Belgian diabetes device company Indigo Diabetes has enrolled the first participant in the SHINE clinical trial of its continuous multi-metabolite (CMM) sensor.
The trial’s first participant was enrolled at Antwerp University Hospital (UZA) in Belgium.
The CMM sensor is a small spectrometer-on a-chip designed for monitoring multiple metabolites in-vivo simultaneously and continuously.
It is currently being developed to measure ketone, glucose and lactate levels continuously in diabetes patients.
The device works by measuring the absorption of light in the interstitial fluid to simultaneously quantify the concentration of multiple metabolites without using enzymes or fluorophores.
SHINE is a multi-centre, open-label, prospective, interventional feasibility study that aims to assess the safety of implantation and preliminary performance of the CMM sensor.
In the study, up to 15 participants with diabetes will be recruited across University Medical Centre Ljubljana in Slovenia, Lapeyronie Montpellier University Hospital in France and Antwerp University Hospital in Belgium.
Indigo Diabetes inventor, co-founder, and CEO Danaë Delbeke said: “The start of the SHINE trial is an important milestone for Indigo and follows the successful conclusion of the GLOW trial earlier this year, the results of which we’ve submitted to a peer-reviewed journal for publication.
“Many multi-metabolite monitoring devices under development sit on the skin and are highly visible, which some people do not like because they can feel self-conscious, stigmatised, and uncomfortable.
“Indigo’s continuous multi-metabolite monitor is subcutaneously inserted and is designed to be inconspicuous. We look forward to seeing how it performs in this longer-term stability trial.”
The GLOW trial is the first-in-human clinical study of the sensor.
It comes after Indigo Diabetes raised €38m ($37.3m) in 2020 to fund the development of an ‘invisible’ continuous glucose monitoring device for diabetes.
Founded in 2016, the company aims to provide ‘innovative, high-tech solutions’ for advanced biomarker sensing in diabetes monitoring.