Periodic Reporting for period 2 - MAGIC (Minimally invasive reliAble Glucose monitoring in Intensive Care)
Periodo di rendicontazione: 2023-11-01 al 2025-01-31
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.
GlucoSet has developed a minimally invasive sensor technology which is at the end of the project being tested in patients with good results. In this project, GlucoSet has finalized GlucoSet's technology for use in a medical device so that it can be taken to the market. Market research has shown this is a € 2 billion market opportunity globally, as there are 10 million ICU patients in the US and EU alone each year, and a large fraction of these have elevated 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.
GlucoSet has developed a minimally invasive sensor technology which is at the end of the project being tested in patients with good results. In this project, GlucoSet has finalized GlucoSet's technology for use in a medical device so that it can be taken to the market. Market research has shown this is a € 2 billion market opportunity globally, as there are 10 million ICU patients in the US and EU alone each year, and a large fraction of these have elevated blood sugar.
The project finalized the product development of the two product components (disposable sensor and reusable monitor).This included product development of said components, as well as full verification activities that confirm that the results of the development process were in line with the requirements. Additionally, the system underwent usability and clinical validation activities.
A number of technical problems had to be solved. On the sensor it was necessary to minimise or remove storage degradation, variability, drift, biochemical interferences, and readiness time resulting in a disposable product with a one year lifetime and a one point calibration. The focus on the monitor development were the electrical safety aspects and the signal and data processing. Additionally, signal and data processing needed to be done in real-time. Finally the entire system had to be compliant with critical standards.
The final system was tested with users in a usability trial, in animal trials and in a clinical trial on ICU patients. At the end of the project the trial was still ongoing, although preliminary results were above expectations.
In addition to system safety and performance, the project focused on manufacturability; manufacturing sprints were done throughout the project period, to ensure yield stayed high (≥90%) despite technical optimization of the sensor, and that labour time per sensor went down.
During the project three patent applications have been submitted. These form an important basis for the commercialization of the technology. The patents have been reviewed by the European patent office and only minor modifications had to be done for the PCT applications. A fourth patent application was not ready for submission by the end of the project.
An important achievement in the project was a financing round led by venture capitalist investors. This equity financing was critical to the success of the project.
A number of technical problems had to be solved. On the sensor it was necessary to minimise or remove storage degradation, variability, drift, biochemical interferences, and readiness time resulting in a disposable product with a one year lifetime and a one point calibration. The focus on the monitor development were the electrical safety aspects and the signal and data processing. Additionally, signal and data processing needed to be done in real-time. Finally the entire system had to be compliant with critical standards.
The final system was tested with users in a usability trial, in animal trials and in a clinical trial on ICU patients. At the end of the project the trial was still ongoing, although preliminary results were above expectations.
In addition to system safety and performance, the project focused on manufacturability; manufacturing sprints were done throughout the project period, to ensure yield stayed high (≥90%) despite technical optimization of the sensor, and that labour time per sensor went down.
During the project three patent applications have been submitted. These form an important basis for the commercialization of the technology. The patents have been reviewed by the European patent office and only minor modifications had to be done for the PCT applications. A fourth patent application was not ready for submission by the end of the project.
An important achievement in the project was a financing round led by venture capitalist investors. This equity financing was critical to the success of the project.
The project has yielded an intravascular glucose sensor that
- Measures glucose in blood and shows the measurement in real-time on the monitor
- Has very high accuracy in ICU patients (low to mid single digit MARD)
- Has no significant delay even in very high rates of change
- Has very high trend accuracy (R2 around 0.9)
- Has a short warm-up time
- Is considered easy to use by ICU nurses
- Has a yield of 90% and is manufacturable
Market research on the product indicated that most ICU directors found the product to be highly applicable in their ICU (9 of 10).
- Measures glucose in blood and shows the measurement in real-time on the monitor
- Has very high accuracy in ICU patients (low to mid single digit MARD)
- Has no significant delay even in very high rates of change
- Has very high trend accuracy (R2 around 0.9)
- Has a short warm-up time
- Is considered easy to use by ICU nurses
- Has a yield of 90% and is manufacturable
Market research on the product indicated that most ICU directors found the product to be highly applicable in their ICU (9 of 10).