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