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

This study is currently recruiting participants.
Verified January 2012 by B. Braun Melsungen AG
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01523665
First received: January 26, 2012
Last updated: January 30, 2012
Last verified: January 2012

January 26, 2012
January 30, 2012
October 2011
October 2012   (final data collection date for primary outcome measure)
Blood glucose values: Percentage of time within the chosen glucose target range of 4.4 - 6.1 mmol/l or 4.4 - 8.3 mmol/l [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01523665 on ClinicalTrials.gov Archive Site
  • Frequency of hypoglycaemic episodes [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: Yes ]
  • Adherence to the advice of the SGC system [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: No ]
  • Blood glucose measurement interval [ Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days. ] [ Designated as safety issue: No ]
Same as current
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Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

adult patients

Intensive Care Patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion:

  • Intensive care patients who require blood glucose control by intravenous application of insulin

Exclusion:

  • All contraindication of intravenous insulin therapy
Both
Not Provided
No
Contact: Study Manager +49(0)5661710 studies@bbraun.com
Czech Republic,   Italy,   Sweden
 
NCT01523665
HC-O-H-1102
No
B. Braun Melsungen AG
B. Braun Melsungen AG
Not Provided
Not Provided
B. Braun Melsungen AG
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP