Clinical trial NCT01523665: Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
Official title: Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Patients
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 508
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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.


Eligibility criteria: Inclusion:

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

Exclusion:

* All contraindication of intravenous insulin therapy

Primary outcomes:
measure: 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
timeFrame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Secondary outcomes:
measure: Frequency of hypoglycaemic episodes
timeFrame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
measure: Adherence to the advice of the Space GlucoseControl system
timeFrame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
measure: Blood glucose measurement interval
timeFrame: From start of treatment to the last glucose measurement under treatment, typically up to 14 days.
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
facility: Investigational Site
city: Plzen
country: Czech Republic
facility: Investigational Site
city: Prague
country: Czech Republic
facility: Investigational sites
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Augsburg
country: Germany
facility: Klinikum
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Legnano
country: Italy
facility: Investigational Site
city: Siena
country: Italy
facility: Investigational site
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
city: Madrid
country: Spain
facility: Hospital Sur,
city: Jönköping
country: Sweden
facility: Investigational Site
city: Stockholm
country: Sweden
facility: Investigational Site
city: Södertälje
country: Sweden
facility: Investigational Site
city: Bury St Edmonds
country: United Kingdom
facility: West Suffolk Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
References:
citation: Blaha J, Barteczko-Grajek B, Berezowicz P, Charvat J, Chvojka J, Grau T, Holmgren J, Jaschinski U, Kopecky P, Manak J, Moehl M, Paddle J, Pasculli M, Petersson J, Petros S, Radrizzani D, Singh V, Starkopf J. Space GlucoseControl system for blood glucose control in intensive care patients--a European multicentre observational study. BMC Anesthesiol. 2016 Jan 22;16:8. doi: 10.1186/s12871-016-0175-4.