Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
| Tracking Information | |||||
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| First Received Date ICMJE | January 26, 2012 | ||||
| Last Updated Date | January 30, 2012 | ||||
| Start Date ICMJE | October 2011 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01523665 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System | ||||
| Official Title ICMJE | Evaluation of Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | adult patients |
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| Condition ICMJE | Intensive Care Patients | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | October 2012 | ||||
| Estimated Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Czech Republic, Italy, Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01523665 | ||||
| Other Study ID Numbers ICMJE | HC-O-H-1102 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | B. Braun Melsungen AG | ||||
| Study Sponsor ICMJE | B. Braun Melsungen AG | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | B. Braun Melsungen AG | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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