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OpenTrials
Completed

NCT Number: NCT01523665

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

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

Exclusion:

  • All contraindication of intravenous insulin therapy

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Frequency of hypoglycaemic episodes

    Time frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

  2. 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.

  3. Blood glucose measurement interval

    Time frame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2012
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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