Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2) (LOGIC-2)

January 7, 2016 updated by: Greet Van den Berghe, KU Leuven

LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-2 Multicentre Randomized Controlled Trial

Most critically ill patients are confronted with hyperglycaemia, which is associated with an increased mortality and morbidity risk. Normalising these elevated blood glucose levels by intensive insulin therapy may improve patient outcome, but is associated with an increased risk of hypoglycaemia. The LOGIC-2 study hypothesises that the LOGIC-Insulin computerised software algorithm will allow better (less hyperglycaemia) and safer (less hypoglycaemia) blood glucose control in critically ill patients than nurse-directed blood glucose control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1550

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Jessa Hospital
      • Leuven, Belgium, 3000
        • Dept Intensive Care Medicine, University Hospitals Leuven
      • Leuven, Belgium, 3000
        • Medical Intensive Care, University Hospitals Leuven
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Academic Medical Center (AMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to the ICU with an expected stay of at least 48 hours and already receiving or potentially needing insulin infusion for blood glucose control. These patients should already have or need an arterial and central venous line
  • Patients should be 18 years or older

Exclusion Criteria:

  • Not critically ill
  • Age under 18 years
  • Patients already enrolled in another intervention randomized controlled trial
  • Patients expected to die within 12 hours (=moribund patients)
  • No arterial line or central venous line needed
  • Pregnancy or lactating
  • Patients suffering from ketoacidotic or hyperosmolar coma on admission
  • Patients who have been previously been included in the LOGIC-2 study
  • Allergy to insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nurse-directed
Blood glucose control guided by paper protocol
Device: Paper protocol
Experimental: LOGIC-Insulin
Blood glucose control guided by the LOGIC-Insulin algorithm
Device: LOGIC-Insulin algorithm

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic Penalty Index (GPI) during the Intervention
Time Frame: up to 14 days post-randomization
Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control)
up to 14 days post-randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention
Time Frame: up to 14 days post-randomization
Proportion of patients to have had one or more episodes of severe hypoglycaemia (<40 mg/dL) during the intervention
up to 14 days post-randomization
Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention
Time Frame: up to 14 days post-randomization
Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention
up to 14 days post-randomization
Blood Glucose Level Per Treatment Group during the Intervention
Time Frame: up to 14 days post-randomization
Mean and median arterial blood glucose level
up to 14 days post-randomization
Hyperglycaemic index (HGI)
Time Frame: up to 14 days post-randomization
Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI)
up to 14 days post-randomization
Time in target range
Time Frame: up to 14 days post-randomization
up to 14 days post-randomization
Time to target range
Time Frame: up to 14 days post-randomization
up to 14 days post-randomization
Daily maximal blood glucose difference
Time Frame: up to 14 days post-randomization
marker of blood glucose fluctuations
up to 14 days post-randomization
Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention
Time Frame: up to 14 days post-randomization
Number of mild hypoglycaemic values as a fraction of all blood glucose measurements during the intervention
up to 14 days post-randomization
Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention
Time Frame: up to 14 days post-randomization
Proportion of patients to have had one or more episodes of mild hypoglycaemia during the intervention
up to 14 days post-randomization
Interval between blood glucose measurements
Time Frame: up to 14 days post-randomization
marker of workload
up to 14 days post-randomization
Protocol compliance in the intervention group
Time Frame: up to 14 days post-randomization
the number and proportion of patients in which the LOGIC-Insulin was not followed for a time period of at least 8 hours, which is the duration of one nurse shift.
up to 14 days post-randomization
Overrules in the intervention group
Time Frame: up to 14 days post-randomization

the number and proportions of recommendations by the software that were overruled by the bed-side nurses

  • Minor overrules: absolute insulin dose difference of >0.1 and < 1IU/h
  • Major overrules: absolute insulin dose difference of >= 1IU/h
  • Major overrules will also be qualitatively assessed
up to 14 days post-randomization
Incidence of new infections in the ICU
Time Frame: up to 90 days post-randomization
The diagnosis of "new infection" will be based on the administration of antibiotics, beyond the prophylactic scope
up to 90 days post-randomization
Length of stay in the ICU
Time Frame: up to 90 days post-randomization
up to 90 days post-randomization
Length of stay in the hospital
Time Frame: up to 90 days post-randomization
up to 90 days post-randomization
Mortality in the ICU
Time Frame: up to 90 days post-randomization
up to 90 days post-randomization
Mortality in the hospital
Time Frame: up to 90 days post-randomization
up to 90 days post-randomization
Landmark 90-day mortality
Time Frame: up to 90 days post-randomization
up to 90 days post-randomization
All direct medical costs from a healthcare payer's perspective
Time Frame: up to 90 days post-randomization
up to 90 days post-randomization
Quality of Life
Time Frame: up to 90 days post-randomization
EuroQol-5D
up to 90 days post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KU Leuven

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Agentschap voor Innovatie door Wetenschap en Technologie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dieter Mesotten, MD, PhD, KU Leuven
  • Principal Investigator: Greet Van den Berghe, MD, PhD, KU Leuven
  • Principal Investigator: Jasperina Dubois, MD, Jessa hospital, Hasselt
  • Principal Investigator: Marcus Schultz, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LOGIC-Insulin 2.1.1
  • ML9517 (Other Identifier: IRB-BE)
  • S55613 (Other Identifier: University Hospitals Leuven)
  • 80M0563 (Other Identifier: FAMHP)
  • IWT-TBM 100793 (Other Grant/Funding Number: IWT-TBM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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