Pilot / feasibilityNot yet recruitingNCT07745998
BRIGHT study of the implantable Indigo HALO multi-metabolite sensor
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.
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
Results so far
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.