CLASSIC
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
Sponsor study identifier
interventional
24
1 country
1
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 22, 2011
Actual (reported)September 27, 2011
Actual (reported)May 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 2012
Actual (reported)October 2012
Actual (reported)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.
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.
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.
Up to 49 hours in each subject.
Percentage of glucose values > 10.0 mmol/l as recorded by reference glucose measurements.
Up to 49 hours in each subject,
Mean and standard deviation of reference glucose measured using arterial blood gas analyzer
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.
Up to 49 hours in each subject.
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, CB2 0QQ, United Kingdom
Leelarathna L, English SW, Thabit H, Caldwell K, Allen JM, Kumareswaran K, Wilinska ME, Nodale M, Mangat J, Evans ML, Burnstein R, Hovorka R. Feasibility of fully automated closed-loop glucose control using continuous subcutaneous glucose measurements in critical illness: a randomized controlled trial. Crit Care. 2013 Jul 24;17(4):R159. doi: 10.1186/cc12838.
Roman Hovorka, BSc MSc PhD
University of Cambridge
Rowan Burnstein, MBBS FRCA PhD
Addenbrooke's Hospital, Cambridge, United Kingdom
24 participants (actual enrollment reported by the registry).
First Submitted
September 22, 2011
First Posted
September 27, 2011
Study Start
May 2012
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 2012
Actual (reported)Study Completion
October 2012
Actual (reported)Last Updated
January 3, 2013
Record last verified: 2012-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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