GlucoSet is developing a blood glucose sensor for critically ill patients. Large clinical trials have shown that better blood sugar control in critically ill patients can provide a significant reduction in dangerous complications, mortality and cost for the hospital, but also that these benefits are very difficult to extract in practice; the balance between too little insulin (no benefit) and too much insulin (harmful to the patient) is difficult to strike if insulin is dosed based on point measurements of blood sugar.
Sensors developed to monitor subcutaneous blood sugar in patients with diabetes have previously been tested in critically ill patients, but consistently show too poor accuracy for these to be used in an intensive care unit. Others have tried to develop intensive care patient sensors without success, as drawing blood often fails because the blood clots in the catheter/tubing, and requiring the patient to have several catheters is clinically unacceptable.
The project successfully developed an improved ICU continuous glucose monitoring (CGM) system with enhanced safety and performance features. A major breakthrough was achieved in reducing interference from common ICU substances, particularly at low glucose levels where accuracy is crucial for patient safety. This was accomplished through modifying the sensor's chemical properties rather than the traditional approach of optimizing the glucose detection mechanism.
The team made significant progress in developing a non-adjunctive CGM sensor that can be used directly for insulin dosing decisions, rather than just as a supplementary tool alongside traditional glucometers. They also created an innovative protective coating that prevents unwanted chemical reactions without causing side effects.
The sensor preparation time was successfully reduced from over 30 minutes to 15 minutes, with potential for further reduction to under 5 minutes with an advanced design. The real-time monitoring capabilities were enhanced through temperature compensation algorithms and material modifications, achieving response times below the target of 5 minutes, which is crucial for potential automated systems.
In terms of compatibility, the team developed a new device design that works with most standard arterial catheters in the European market, significantly exceeding their initial target of 50%. This was achieved through careful analysis of various catheter models and innovative engineering solutions.
The project also included successful in vivo tests that validated most of the laboratory results, though they identified a new challenge regarding calibration time after insertion that requires further investigation. While some work remains before commercial implementation, the project significantly reduced technological risks, making it more attractive to potential investors despite challenging capital market conditions.
The project contributed to several patent applications and plans are in place to publish the in vivo results in a scientific paper by late 2025 or 2026.
In this project, partners GlucoSet and its development/manufacturing partners will have direct financial gains from sales of the product as they are manufacturing Sensors, Monitors and Introducers, respectively. These partners will also gain expertise and experience in this project that can be leveraged in future development projects. NTNU and the academic partner that contributed to the in vivo test stands to gain prestige from scientific publications of the results of their collaborations.
A successful project will accelerate the process of making glucose the next vital sign in intensive care. Given 10m ICU patients in the US and EU, an average mortality risk of 10% and a relative mortality reduction of 24%, the potential is to save lives of hundreds of thousands - and reduce healthcare costs by billions.
GlucoSet utvikler en blodsukkersensor for kritisk syke pasienter. Store kliniske studier har vist at bedre blodsukkerkontroll i kritisk syke pasienter kan gi en betydelig reduksjon i komplikasjoner, dødelighet og kostnad, men også at disse fordelene er svært vanskelig å hente ut i praksis; balansen mellom for lite insulin (ingen nytte) og for mye insulin (økt risiko) er svært vanskelig hvis insulin doseres basert på punktmålinger av blodsukker.
Sensorer utviklet for å monitorere blodsukker i diabetespasienter er prøvd ut i kritisk syke, men viser konsistent alt for dårlig nøyaktighet til at disse kan brukes i intensivavdelingen. Flere har forsøkt å utvikle intensivpasientsensorer uten å lykkes, da det å trekke ut blod ofte feiler pga clotting, og å kreve at pasienten har flere kateter er klinisk uakseptabelt.
GlucoSet har forsket frem en minimalinvasiv sensorteknologi som nå er prøvd ut i mennesker med gode resultater. I dette prosjektet skal GlucoSet utforske om GlucoSets teknologi er tilstrekkelig trygg til at den kan brukes til å trygt dosere insulin i kritisk syke pasienter.
