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

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Device: Space TGC

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medizinische Universität Graz, Department of Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Thomas R. Pieber, Prof., Landeskrankenhaus Universitatsklinikum Graz

Publications and helpful links

General Publications

• Amrein K, Ellmerer M, Hovorka R, Kachel N, Parcz D, Korsatko S, Smolle K, Perl S, Bock G, Doll W, Kohler 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. doi: 10.1089/dia.2009.0147.
• Kulnik R, Plank J, Pachler C, Wilinska ME, Groselj-Strele A, Rothlein 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. doi: 10.1177/193229680800200606.
• 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. doi: 10.1007/s00134-008-1033-8. Epub 2008 Feb 23.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: July 15, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (ESTIMATE): July 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2011
• Last Update Submitted That Met QC Criteria: February 8, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: ICU; algorithm; tight glycemic control; glucose control; intensive care; insulin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HC-G-H-0905