Closed Loop Glucose Control in Intensive Care Unit

NCT ID: NCT01440842

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-10-31

Brief Summary

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.

Detailed Description

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.

Conditions

Stress Hyperglycaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed-loop (Model Predictive Control Algorithm)

Group Type: EXPERIMENTAL

Closed-loop insulin delivery

Intervention Type: OTHER

Intravenous infusion delivery of Actrapid insulin and dextrose, dose calculated by Model Predictive Control (MPC) algorithm, based on continuous glucose sensor readings.

Open loop (Standard treatment)

Group Type: ACTIVE_COMPARATOR

Standard IV insulin infusion sliding scale

Intervention Type: OTHER

Standard intravenous insulin infusion sliding scale as per intensive care unit protocol.

Interventions

Closed-loop insulin delivery

Intravenous infusion delivery of Actrapid insulin and dextrose, dose calculated by Model Predictive Control (MPC) algorithm, based on continuous glucose sensor readings.

Intervention Type: OTHER

Standard IV insulin infusion sliding scale

Standard intravenous insulin infusion sliding scale as per intensive care unit protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Aged 18 years and older

Exclusion Criteria

• Stay in intensive care unit expected to be at least 48 hours
• At least one of the following conditions applies:
• Not on insulin infusion and single confirmed reference blood glucose level > 10.0 mmol/l
• Already on insulin infusion including those subjects with pre-existing diabetes.

• Patients with diabetic ketoacidosis or hyperosmolar hyperglycaemic non-ketotic coma (HONK)
• Patients who are receiving therapeutic hypothermia
• 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)
• Patients with significant abnormalities of blood clotting.
• Moribund patients likely to die within 48 hours
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: lead

Responsible Party

Lalantha Leelarathna

Clinical Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roman Hovorka, BSc MSc PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Rowan Burnstein, MBBS FRCA PhD

Role: PRINCIPAL_INVESTIGATOR

Addenbrooke's Hospital, Cambridge, United Kingdom

Locations

Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23883613 (View on PubMed)

Other Identifiers

CLASSIC 01

Identifier Type: -

Identifier Source: org_study_id