Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Criteria
Inclusion:
- Intensive care patients who require blood glucose control by intravenous application of insulin
Exclusion:
- All contraindication of intravenous insulin therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational Site | Hradec Kralove | Czech Republic | ||
| 2 | Investigational Site | Plzen | Czech Republic | ||
| 3 | Investigational sites | Prague | Czech Republic | ||
| 4 | Rigshospitalet Copenhagen | Copenhagen | Denmark | ||
| 5 | Vejle Sygehus | Vejle | Denmark | ||
| 6 | Tartu University Hospital | Tartu | Estonia | ||
| 7 | Klinikum | Augsburg | Germany | ||
| 8 | Universitätsklinikum Leipzig | Leipzig | Germany | ||
| 9 | Investigational Site | Legnano | Italy | ||
| 10 | Investigational site | Siena | Italy | ||
| 11 | Wroclaw Medical University | Wroclaw | Poland | ||
| 12 | Hospital Sur, | Madrid | Spain | ||
| 13 | Investigational Site | Jönköping | Sweden | ||
| 14 | Investigational Site | Stockholm | Sweden | ||
| 15 | Investigational Site | Södertälje | Sweden | ||
| 16 | West Suffolk Hospital | Bury St Edmonds | United Kingdom | ||
| 17 | Royal Cornwall Hospital | Truro | United Kingdom |
Sponsors and Collaborators
- B. Braun Melsungen AG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HC-O-H-1102