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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01164423

Acronym

DELIOS 01

Enrollment

Registered

2010-07-16

Start date

2010-07-31

Completion date

2010-12-31

Last updated

2011-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU

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.

Interventions

DEVICESpace TGC

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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	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

Secondary

Measure	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	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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026