Fact CheckerSign in

NCT07745998Not yet recruiting

The BRIGHT Study (Device Name: HALO System)

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

Source: ClinicalTrials.gov · Last updated 4 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
12 (estimated)
First submitted
3 Jul 2026
Start date
Dec 2026
Primary completion date
Jun 2027
Lead sponsor
Indigo Diabetes NV
NCT number
NCT07745998

What you commit to

  • Study type: Interventional
  • Planned participants: 12
  • From Dec 2026 to the primary completion date, Jun 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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
  • Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).
  • Any disorder, which in the investigator's opinion might jeopardise participants' safety or compliance with the protocol.

Lab values

  • Anemia identified by a haemoglobin \<14 g/dL for men or \<12 g/dL for women

Other

  • Female participants who are pregnant, planning on becoming pregnant or nursing
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.