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

Study Overview
=================
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.

Official 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

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Device: Space TGC


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control | Device: Space TGC<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (arterial) blood glucose values -> percentage of time within predefined glucose target range 80-150 mg/dL (4.4-8.3 mM) |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemia ≤ 40 md/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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU