Clinical trial NCT01164423: Feasibility of Blood Glucose Control With the Space TGC System in Medical ICU Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: algorithm
tight glycemic control
glucose control
intensive care
insulin
ICU
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2010-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: (arterial) blood glucose values -> percentage of time within predefined glucose target range 80-150 mg/dL
timeFrame: 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 outcomes:
measure: Hypoglycaemia ≤ 40 mg/dl (2.2mM)
timeFrame: 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
measure: Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
timeFrame: 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
measure: Usability parameters like convenience of alarming function; workload; blood sampling frequency
timeFrame: 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
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz, Department of Internal Medicine
Study officials:
affiliation: Landeskrankenhaus Universitätsklinikum Graz
name: Thomas R. Pieber, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.