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Closed Loop INsulin Infusion for Critically Ill Patients

Descrizione del progetto

eHealth
Intelligent glucose monitoring

Devices to regulate the blood-sugar levels of critically ill patients in intensive care wards are set to improve treatment and even save lives when they go into commercial use in the coming years.

Developed by the CLINICIP project, the intelligent devices address a potentially fatal side effect of trauma and shock: rapid increases in the body’s glucose levels that intensive care unit (ICU) doctors and nurses have typically found hard to control.

As with diabetes, high glucose levels in trauma patients can be brought down through infusions of insulin. However, in an ICU environment the changes are often more rapid, and an excessive dose of insulin can lead to dangerously low blood sugar, a condition known as hypoglycaemia.

Controlling the risks of irregular blood sugar

The CLINICIP team saw where technology could come to the aid of ICU patients. Working in collaboration with several European hospitals, they developed and tested a device to support nurses in deciding how much insulin and how frequently to administer it, while also working towards a more advanced system that would automate insulin injections entirely.

The decision-support device, which is expected to be commercially available in 2009 after further trials, still relies on nurses drawing blood from patients and testing glucose levels in the traditional way.

However, instead of administering the insulin directly they input the glucose information into the device via a touch screen. A specially designed algorithm then calculates how much insulin is needed before administering it to the patient. The device alerts nurses when blood samples need to be taken, which can be as frequently as every half hour.

Using the system in trials, just one hypoglycaemic event was recorded in 434 ICU days.

Automatic insulin injections

The automated version of the system, which the project partners expect to make available commercially in 2011, goes one step further in order to minimise the need for nurses to intervene.

Using a glucose-monitoring interface and an insulin-infusion interface in a closed-loop system, the device draws blood samples from the patient automatically, calculates the insulin required to bring their blood sugar within normal levels, then administers the correct dose.

Improving patients’ chances of survival

Clinical trials in Europe have shown that such a device would probably dramatically improve the survival chances of critically ill patients who develop irregular glucose levels. Although hospitals frequently check blood sugar in ICU patients, few have implemented tight controls because of the risks of overcompensating and the need to have more nursing staff dedicated to glucose control.

CLINICIP’s automated system overcomes both those problems, while its decision-support device reduces the risks of nurses giving an incorrect insulin dose.

Healthy people can develop atypical physiological symptoms under critically ill conditions, e.g. in the intensive care unit (ICU). Due to shock and trauma as a consequence of the surgery, the glucose concentration is likely to rise significantly comparable to the symptoms known as insulin-dependent Diabetes Mellitus. Similar to diabetes mellitus, the high glucose level needs to be treated with external insulin. According to a study in Belgium the intensive insulin therapy treatment cuts the mortality rates by 42% compared to standard insulin therapy for ICU indication.The project provides an intelligent system for improved health status monitoring of critically ill patients. A local system will be developed comprising biosensors for the determination of glucose in whole blood. Based on the continuous measurement, an adaptive control algorithm generates advice and thus represents a decision supporting system in an early project stage. Within a closed loop system intensified insulin treatment will make use of calculation results leading to the external regulation of glucose. In addition to the approach of controlling the glucose concentration, a minimally invasive treatment will be investigated. A number of biosensors for the determination of most important parameters such as lactate, carbon dioxide, oxygen and pH will be used to characterize adipose tissue.In order to support the implementation of intensified treatment in an optimal way, a telemedical infrastructure will be developed. This includes a knowledge sharing environment, allowing the involved clinical centres to store and share their newly generated knowledge. Additionally all data resulting from clinical trials will be saved on the server. In later stages of the project, access to the data and the derived clinical recommendations for treatment of critically ill patient will be granted to additional clinical partners who are willing to implement improved treatment.

Invito a presentare proposte

FP6-2002-IST-1
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Meccanismo di finanziamento

IP - Integrated Project

Coordinatore

JOANNEUM RESEARCH FORSCHUNGSGESELLSCHAFT MBH
Contributo UE
€ 1 907 976,00
Indirizzo
LEONHARDSTRASSE 59
8010 Graz
Austria

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Regione
Südösterreich Steiermark Graz
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Partecipanti (12)