Diabetes Mellitus - Type 1NCT07745998
The BRIGHT Study (Device Name: HALO System)
A study testing The HALO System in people with Diabetes Mellitus - Type 1 and Diabetes Mellitus - Type 2, run by Indigo Diabetes NV.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus
- What is being tested?
- The HALO System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The BRIGHT Study, an Open Label, Single-arm, Interventional, Multicenter, Prospective Study of the Diagnostic Feasibility of the HALO System, Designed to Evaluate the Safety and Performance of the HALO SYSTEM in Subjects With Diabetes Mellitus
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.
Read the detailed description
Indigo Diabetes N.V. is currently developing an active implantable medical device, intended to be used for real time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in persons living with diabetes mellitus. The device will be intended for non-adjunctive use and allow integration into hybrid closed loop systems.
In this context, Indigo has developed a first and second prototype, which were used in early feasibility studies in humans (GLOW and SHINE study, respectively). Based on the outcome of these investigations, Indigo developed a third prototype: the HALO SYSTEM, which will be used during the current clinical investigation (BRIGHT study). The system is not substantially similar to any other device currently available on the EU or US markets, since it combines continuous measurement of glucose with continuous ketone (more specifically; β-hydroxybutyrate) and lactate measurement.
After demonstrating safety in previous studies (GLOW and SHINE), the primary intend of the BRIGHT study is demonstrate sensor accuracy and stability througout the study.
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic, Hyperglycaemia (Diabetic), Hypoglycemia (Diabetic)
- Being tested
- The HALO System
- Keywords
- CMM, CGM, Diabetes mellitus - type 1, Diabetes mellitus - type 2, ketoacidosis, diabetic, continuous multi-metabolite monitoring, hyperglycaemia (diabetic), hypoglycaemia (diabetic)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus, Diabetic Ketoacidosis, Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The HALO SystemDevice
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 group | Role | What they receive |
|---|---|---|
| The HALO System | Experimental | Not described Receives: Device: The HALO System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure
- Successful Sensor implantation (first implant in case of re-implant) procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure-related SAEs.
- Successful Sensor explantation procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure-related SAEs.
- Procedural success defined as implantation of the Sensor within an average of 20 minutes (from start incision to closing of skin) without the occurrence of procedure-related AEs up to 30 days after implantation.
- Wound status at each visit.
- Final result on healing at explantation.
Measured: 30 days
Secondary performance objective: Confirm safe explantation of the Sensor from human subcutaneous tissue (removal procedural safety)
Incidence of Sensor removal-related SAEs within 14 days from explantation
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus - Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indigo Diabetes NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe De Block, Prof. dr., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745998
- Sponsor's protocol ID
- IND009
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BRIGHT Study, an Open Label, Single-arm, Interventional, Multicenter, Prospective Study of the Diagnostic Feasibility of the HALO System, Designed to Evaluate the Safety and Performance of the HALO SYSTEM in Subjects With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07745998
- Acronym / sponsor ID
- IND009
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic, Hyperglycaemia (Diabetic), Hypoglycemia (Diabetic)
- Keywords
- CMM, CGM, Diabetes mellitus - type 1, Diabetes mellitus - type 2, ketoacidosis, diabetic, continuous multi-metabolite monitoring, hyperglycaemia (diabetic), hypoglycaemia (diabetic)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Indigo Diabetes NVIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Indigo Diabetes N.V. is currently developing an active implantable medical device, intended to be used for real time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in persons living with diabetes mellitus. The device will be intended for non-adjunctive use and allow integration into hybrid closed loop systems.
In this context, Indigo has developed a first and second prototype, which were used in early feasibility studies in humans (GLOW and SHINE study, respectively). Based on the outcome of these investigations, Indigo developed a third prototype: the HALO SYSTEM, which will be used during the current clinical investigation (BRIGHT study). The system is not substantially similar to any other device currently available on the EU or US markets, since it combines continuous measurement of glucose with continuous ketone (more specifically; β-hydroxybutyrate) and lactate measurement.
After demonstrating safety in previous studies (GLOW and SHINE), the primary intend of the BRIGHT study is demonstrate sensor accuracy and stability througout the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The HALO System | Experimental | Device: The HALO System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The HALO SystemThe 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 | Device | The HALO System |
Primary outcome
Primary performance objective: Demonstration of Sensor accuracy
Time frame: 3 months
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.
Primary performance objective: Demonstration of Sensor stability
Time frame: 3 months
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.
Primary safety objective: Confirm safe implantation of the Sensor in human subcutaneous tissue (insertion procedural safety)
Time frame: 30 days
Incidence of Sensor insertion procedure-related SAEs within 30 days from implantation.
Primary safety objective: Confirm the safety of the device during the implantation period
Time frame: 3 months
Assessment of device-related AEs during 3 months of implant use and all SAEs collected throughout the study.
2 secondary outcomes
Secondary performance objective: Assessment of procedural success for the implantation and explantation procedure
Time frame: 30 days
Secondary performance objective: Confirm safe explantation of the Sensor from human subcutaneous tissue (removal procedural safety)
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe De Block, Prof. dr. principal investigator
University Hospital, Antwerp
Questions about this trial
What is this clinical trial studying?
A study testing The HALO System in people with Diabetes Mellitus - Type 1 and Diabetes Mellitus - Type 2, run by Indigo Diabetes NV.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gijs Klarenbeek, Dr. (479 98 64 58 ext. +32, gijs.klarenbeek@indigomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary performance objective: Demonstration of Sensor accuracy (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.