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

Completed

• Conditions: Intensive Care Patients

• Registration Number: NCT01523665
• Lead Sponsor: B. Braun Melsungen AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Blood glucose measurement interval	From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Frequency of hypoglycaemic episodes	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	From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

Trial Locations

Locations (12)

Investigational site; 🇮🇹 Siena, Italy

West Suffolk Hospital; 🇬🇧 Bury St Edmonds, United Kingdom

Royal Cornwall Hospital; 🇬🇧 Truro, United Kingdom

Wroclaw Medical University; 🇵🇱 Wroclaw, Poland

Investigational Site; 🇸🇪 Södertälje, Sweden

Hospital Sur,; 🇪🇸 Madrid, Spain

Investigational sites; 🇨🇿 Prague, Czech Republic

Tartu University Hospital; 🇪🇪 Tartu, Estonia

Klinikum; 🇩🇪 Augsburg, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany

Rigshospitalet Copenhagen; 🇩🇰 Copenhagen, Denmark

Vejle Sygehus; 🇩🇰 Vejle, Denmark