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

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ClinicalTrials.gov Identifier: NCT01164423
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : February 9, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Critical Illness Device: Space TGC

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. (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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: February 2011

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