Usability of Blood Glucose Control With the Space TGC System in Medical ICU Patients
- Conditions
- Critical Illness
- Interventions
- Device: Space TGC
- Registration Number
- NCT01164449
- Lead Sponsor
- B. Braun Melsungen AG
- Brief Summary
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control in medical ICU patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Space TGC Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control
- Primary Outcome Measures
Name Time Method (arterial) blood glucose values -> percentage of time within predefined glucose target range 80-150 mg/dL (4.4-8.3 mM) all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 14d
- Secondary Outcome Measures
Name Time Method Hypoglycaemia ≤ 40 md/dL (2.2mM) all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 14d Usability parameters like convenience of alarming function; workload; blood sampling frequency all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 14d Concomitant medication including insulin infusion rate, parenteral/enteral nutrition all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 14d
Trial Locations
- Locations (1)
University Hospital Zürich
🇨🇭Zürich, Switzerland