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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Intravenous infusion delivery of Actrapid insulin and dextrose, dose calculated by Model Predictive Control (MPC) algorithm, based on continuous glucose sensor readings.
Standard intravenous insulin infusion sliding scale as per intensive care unit protocol.
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
Cambridge, Cambridgeshire, United Kingdom
Percentage of glucose values in target range (6.0 - 8.0 mmol/l) as recorded by reference glucose measurements.
Definition of Reference glucose = Blood Glucose level measured by arterial blood gas analyzer. During the study subjects will have the reference glucose measured every 1 hour and this is used for the calculation percentage glucose values.
Time frame: Up to 49 hours in each subject.
Percentage of glucose values in range (4.0 - 10.0 mmol/l) as recorded by reference glucose measurements.
Definition of Reference glucose = Blood Glucose level measured by arterial blood gas analyzer. During the study subjects will have the reference glucose measured every 1 hour and this is used for the calculation percentage glucose values.
Time frame: Up to 49 hours in each subject
Percentage of glucose values <4.0 mmol/l and >8.0 mmol/l as recorded by reference glucose measurements.
Definition of Reference glucose = Blood Glucose level measured by arterial blood gas analyzer. During the study subjects will have the reference glucose measured every 1 hour and this is used for the calculation percentage glucose values.
Time frame: Up to 49 hours in each subject.
Percentage of glucose values > 10.0 mmol/l as recorded by reference glucose measurements.
Definition of Reference glucose = Blood Glucose level measured by arterial blood gas analyzer. During the study subjects will have the reference glucose measured every 1 hour and this is used for the calculation percentage glucose values.
Time frame: Up to 49 hours in each subject,
Mean and standard deviation of reference glucose measured using arterial blood gas analyzer
Definition of Reference glucose = Blood Glucose level measured by arterial blood gas analyzer. This is reported in mmol/L During the study subjects will have the reference glucose measured every 1 hour and this is used for the calculation of mean (mmol/L) and standard deviation which will reflect the efficasy of closed loop insulin delivery.
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Time frame: Up to 49 hours in each subject.
Mean and median absolute and relative difference between matched pairs of subcutaneous glucose sensor and reference plasma glucose.
For a given subcutaneous glucose sensor value, difference between the sensor and the reference glucose will be calculated. Example - Reference glucose 10 mmol/L and sensor glucose 12 mmol/L, therefore absolute difference will be 2 mmol/L. Mean and median of these deviations will be reported in mmol/L. The term relative implies that data has been converted to a percentage deviation from reference glucose.
Time frame: Up to 49 hours in each subject.
Time to reach target glucose
Time frame: Up to 49 hours in each subject.
Insulin infusion rates
Time frame: Up to 49 hours in each subject.
Frequency and magnitude of significant hypoglycaemic (< 3.0 mmol/L), severe hypoglycaemic (<2.0 mmol/L) and significant hyperglycaemic (> 15mmol/l) episodes.
Time frame: Up to 49 hours in each subject.