Periodic Reporting for period 2 - GlucoSet (Microsensor for continuous arterial blood glucose monitoring)
Okres sprawozdawczy: 2019-10-01 do 2020-11-30
Most (90%) critically ill patients spontaneously develop hyperglycaemia and increased variability of blood glucose. Meta-analyses of randomized controlled trials show that too poor glucose control in the ICU increases mortality (30%), complication rates (infection 40%, sepsis 40%), and cost. However, outside of clinical trials it is not possible to achieve glucose control safely in the ICU. Intermittent point measurements every few hours do not capture the changes in glucose level. Technology developed for diabetics have consistently failed due to the difficult conditions in ICU patients. Many companies have tried to develop continuous sensors for the ICU market, but all solutions have suffered from being either i) too unreliable or ii) difficult to use in the clinic. GlucoSet is developing the first arterial continuous glucose monitor using a novel sensor technology. The product combines reliability and ease of adoption, directly adressing clinician needs.
The overall objective of the project is to develop the product so that it is ready for CE-mark and commercial use in European hospitals. This will be avchieved by first doing a feasibility study in patients, then making any required revisions to the product based on findings in the feasibility trial, and finally doing a test that gives enough clinical evidence for market access. This is all part of the Horizon 2020 project.
The overall objective of the project is to develop the product so that it is ready for CE-mark and commercial use in European hospitals. This will be avchieved by first doing a feasibility study in patients, then making any required revisions to the product based on findings in the feasibility trial, and finally doing a test that gives enough clinical evidence for market access. This is all part of the Horizon 2020 project.
The initial part of the project focuses on design and engineering of the product so that it is safe enough for testing in patients. This is not trivial for the sensor, as the potential harms from using an invasive device are similar for a first in patient trial and a commercial product. Not only does the product have to be safe, it also has to be manufactured in a controlled environment where it can not be exposed to eg. bacteria that can find their way into patients. The bar is lower for the read-out hardware and software used in a first in patient trial, as the read-outs from the monitor will not be used to make treatment decisions, avoiding the risks that erroneous readings expose the patient to harm. Even before completion of the first-in-patient trial, development work begun on the commercial monitor (hardware and software architecture). A major breakthrough in the project is optimization of the sensor to make it insensitive to interferents that could lead to dangerous situations, making it better than any of the available solutions on the market. This solution will be sought protected by patents and published.
The GlucoSet sensor is posed to be the first continuous glucose monitor of arterial blood in ICU patients. In addition to being unique by monitoring arterial blood, the sensor is insensitive to interferents that could lead to dangerous situations and that plague other glucose monitoring solutions for ICU patients.
The project generated evidence of safe design, high performance and good usability.
The project is expected to have significant socio-economic impact on healthcare costs through the reduced treatment costs of and improved treatment outcomes of ICU patients, although this will not come to pass until after the end of the project.
The project generated evidence of safe design, high performance and good usability.
The project is expected to have significant socio-economic impact on healthcare costs through the reduced treatment costs of and improved treatment outcomes of ICU patients, although this will not come to pass until after the end of the project.