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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01164449

Critical Illness

COMPLETED NA

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

NCT01146847

Critical Illness

COMPLETED NA

Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU

NCT01233271

Critical Illness

COMPLETED NA

Blood Glucose Control With A Software-Algorithm In Intensive Care Unit (ICU) Patients

NCT00735163

Critical Illness

COMPLETED NA

Blood Glucose Control in Intensive Care Patients Using the Space GlucoseControl System

NCT01523665

Intensive Care Patients

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Space TGC system with incorporated eMPC advised insulin infusion to establish glycaemic control

Group Type EXPERIMENTAL

Space TGC

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Space 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)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No