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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- B. Braun Melsungen AG
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- (arterial) blood glucose values -> percentage of time within predefined glucose target range 80-150 mg/dL (4.4-8.3 mM)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
1
Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control
Intervention: Space TGC (Device)
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)(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)