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Clinical Trials/NCT01523665
NCT01523665
Completed
Not Applicable

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

B. Braun Melsungen AG12 sites in 9 countries508 target enrollmentOctober 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Patients
Sponsor
B. Braun Melsungen AG
Enrollment
508
Locations
12
Primary Endpoint
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
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
July 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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.)

Study Sites (12)

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