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

November 26, 2013 updated by: B. Braun Melsungen AG

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic
        • Investigational site
      • Plzen, Czech Republic
        • Investigational site
      • Prague, Czech Republic
        • Investigational sites
  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet Copenhagen
      • Vejle, Denmark
        • Vejle Sygehus
  • Estonia
      • Tartu, Estonia
        • Tartu University Hospital
  • Germany
      • Augsburg, Germany
        • Klinikum
      • Leipzig, Germany
        • Universitätsklinikum Leipzig
  • Italy
      • Legnano, Italy
        • Investigational site
      • Siena, Italy
        • Investigational site
  • Poland
      • Wroclaw, Poland
        • Wroclaw Medical University
  • Spain
      • Madrid, Spain
        • Hospital Sur,
  • Sweden
      • Jönköping, Sweden
        • Investigational site
      • Stockholm, Sweden
        • Investigational site
      • Södertälje, Sweden
        • Investigational site
  • United Kingdom
      • Bury St Edmonds, United Kingdom
        • West Suffolk Hospital
      • Truro, United Kingdom
        • Royal Cornwall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

Inclusion:

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

Exclusion:

  • All contraindication of intravenous insulin therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of hypoglycaemic episodes
Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
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.
From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Blood glucose measurement interval
Time Frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (Estimate)

February 1, 2012

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • HC-O-H-1102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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