March 2007

CLINICIP Project Draws Great Interest in Europe

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Every year thousands of ICU patients develop atypical physiological symptoms, which keep them ill longer than necessary. Many even succumb to death due to these physiological maladies, which may result from the inability of many ICUs to control the level of glucose in patients' blood. As glucose affects blood toxicology, any mismana-gement of glucose level can be detrimental to the patient's health.

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 percent, as compared to standard insulin therapy for ICU indication.
Medical science has realized the importance of glucose control for ICU patients, but couldn't find an effective solution to the problem till now, largely due to the enormous complexity of the problem.  Recording glucose levels manually is not only painstaking and time consuming, but since the impact of glucose levels and insulin dose vary from patient to patient, it is very subjective.

One EU project, funded under the 6th FWP (Sixth Framework Programme) is endeavouring to find a solution to this problem. CLINICIP (Closed Loop Insulin Infusion for Critically Ill Patients) project aims to provide a pragmatic and innovative system for improved health status monitoring of critically ill patients.

The project endeavours to develop an intelligent, automated glucose monitoring and control system for ICU patients. Monitoring glucose levels and administering of insulin is done by one self-contained system, and therefore it is called a 'closed loop' system. Within a closed loop system, intensified insulin treatment will make use of calculation results, leading to the external regulation of glucose.

In addition to controlling the glucose concentration, a minimally invasive treatment would also be explored upon. 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.

The CLINICIP partners (various institutes and universities from Austria, Germany, Sweden, Italy, UK, Belgium, Switzerland and Czech Republic) are developing a system that links glucose measurement to a control unit, which would assess a patient's needs, and then release insulin automatically. The researchers have already developed an algorithm to analyze how much insulin is needed, based on carbohydrate intake and current glucose levels. Already CLINICIP's algorithm has garnered great interest among medical scientists. The algorithm is in trials, and the partners hope to have initial results by mid 2007.

Presently, the CLINICIP project is studying both intra-vascular and extra-vascular automated sensor systems. If the quest of the researchers becomes successful, automated sensor systems could improve the healthcare of ICU patients and pave the way for healthy clinical practice. Here it deserves a mention that the intra-vascular sensor system is more invasive and time consuming than extra-vascular sensor system, and moreover the former is not suited for cardiac attack victims and infants. In later stages of the project, access to the data and the derived clinical recommendations for treatment of critically ill patients will be granted to additional clinical partners who are willing to implement improved treatment.

The major impediment to the success of this much-hyped project is the body interface, that is tackling the question of how the sensor in the patient's body would link to the rest of the closed-loop system. However Martin Ellmerer, the Scientific Director of the CLINICIP project, is sceptical about the development of the full closed-loop system within the scheduled gestation timeframe of the project. However, work will continue even after the expiry of the life of this project. 

Existing bilateral agreements between many of the CLINICIP project partners can carry out the good work initiated by the project, even after the expiry period of the project. The 11.21 million euro project, which began in January 2004, has a duration of 48 months. The project is supposed to be completed by the end of 2007(31 Dec. 2007 to be precise).  

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