CLICU - Closed-loop glucose control in the ICU

Glucose control is a problem in intensive care units, and poor glucose control leads to increased mortality, higher complication rates and increased hospital costs. GlucoSet is developing a continuous glucose monitor for the intensive care units, but there is a clear need for the monitor to (at some point) control an insulin infusion pump, as this would give the patient optimal glucose control without disturbing nurses and physicians. To make automated systems creates new challenges - it is unacceptable for automatic systems to increase patient risk. A significant source of risk in the real world is the possibility of human error during calibrations, so it is a condition for an automated system that the system works without human input. A new innovative algorithm for insulin dosing has been developed and tested in silico. New manufacturing methods have also been tested, which can improve the manufacturing process significantly. After the end of the project the work continues in testing the technology in vivo, and building a prototype manufacturing system that implements learnigns achieved in this project, so that further improvements in manufacturing can be achieved.

An outcome of this project was building competence in all partners. GlucoSet’s competence in polymer chemistry, as well as regulation and control, has grown. Persons in SINTEF and NTNU got exposure to the risk management and quality mindset that permeates a medical device company. Relationshi building between GlucoSet, NTNU and SINTEF has already led to new collaborations being explored in 2023. The impact of the project is significant. When the product reaches a 5% market share, it will have been used in 500 000 patients. That would give hospitals net savings of ca €250m/y that could be used to improve health in other ways. With the expected mortality reduction of 30%, 18 000 lives are saved each year, and based on average age at death in the ICU these saved lives would contribute €160m to their local economies.

Blodsukkerkontroll er et problem i intensivavdelinger, og dårlig blodsukkerkontroll fører til økt pasientdødelighet, økt komplikasjonsrisiko og økte sykehuskostnader. GlucoSet utvikler en blodsukkermonitor for intensivavdelingene, men på sikt er det et betydelig behov for at monitoren kan styre en insulinpumpe, slik at pasientens blodsukkerkontroll kan være optimal uten å forstyrre sykepleiere og leger. Å lage automatiske systemer skaper imidlertid nye utfordringer - det er selvsagt uakseptabelt at automatiske systemer skaper mer risiko for pasientene. En betydelig kilde til risiko vil være menneskelige feil i forbindelse med kalibreringer, så det er en forutsetning at systemet fungerer uten menneskelig input. Dette krever en betydelig forskningsinnsats på to fronter. Det må utvikles algoritmer for insulindosering som klarer seg med informasjonen fra glukosesensoren og som kan takle intensivpasientenes ustabile insulinfølsomhet, og produksjonsmetodene til sensoren må forbedres slik at systemet kan drive uten behov for kalibreringer. Prosjektet vil sammen med internasjonalt ledende forskningsmiljøer i Norge og utlandet forsøke å løse disse utfordringene. Prosjektet vil til slutt verifisere løsningen ved å teste en prototype i dyreforsøk.