Usability of Blood Glucose Control With the Space TGC System in Medical ICU Patients

B. Braun Melsungen AG20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Critical Illness

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

(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

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

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

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

Usability of Blood Glucose Control With the Space TGC System in Medical ICU Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes