NCT01523665

Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 508 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Glucose metabolism is impaired in many critically ill patients and is often aggravated by parenteral feeding, infections and/or pre-existent diabetes.Therefore insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented on most critical care units. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Several barriers to the implementation of glycemic control have been identified. Most importantly, there is concern about increased frequency of severe hypoglycemic episodes. To overcome these problems Space GlucoseControl was developed as a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges (4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l). The objective of this non-interventional study is to gain additional information on the performance of the Space GlucoseControl system for glycaemic control in ICU patients when used in routine clinical practice.

Conditions

• Intensive Care Patients

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-02-01
• Last updated: 2013-11-27

Locations

17 sites across 9 countries: Czechia, Denmark, Estonia, Germany, Italy, Poland, Spain, Sweden, United Kingdom