Usability of Blood Glucose Control With the Space TGC System in Medical ICU Patients (DELIOS 4)
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Details and patient eligibility
About
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.
Enrollment
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Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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