- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164423
Feasibility of Blood Glucose Control With the Space TGC System in Medical ICU Patients (DELIOS 01)
February 8, 2011 updated by: B. Braun Melsungen AG
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
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8036
- Medizinische Universität Graz, Department of Internal Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Space TGC system with incorporated eMPC advised insulin infusion to establish glycaemic control
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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)
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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
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
|
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
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
|
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
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
|
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)
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
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas R. Pieber, Prof., Landeskrankenhaus Universitatsklinikum Graz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC-G-H-0905
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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