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Critical IllnessLOGIC-2NCT02056353

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

A study testing LOGIC-Insulin algorithm and Paper protocol in people with Critical Illness and Hyperglycemia, run by KU Leuven at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness, Hyperglycemia, Hypoglycemia
What is being tested?
LOGIC-Insulin algorithm and Paper protocol
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,550 participants
Where
4 sitesin 2 countries
Study dates
Feb 2014to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Patients suffering from ketoacidotic or hyperosmolar coma on admission
  • Patients who have been previously been included in the LOGIC-2 study
  • Allergy to insulin

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Belgium3 sites

  • Jessa Hospital

    Hasselt, 3500

  • Dept Intensive Care Medicine, University Hospitals Leuven

    Leuven, 3000

  • Medical Intensive Care, University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

Netherlands1 site

  • Academic Medical Center (AMC)

    Amsterdam, 1105

Other trials in Netherlands

About this study

Official title: 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.

Being tested
LOGIC-Insulin algorithm, Paper protocol
Keywords
Software, Algorithm, Cardiac surgery
Medical subject headings
Critical Illness, Hyperglycemia, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LOGIC-Insulin algorithmDevice

  • Paper protocolDevice

Study groups in NCT02056353
Study groupRoleWhat they receive
Nurse-directedActive comparatorBlood glucose control guided by paper protocol
Receives: Device: Paper protocol
LOGIC-InsulinExperimentalBlood glucose control guided by the LOGIC-Insulin algorithm
Receives: Device: LOGIC-Insulin algorithm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycemic Penalty Index (GPI) during the Intervention

    Adequacy of reaching and maintaining the target range for blood glucose during the intervention (Effectiveness of glycaemic control)

    Measured: up to 14 days post-randomization

Secondary outcomes (20)

  1. Proportion of Patients With Severe Hypoglycaemia (<40 mg/dL) during the Intervention

    Proportion of patients to have had one or more episodes of severe hypoglycaemia (<40 mg/dL) during the intervention

    Measured: up to 14 days post-randomization

  2. Incidence of Severe Hypoglycemia (<40 mg/dL) during the Intervention

    Number of severe hypoglycaemic values as a fraction of all blood glucose measurements during the intervention

    Measured: up to 14 days post-randomization

  3. Blood Glucose Level Per Treatment Group during the Intervention

    Mean and median arterial blood glucose level

    Measured: up to 14 days post-randomization

  4. Hyperglycaemic index (HGI)

    Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI)

    Measured: up to 14 days post-randomization

  5. Time in target range

    Measured: up to 14 days post-randomization

  6. Time to target range

    Measured: up to 14 days post-randomization

  7. Daily maximal blood glucose difference

    marker of blood glucose fluctuations

    Measured: up to 14 days post-randomization

  8. Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention

    Number of mild hypoglycaemic values as a fraction of all blood glucose measurements during the intervention

    Measured: up to 14 days post-randomization

  9. Proportion of Patients With Mild Hypoglycaemia (blood glucose level < 70 mg/dL or 3.9 mmol/L) during the Intervention

    Proportion of patients to have had one or more episodes of mild hypoglycaemia during the intervention

    Measured: up to 14 days post-randomization

  10. Interval between blood glucose measurements

    marker of workload

    Measured: up to 14 days post-randomization

  11. Protocol compliance in the intervention group

    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.

    Measured: up to 14 days post-randomization

  12. Overrules in the intervention group

    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

    Measured: up to 14 days post-randomization

  13. Incidence of new infections in the ICU

    The diagnosis of "new infection" will be based on the administration of antibiotics, beyond the prophylactic scope

    Measured: up to 90 days post-randomization

  14. Length of stay in the ICU

    Measured: up to 90 days post-randomization

  15. Length of stay in the hospital

    Measured: up to 90 days post-randomization

  16. Mortality in the ICU

    Measured: up to 90 days post-randomization

  17. Mortality in the hospital

    Measured: up to 90 days post-randomization

  18. Landmark 90-day mortality

    Measured: up to 90 days post-randomization

  19. All direct medical costs from a healthcare payer's perspective

    Measured: up to 90 days post-randomization

  20. Quality of Life

    EuroQol-5D

    Measured: up to 90 days post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionApr 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02056353
Sponsor's protocol ID
LOGIC-Insulin 2.1.1
Other IDs
ML9517, S55613, 80M0563, IWT-TBM 100793
Acronym
LOGIC-2
Status last verified
Jan 2016
First submitted
4 Feb 2014
Last updated
8 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Van Herpe T, Mesotten D, Wouters PJ, Herbots J, Voets E, Buyens J, De Moor B, Van den Berghe G. LOGIC-insulin algorithm-guided versus nurse-directed blood glucose control during critical illness: the LOGIC-1 single-center, randomized, controlled clinical trial. Diabetes Care. 2013 Feb;36(2):188-94. doi: 10.2337/dc12-0584. Epub 2012 Sep 6.

    PubMed 22961576

  • Van Herpe T, De Brabanter J, Beullens M, De Moor B, Van den Berghe G. Glycemic penalty index for adequately assessing and comparing different blood glucose control algorithms. Crit Care. 2008;12(1):R24. doi: 10.1186/cc6800. Epub 2008 Feb 26.

    PubMed 18302732

  • Van den Berghe G, Schetz M, Vlasselaers D, Hermans G, Wilmer A, Bouillon R, Mesotten D. Clinical review: Intensive insulin therapy in critically ill patients: NICE-SUGAR or Leuven blood glucose target? J Clin Endocrinol Metab. 2009 Sep;94(9):3163-70. doi: 10.1210/jc.2009-0663. Epub 2009 Jun 16.

    PubMed 19531590

  • Dubois J, Van Herpe T, van Hooijdonk RT, Wouters R, Coart D, Wouters P, Van Assche A, Veraghtert G, De Moor B, Wauters J, Wilmer A, Schultz MJ, Van den Berghe G, Mesotten D. Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial. Crit Care. 2017 Aug 14;21(1):212. doi: 10.1186/s13054-017-1799-6.

    PubMed 28806982

Questions about this trial

What is this clinical trial studying?

A study testing LOGIC-Insulin algorithm and Paper protocol in people with Critical Illness and Hyperglycemia, run by KU Leuven at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic Penalty Index (GPI) during the Intervention (time frame: up to 14 days post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02056353, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2016.

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