BRIGHT study of the implantable Indigo HALO multi-metabolite sensor
What this study tests
First registered study of Indigo's HALO implantable sensor, evaluating glucose, ketone and lactate accuracy and stability against venous reference measurements, plus implantation safety, over three months in 12 adults with T1D diagnosed for at least 12 months who use CSII.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-08-04.
Most recent recorded citation date: 2026-08-04. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults with T1D diagnosed for at least 12 months who use continuous subcutaneous insulin infusion (CSII); see registry for full criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. The study is expected to start in December 2026, enrol 12 participants, and complete in June 2027. No study locations are posted yet.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions are not specified here. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Factory-calibrated HALO accuracy for glucose, ketones and lactate versus venous blood reference measurements over three months
- Stability of glucose, ketone and lactate accuracy versus blood reference measurements throughout three months of implantation
- Implantation-procedure safety through 30 days
- Device safety during the three-month implantation period
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT07745998: BRIGHT study of the Indigo HALO System · Trial registry · 2026-08-04 — NOT_YET_RECRUITING; estimated n=12 adults with T1D diagnosed for at least 12 months and using CSII. Primary performance endpoints cover glucose, ketone and lactate accuracy and stability versus venous reference measurements over three months; estimated completion June 2027.