Automatic Control of Blood Glucose Concentration for Intensive Care patients

Project Information

GLUCOSTAT

Grant agreement ID: 777691

DOI 10.3030/777691

Closed project

EC signature date 21 September 2017

Start date 1 November 2017

End date 31 March 2022

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies – Biotechnology

Total cost € 3 571 137,50

EU contribution € 2 499 796,25

Coordinated by

FLOWSION AS
Denmark

Periodic Reporting for period 3 - GLUCOSTAT (Automatic Control of Blood Glucose Concentration for Intensive Care patients)

Reporting period: 2019-11-01 to 2022-03-31

Summary of the context and overall objectives of the project

The problem we addres is:
Effective control of blood glucose levels for critically ill patients in intensive care leads to significantly decreased mortality, morbidity and shorter length of stay and therefore has important impacts on patient wellbeing and healthcare costs. The current state of the art for blood glucose control is by discrete blood sampling which is insufficient at controlling rapidly changing levels of blood glucose concentration. This can put patients at risk of developing life threatening hypoglycaemic (low blood glucose) or hyperglycaemic (high blood glucose) episodes.
The GLUCOSTAT project will develop a first to the market integrated device that will enable automated control of blood glucose levels for patients in hospital Intensive Care Units (ICUs). This will improve the clinical outcomes for the patient as their blood glucose concentration will be maintained in the healthy normal concentration range (4-6 mM). Automatic blood glucose control will also decrease the workload on nurses as they no longer need to take frequent blood samples which will allow this valuable resource to be re-directed to more valuable roles within the intensive care wards. A move away from discrete sampling to an automated control system that maintains low fluctuations will result in a cost reduction of €2,638 per ICU patient and hence be more resource and labour efficient2.
Importance to society:
EU-wide challenges that are addressed by the GLUCOSTAT project – With an ageing population, an increase in the occurrence of type 2 diabetes in general and for older people in particular, an increase in the number of ICU patients that will suffer from high and strongly fluctuating blood glucose concentration is to be expected. Thus there is a clear need for improved blood glucose control in the ICU´s in EU. Just one example: ICU patients with sepsis cost on the average € 2.600 per day. We have conservatively estimated that length of stay can be lowered by one day @ € 2.600 per ICU patient with sepsis. Multiplied by the total annual number of ICU patients with sepsis (1.25 million) in the EU we arrive at potential savings of €3.3 billion annually through reduced length of stay in ICU’s due to reduced morbidity
Overall objectives of the GLUCOSTAT project is to optimise the existing system and processes used for its manufacture, and integrate an advanced adaptive, and predictive control algorithm to enable FLOWSION to apply for CE certification. The performance of the optimised CE marked Glycostat system will be evaluated via a clinical study where we will automate control the blood glucose level of ICU patients to stay within the normal 4-6 mM range. This will demonstrate the automated blood glucose control system’s effectiveness in terms of delivering good accuracy, usability and robustness, which will enable Flowsion to carry out post project commercialisation and market activities. Once the automated control system has been launched, penetrated the market, and proved itself in ICU patients with sepsis, a market potential of €4.5 billion can be achieved for FLOWSION by implementing the device across all ICU patients in the EU and USA. High growth of an estimated 387 total jobs will be realised by carrying out GLUCOSTAT since no instruments performing automated control of blood glucose are currently available for intensive care use, and as GLUCOSTAT will clearly demonstrate the advantages over existing procedures.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

WP 1 and WP4 Base unit update. The existing Base Unit HW, SW, and User Interface were updated. The updated HW and SW designs were approved in design reviews and functional tests, The finalized Base Unit will be handed over to Flowsion during early January 2019. After verification testing the Base Unit will be sent to EMC testing and electrical safety testing according to EN60601-1 and usability testing according to EN 62366.
WP 2 Front End Sensor update. The existing Front End Sensor (Optical Sensor) was retested and reviewed. The documentation was updated. Some updating was performed regarding cables and software interface to the Base Unit. Also the dynamic range was characterized, and a test- and calibration procedure was developed. With these updates the Front End Sensor can be used in the CE marked system
WP 3 Consumable update. The consumable was updated, including updating the probe, the existing moulds, and developing an insertion mechanism making placement of the Glycostat probe into the central venous catheter very easy for the doctor. All parts of the updated consumable were available during December 2018.
WP 5 Tests. Testing that Glycostat conforms to basic safety according to EN60601-1 and usability according to EN 62366 are key activitisy of the last 12 months of the GLUCOSTAT project.
WP 6 Manufacturing. The existing rented clean room facility was not available to Flowsion anymore. Thus, we decided to use the budget for the rented the clean room for building a temporary clean room for this project. The temporary clean room was finalized, and the first successful bioburden analysis was available in October 2018. The key manufacturing process that needed upgrade was gluing the reagent cassette. The glue connections on the previous design of the reagent cassette were degraded by sterilization and had too often to be re-glued. This problem was solved by replacing the glue connections by luer lock connections, thus getting rid of these gluing processes all together.
WP 7 Regulatory. The objective of WP 7 is to achieve CE certification for our quality management system and the Glycostat system. This work are key activities during the last 12 months of the GLUCOSTAT project
WP 8 Clinical study. This work package comprises preparation of documentation for ethics committee approval of the clinical study, and completing the clinical study showing that Glycostat is able to semi automatically to control the blood glucose level of ICU patients in the normal range, 4-6 mM. This work are key activities during the last 12 months of the GLUCOSTAT project
WP 9 Dissemination. We have updated our www.flowsion.dk website, identical to www.glycostat.com including the GLUCOSTAT project. We have sent out a press release via Businesswire regarding the EU grant for the GLUCOSTAT project. We have been very active participating in investor dating conferences in EU and USA organized by the EU and others in trying to attract investors to help funding in the marketing stage and the approval stage for the USA. Furthermore we have been in dialogue with FDA to verify the regulatory pathway in the USA and to verify that our strategy is still aligned with their policies. We have also been in dialogue with the NIH to explore the possibilities to attract support from them for the clinical studies needed for FDA approval.
WP 10 Project management. Project management has been and will be a key effort in securing the success of the GLUCOSTAT project. Frequent meetings of the Flowsion Management team, employees, third parties, and suppliers have been and will be key focus areas and activities in the GLUCOSTAT project.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Glycostat will be the first continuous central venous blood glucose sensor with an algorithm that gives advice to the ICU nurse pretty much like a GPS in a car advices the driver.
We have identified two patentable novelties during the first period of the GLUCOSTAT project that will results in two new patent applications.

Glycostat Base Unit in Measurements mode