Stress Hyperglycaemia Clinical Trial
Official title:
An Open-label, Single-centre, Randomised Controlled Trial to Assess the Safety and Efficacy of Automated Closed-loop Blood Glucose Control in Comparison With Standard Care in Adults in Intensive Care Unit
The purpose of this study is to assess the efficacy, safety and feasibility of a computer-based control algorithm to control glucose levels in adults in intensive care unit, in comparison to standard care.
This will be a single centre, open-label, randomised, parallel design, feasibility study
conducted at Neurosciences Critical Care Unit (NCCU), Addenbrooke's hospital, Cambridge, UK.
Study will aim for 24 adult subjects (12 participants in each arm of the trial) and study
will last for up to 49 hours in each subject. Subjects will have a commercially available
Conformité Européenne(CE) marked subcutaneous glucose sensor inserted at the start of the
study. Glucose data from the sensor will be transmitted to a small bedside tablet computer,
containing the algorithm which will determine insulin infusion rates aimed at maintaining
glucose level between 6.0 - 8.0 mmol/L. The advice from the algorithm will be sent to the
infusion pump via USB cable and insulin will be delivered intravenously. The system will
also deliver intravenous glucose via a second infusion pump at times of low glucose levels.
Samples for reference glucose values will be obtained either from an arterial line or
central venous cannula and will be analysed using standard blood gas analyser in real time.
Subjects randomised to standard care will receive intravenous insulin based on current
treatment guidelines at the Neurosciences critical care unit (NCCU), Addenbrooke's Hospital,
Cambridge, UK.
The primary outcome is time spent in target glucose range between 6.0 to 8.0 mmol/L as
recorded by reference glucose. Secondary outcomes are the time spent with glucose levels
above and below target, as recorded by reference glucose, and sensor accuracy. Safety
includes evaluation of significant hypoglycaemia and hyperglycaemia and other adverse
events.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment