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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Space TGC system with incorporated eMPC advised insulin infusion to establish glycaemic control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Space TGC | Device | 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) |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Concomitant medication including insulin infusion rate, parenteral/enteral nutrition |
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Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R. Pieber, Prof. | Landeskrankenhaus Universitätsklinikum Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz, Department of Internal Medicine | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20388051 | Background | 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. | |
| 19885285 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
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| 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 |
| 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 |
| 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. |
| 18297268 | Background | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |