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

Intensive Care Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523665
• Other study ID #: HC-O-H-1102
• Status: Completed
• Phase: N/A
• First received: January 26, 2012
• Last updated: November 26, 2013
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion:

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

Exclusion:

• All contraindication of intravenous insulin therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intensive Care Patients

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Countries where clinical trial is conducted

Czech Republic,  Denmark,  Estonia,  Germany,  Italy,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		From start of treatment to the last glucose measurement under treatment, typically up to 14 days.	No
Secondary	Frequency of hypoglycaemic episodes		From start of treatment to the last glucose measurement under treatment, typically up to 14 days.	Yes
Secondary	Adherence to the advice of the Space GlucoseControl system		From start of treatment to the last glucose measurement under treatment, typically up to 14 days.	No
Secondary	Blood glucose measurement interval		From start of treatment to the last glucose measurement under treatment, typically up to 14 days.	No