eHealth Project of the Month -
CLINICIP (ICU's Intelligent Glucose Monitoring)

Monday, 10 September 2007

Thousands of patients in European intensive care units (ICUs) develop high glucose levels that need to be treated with insulin. Many ICUs cannot easily control the glucose level and as a result, these patients have a much higher risk to die or to develop complications. Within the EC funded project CLINICIP, a system that will help ICU staff to implement glucose control has been developed. The system is presently being clinically approved and is expected to be soon released to the market. Patients in intensive care units (ICUs) can develop high glucose levels. Shock and trauma because of surgical procedures are the major causes for these atypical physiological symptoms which are comparable to those of diabetes mellitus.

A number of clinical studies indicated that normalisation of high glucose levels with insulin dramatically improves the survival chances in these ICU patients.

However, treatment of glycaemia with target glucose levels close to normal physiological range is labour-intensive and although the cause/effect is well-known, the unmanageable workload and the prevalent fear of low glucose levels still prevent the general implementation of glycaemic control in ICUs until now.

In a combined effort, clincians and scientists have joined forces in the CLINICIP project to develop an intelligent glucose monitoring and control system for critically ill patients. The overall goal of the CLINICIP system was to establish glycaemic control in order to improve survival chances in ICUs and increase efficiency and safety in clinical practice. The CLINICIP partners followed a 2-step approach: Within a first step, a decision support system has been developed that combines automated insulin delivery with an intelligent algorithm to analyse how much insulin is needed, based on carbohydrate intake and current glucose levels. Within a second step, sensor systems are developed in order to establish a complete glycaemic control system.

Results and expected impact
The 1st CLINICIP Prototype version has been successfully tested at Royal Brompton Hospital (UK) and Medical University of Graz (AT). These clinical studies have been performed as medical device approval studies towards product evaluation and certification.

Also regarding the full implementation of the closed-loop approach, first clinical studies have been started and are presently successfully in operation at Charles University Prague and Medical University Graz. The results of these studies will bring a proof of concept and will set a milestone in order to initiate further collaboration among the CLINICIP partners.  Recent studies on the 1st CLINICIP Prototype implementation have led to further improvement in terms of usability, acceptability and stability of the system.

The actually available CLINICIP Prototype system is seen as essential cornerstone of the project's outputs and will serve as an important component in the future workflow of the ICUs.

Market release of the above mentioned CLINICIP decision support system can be approximately scheduled with early 2009.

Related news articles:

• Automating insulin delivery for critically ill patients

Project website : http://www.clinicip.org