Feasibility of Blood Glucose Control With the Space TGC System in Medical ICU Patients

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: Space TGC

• Registration Number: NCT01164423
• 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

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-08
• Last Update Posted: 2011-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

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 infusion 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	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 mg/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
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
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

Trial Locations

Locations (1)

Medizinische Universität Graz, Department of Internal Medicine; 🇦🇹 Graz, Austria