of the Algorithm with an in-factory-calibrated on-sensor model used by the Sensor to generate blood glucose, ketone and lactate concentration values by comparing these values to those of a venous blood reference method and develop an upgraded Algorithm to increase the accuracy of the HALO System by off-sensor model optimisations, using real-time insights and historical experimental data.

  3 months

• Primary performance objective: Demonstration of Sensor stability

  confirm the accuracy of the Algorithm for glucose, ketones and lactate throughout 3 months of implantation, compared to blood reference measurements using an in-factory-calibrated on-sensor model AND using an optimised off-sensor model.

  3 months

• Primary safety objective: Confirm safe implantation of the Sensor in human subcutaneous tissue (insertion procedural safety)

  Incidence of Sensor insertion procedure-related SAEs within 30 days from implantation.

  30 days

• Primary safety objective: Confirm the safety of the device during the implantation period

  Assessment of device-related AEs during 3 months of implant use and all SAEs collected throughout the study.

  3 months

Secondary Outcomes (2)

• Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure

  30 days

• Secondary performance objective: Confirm safe explantation of the Sensor from human subcutaneous tissue (removal procedural safety)

  14 days

Other Outcomes (2)

• Exploratory study objective: Compare daily measurement performance to the participant's standard CGM system.

  3 months

• Participant and Surgeon Usability and Satisfaction Assessed via the HALO Usability Test Form

  3 months

Study Arms (1)

The HALO System

EXPERIMENTAL

Device: The HALO System

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

The HALO System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing not to insert their standard CGM and/or insulin pump in and around the SENSOR implant site (± radius 5 cm)\[TS\| XR1.1\] Diagnosed with type 1 diabetes mellitus according to the World Health Organization criteria, for at least 12 months prior to screening, on CSII therapy

You may not qualify if:

• 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
• Female participants who are pregnant, planning on becoming pregnant or nursing
• Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).
• Anemia identified by a haemoglobin \<14 g/dL for men or \<12 g/dL for women
• The presence of any other active implanted device
• The presence of any other CGM sensor/pump located in the lower abdomen (other location is acceptable)
• Waist circumference of \>120 cm
• Any disorder, which in the investigator's opinion might jeopardise participants' safety or compliance with the protocol.

Sponsors & Collaborators

• Indigo Diabetes NV: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetic Ketoacidosis; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Study Officials

• Christophe De Block, Prof. dr.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gijs Klarenbeek, Dr.

CONTACT

479 98 64 58; gijs.klarenbeek@indigomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-08