Feasibility of Blood Glucose Control With the Space TGC System in Medical ICU Patients - Full Text View

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:

MedlinePlus related topics: Blood Sugar Diabetes Medicines

Drug Information available for: Dextrose

U.S. FDA Resources

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

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:

Amrein K, Ellmerer M, Hovorka R, Kachel N, Parcz D, Korsatko S, Smolle K, Perl S, Bock G, Doll W, Köhler G, Pieber TR, Plank J. Hospital glucose control: safe and reliable glycemic control using enhanced model predictive control algorithm in medical intensive care unit patients. Diabetes Technol Ther. 2010 May;12(5):405-12.

Kulnik R, Plank J, Pachler C, Wilinska ME, Groselj-Strele A, Röthlein D, Wufka M, Kachel N, Smolle KH, Perl S, Pieber TR, Hovorka R, Ellmerer M. Evaluation of implementation of a fully automated algorithm (enhanced model predictive control) in an interacting infusion pump system for establishment of tight glycemic control in medical intensive care unit patients. J Diabetes Sci Technol. 2008 Nov;2(6):963-70.

Pachler C, Plank J, Weinhandl H, Chassin LJ, Wilinska ME, Kulnik R, Kaufmann P, Smolle KH, Pilger E, Pieber TR, Ellmerer M, Hovorka R. Tight glycaemic control by an automated algorithm with time-variant sampling in medical ICU patients. Intensive Care Med. 2008 Jul;34(7):1224-30. Epub 2008 Feb 23.

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 May 19, 2013

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