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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01523665
First received: January 26, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition
Intensive Care Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

Resource links provided by NLM:


Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 Space GlucoseControl 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 ]

Enrollment: 508
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult patients

Criteria

Inclusion:

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

Exclusion:

  • All contraindication of intravenous insulin therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523665

Locations
Czech Republic
Investigational Site
Hradec Kralove, Czech Republic
Investigational Site
Plzen, Czech Republic
Investigational sites
Prague, Czech Republic
Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark
Vejle Sygehus
Vejle, Denmark
Estonia
Tartu University Hospital
Tartu, Estonia
Germany
Klinikum
Augsburg, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Italy
Investigational Site
Legnano, Italy
Investigational site
Siena, Italy
Poland
Wroclaw Medical University
Wroclaw, Poland
Spain
Hospital Sur,
Madrid, Spain
Sweden
Investigational Site
Jönköping, Sweden
Investigational Site
Stockholm, Sweden
Investigational Site
Södertälje, Sweden
United Kingdom
West Suffolk Hospital
Bury St Edmonds, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Sponsors and Collaborators
B. Braun Melsungen AG
  More Information

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01523665     History of Changes
Other Study ID Numbers: HC-O-H-1102
Study First Received: January 26, 2012
Last Updated: November 26, 2013
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on July 24, 2014