The BRIGHT Study (Device Name: HALO System)

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.