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NCT Number: NCT01164449

Usability of Blood Glucose Control With the Space TGC System 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.

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Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zürich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Age: > 18 years of age
  • Stay in the ICU expected to be > 72 h
  • Blood glucose > 6.1 mmol/L 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

Treatment and study plan

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)

Primary outcomes

  1. (arterial) blood glucose values -> percentage of time within predefined glucose target range 80-150 mg/dL (4.4-8.3 mM)

    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

Secondary outcomes

  1. Hypoglycaemia ≤ 40 md/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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

Monocentric, Open Study to Investigate the Usability of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) Over a Glucose Control Range of 4.4 to 8.3 mmol/L in Medical ICU Patients

Acronym: DELIOS 4

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 16, 2010
Registry last updated
Aug 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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