NCT01523665

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
508

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
8 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

1.8 years

First QC Date

January 26, 2012

Last Update Submit

November 26, 2013

Conditions

Intensive Care Patients

Outcome Measures

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

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

Secondary Outcomes (3)

  • 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.

  • Blood glucose measurement interval

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

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

You may not qualify if:

  • All contraindication of intravenous insulin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Investigational Site

Hradec Králové, Czechia

Location

Investigational Site

Pilsen, Czechia

Location

Investigational sites

Prague, Czechia

Location

Rigshospitalet Copenhagen

Copenhagen, Denmark

Location

Vejle Sygehus

Vejle, Denmark

Location

Tartu University Hospital

Tartu, Estonia

Location

Klinikum

Augsburg, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Investigational Site

Legnano, Italy

Location

Investigational site

Siena, Italy

Location

Wroclaw Medical University

Wroclaw, Poland

Location

Hospital Sur,

Madrid, Spain

Location

Investigational Site

Jönköping, Sweden

Location

Investigational Site

Södertälje, Sweden

Location

Investigational Site

Stockholm, Sweden

Location

West Suffolk Hospital

Bury Saint Edmonds, United Kingdom

Location

Royal Cornwall Hospital

Truro, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 26801983DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

February 1, 2012

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

ES(1)DE(2)SE(3)GB(2)DK(2)CZ(3)IT(2)PL(1)