Feasibility of Blood Glucose Control With the Space TGC System in Medical ICU Patients (DELIOS 01)

This study has been completed.
Sponsor:
Information provided by:
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01164423
First received: July 15, 2010
Last updated: February 8, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Critical Illness
Device: Space TGC

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monocentric, Open Study to Investigate the Feasibility of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) in Medical ICU Patients

Resource links provided by NLM:


Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • (arterial) blood glucose values -> percentage of time within predefined glucose target range 80-150 mg/dL [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycaemia ≤ 40 mg/dl (2.2mM) [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
  • Concomitant medication including insulin infusion rate, parenteral/enteral nutrition [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Usability parameters like convenience of alarming function; workload; blood sampling frequency [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Space TGC system with incorporated eMPC advised insulin infusion to establish glycaemic control
Device: Space TGC
Space TGC with incorporated eMPC algorithm to establish glycaemic control with a blood glucose target range of 80-150 mg/dL (4.4-8.3 mM)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • age: > 18 years of age
  • stay in the ICU expected to be > 72 h
  • blood glucose > 110 mg/dl or patient on insulin treatment

Exclusion:

  • patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
  • known or suspected allergy to insulin
  • any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
  • moribund patients likely to die within 24 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164423

Locations
Austria
Medizinische Universität Graz, Department of Internal Medicine
Graz, Austria, 8036
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
Principal Investigator: Thomas R. Pieber, Prof. Landeskrankenhaus Universitätsklinikum Graz
  More Information

Publications:
Responsible Party: Dr. Norman Kachel, B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01164423     History of Changes
Other Study ID Numbers: HC-G-H-0905
Study First Received: July 15, 2010
Last Updated: February 8, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by B. Braun Melsungen AG:
algorithm
tight glycemic control
glucose control
intensive care
insulin
ICU

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014