Critical IllnessLOGIC-1NCT01420302
LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness
A study testing Nurse directed and LOGIC-Insulin in people with Critical Illness, run by Greet Van den Berghe at 1 site in Belgium.
Trial summary
The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Nurse directed and LOGIC-Insulin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Aged 18 years or more
- Admitted to the ICU
- Already receiving or needing insulin infusion for blood glucose control
Who cannot join
- Not critically ill (eating, not mechanically ventilated)
- Pregnant or breastfeeding
- Previous inclusion into the trial
- Included in other trial
- Moribund
- Diabetes coma
- No arterial line available
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Dept Intensive Care Medicine, University Hospitals Leuven
Leuven, 3000
About this study
Official title: LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial
The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients
Read the detailed description
Critical illness typically causes elevated blood glucose concentrations, which have been associated with increased mortality. Strictly normalizing these blood glucose levels by intensive insulin therapy, called tight glycemic control, decreased morbidity and mortality in well-controlled single-center clinical studies. However, multi-center pragmatic trials failed to reproduce those effects, proving that the implementation of tight glycemic control in daily clinical practice is rather difficult.
A computerized algorithm, amongst others, may help the nurses in the titration of insulin to reach normal blood glucose levels and to avoid the particularly worrisome hypoglycemia.
The LOGIC-1 study is a single blinded randomized controlled trial. On admission patients will be randomly assigned to either tight glycemic control (80-110 mg/dL) by the computerized LOGIC-Insulin 3.0 algorithm or to tight glycemic control (80-110 mg/dL) by the nurse-directed protocol. Written informed consent will be asked from the patient in the case of elective surgery requiring post-operative ICU-admission. Proxy informed consent from the closest family member will be asked when the patient was admitted to the ICU in emergency. As blood glucose control by itself is essential in the management of critical illness, random allocation will be done on admission and written informed consent from the closest family member can be deferred to a maximum of 24 hours after randomization. The patient or family member can at all times withdraw from the trial without impact on his treatment. Allocation will be done in blocks (block size is unknown to the care givers responsible for treatment allocation), stratified into cardiac surgery and other reasons for ICU admission, by central computer randomization.
The time window for the study will be 14 days starting from admission to the ICU or when one of the following stop criteria will be met:
- Withdrawal of the informed consent
- Patient starts eating or drinking sugar containing liquids
- Patient is discharged from the ICU (including ICU deaths)
- Removal of arterial line or central venous line
Under the following conditions the study investigator/treating physician will be contacted and, if necessary, patients will be switched from LOGIC-Insulin to nurse-directed blood glucose control:
- Recurrent severe hypoglycemia (<40 mg/dL)
- Refractory hyperglycemia
- Any change in condition that compromises the safety of the patient, as judged by the investigator or treating physician
The common strategy for blood glucose control in both groups involves blood glucose measurements from arterial blood by a blood gas analyzer and the administration of insulin through a central line with a syringe pump.
- Conditions
- Critical Illness
- Being tested
- Nurse directed, LOGIC-Insulin
- Keywords
- critical illness, intensive care, insulin, glucose, algorithm, blood glucose control
- Medical subject headings
- Critical Illness, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse directedProcedure or surgery
Also called Active comparator: titration-guidelines supported TGC
Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL
LOGIC-InsulinProcedure or surgery
Also called software guided TGC
Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
| Study group | Role | What they receive |
|---|---|---|
| LOGIC-Insulin | Experimental | Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm Receives: Procedure: LOGIC-Insulin |
| Nurse-directed | Active comparator | Nurse-directed blood glucose control (80-110 mg/dL) Receives: Procedure: Nurse directed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Penalty Index (GPI) During the Intervention
The GPI is an index (ranging from 0 to 100) derived from the blood glucose values that are outside the target level of 80-110 mg/dL, in both the hyperglycemic and the hypoglycemic ranges. The weight of the penalty score of a blood glucose measurement is proportional to the level of deviation from normoglycemia. The GPI is the average of all penalties that are individually assigned to all blood glucose values, based on an optimized smooth penalty function. Higher GPI scores indicate lower efficacy of glycemic control.
Measured: The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function.
Secondary outcomes (12)
Proportion of Patients With Severe Hypoglycemia (<40 mg/dL) During the Intervention
Proportion of patients to have had one or more episodes of severe hypoglycemia (<40 mg/dL) during the intervention
Measured: up to 14 days post-randomization
Incidence of Severe Hypoglycemia (<40 mg/dL) During the Intervention
Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention
Measured: up to 14 days post-randomization
Blood Glucose Level Per Treatment Group During the Intervention
Measured: up to 14 days post-randomization
Hyperglycemic Index (HGI) During the Intervention
Adequacy of reaching and maintaining the target range for blood glucose during the intervention
Measured: up to 14 days post-randomization
Daily Maximal Blood Glucose Difference During the Intervention
Marker of blood glucose variability
Measured: up to 14 days post-randomization
Proportion of Patients With Common Hypoglycemia (<60 mg/dL) During the Intervention
Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention
Measured: up to 14 days post-randomization
Interval Between Blood Glucose Measurements During the Intervention
Marker of workload
Measured: up to 14 days post-randomization
Percentage of Time in Target Zone (80-110 mg/dL) During the Intervention
Adequacy of reaching and maintaining the target range for blood glucose during the intervention
Measured: up to 14 days post-randomization
Length of Stay in ICU
Measured: up to 90 days post-randomization
Length of Stay in Hospital
Measured: up to 90 days post-randomization
Hospital Mortality
Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors
Measured: up to 90 days post-randomization
Incidence of Common Hypoglycemia (<60 mg/dL) During the Intervention
Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention
Measured: up to 14 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Algorithm-guided versus Nurse directed Blood Glucose Control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greet Van den Berghe
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Innovation by Science and Technology, Flanders, Belgium, Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor-investigator, Greet Van den Berghe, KU Leuven
- Investigators
- Dieter Mesotten, MD, PhD, Study director, KU LeuvenGreet Van den Berghe, MD, PhD, Principal investigator, KU LeuvenTom Van Herpe, Eng, PhD, Principal investigator, KU LeuvenBart De Moor, Eng, PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420302
- Sponsor's protocol ID
- LOGIC-Insulin 1.1.1.
- Other IDs
- S 51956, 80M0437, ML 6079
- Acronym
- LOGIC-1
- Status last verified
- Apr 2024
- First submitted
- 17 Aug 2011
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
PubMed 11794168Van 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 18302732Van Herpe T, De Moor B, Van den Berghe G. Towards closed-loop glycaemic control. Best Pract Res Clin Anaesthesiol. 2009 Mar;23(1):69-80. doi: 10.1016/j.bpa.2008.07.003.
PubMed 19449617Van 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01420302
- Acronym / sponsor ID
- LOGIC-1 / LOGIC-Insulin 1.1.1.
- Conditions
- Critical Illness
- Keywords
- critical illness, intensive care, insulin, glucose, algorithm, blood glucose control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Greet Van den BergheUniversity, hospital or other
- Collaborators
- Agency for Innovation by Science and Technology, Flanders, Belgium, Fund for Scientific Research, Flanders, Belgium
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Aug 2011 (estimated)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients
Detailed description
Critical illness typically causes elevated blood glucose concentrations, which have been associated with increased mortality. Strictly normalizing these blood glucose levels by intensive insulin therapy, called tight glycemic control, decreased morbidity and mortality in well-controlled single-center clinical studies. However, multi-center pragmatic trials failed to reproduce those effects, proving that the implementation of tight glycemic control in daily clinical practice is rather difficult.
A computerized algorithm, amongst others, may help the nurses in the titration of insulin to reach normal blood glucose levels and to avoid the particularly worrisome hypoglycemia.
The LOGIC-1 study is a single blinded randomized controlled trial. On admission patients will be randomly assigned to either tight glycemic control (80-110 mg/dL) by the computerized LOGIC-Insulin 3.0 algorithm or to tight glycemic control (80-110 mg/dL) by the nurse-directed protocol. Written informed consent will be asked from the patient in the case of elective surgery requiring post-operative ICU-admission. Proxy informed consent from the closest family member will be asked when the patient was admitted to the ICU in emergency. As blood glucose control by itself is essential in the management of critical illness, random allocation will be done on admission and written informed consent from the closest family member can be deferred to a maximum of 24 hours after randomization. The patient or family member can at all times withdraw from the trial without impact on his treatment. Allocation will be done in blocks (block size is unknown to the care givers responsible for treatment allocation), stratified into cardiac surgery and other reasons for ICU admission, by central computer randomization.
The time window for the study will be 14 days starting from admission to the ICU or when one of the following stop criteria will be met:
- Withdrawal of the informed consent
- Patient starts eating or drinking sugar containing liquids
- Patient is discharged from the ICU (including ICU deaths)
- Removal of arterial line or central venous line
Under the following conditions the study investigator/treating physician will be contacted and, if necessary, patients will be switched from LOGIC-Insulin to nurse-directed blood glucose control:
- Recurrent severe hypoglycemia (<40 mg/dL)
- Refractory hyperglycemia
- Any change in condition that compromises the safety of the patient, as judged by the investigator or treating physician
The common strategy for blood glucose control in both groups involves blood glucose measurements from arterial blood by a blood gas analyzer and the administration of insulin through a central line with a syringe pump.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Algorithm-guided versus Nurse directed Blood Glucose Control
| Arm | Type | Receives |
|---|---|---|
| LOGIC-Insulin | Experimental | Procedure: LOGIC-InsulinBlood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm |
| Nurse-directed | Active comparator | Procedure: Nurse directedNurse-directed blood glucose control (80-110 mg/dL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or more
- Admitted to the ICU
- Already receiving or needing insulin infusion for blood glucose control
Key exclusion criteria (7 listed)
- Not critically ill (eating, not mechanically ventilated)
- Pregnant or breastfeeding
- Previous inclusion into the trial
- Included in other trial
- Moribund
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse directedAlso: Active comparator: titration-guidelines supported TGCNurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL | Procedure or surgery | Nurse-directed |
| LOGIC-InsulinAlso: software guided TGCBlood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm | Procedure or surgery | LOGIC-Insulin |
Primary outcome
Glycemic Penalty Index (GPI) During the Intervention
Time frame: The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function.
The GPI is an index (ranging from 0 to 100) derived from the blood glucose values that are outside the target level of 80-110 mg/dL, in both the hyperglycemic and the hypoglycemic ranges. The weight of the penalty score of a blood glucose measurement is proportional to the level of deviation from normoglycemia. The GPI is the average of all penalties that are individually assigned to all blood glucose values, based on an optimized smooth penalty function. Higher GPI scores indicate lower efficacy of glycemic control.
12 secondary outcomes
Proportion of Patients With Severe Hypoglycemia (<40 mg/dL) During the Intervention
Time frame: up to 14 days post-randomization
Incidence of Severe Hypoglycemia (<40 mg/dL) During the Intervention
Time frame: up to 14 days post-randomization
Blood Glucose Level Per Treatment Group During the Intervention
Time frame: up to 14 days post-randomization
Hyperglycemic Index (HGI) During the Intervention
Time frame: up to 14 days post-randomization
Daily Maximal Blood Glucose Difference During the Intervention
Time frame: up to 14 days post-randomization
Proportion of Patients With Common Hypoglycemia (<60 mg/dL) During the Intervention
Time frame: up to 14 days post-randomization
Interval Between Blood Glucose Measurements During the Intervention
Time frame: up to 14 days post-randomization
Percentage of Time in Target Zone (80-110 mg/dL) During the Intervention
Time frame: up to 14 days post-randomization
Length of Stay in ICU
Time frame: up to 90 days post-randomization
Length of Stay in Hospital
Time frame: up to 90 days post-randomization
Hospital Mortality
Time frame: up to 90 days post-randomization
Incidence of Common Hypoglycemia (<60 mg/dL) During the Intervention
Time frame: up to 14 days post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11794168van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
- Background: PubMed 18302732Van 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.
- Background: PubMed 19449617Van Herpe T, De Moor B, Van den Berghe G. Towards closed-loop glycaemic control. Best Pract Res Clin Anaesthesiol. 2009 Mar;23(1):69-80. doi: 10.1016/j.bpa.2008.07.003.
- Results publication: PubMed 22961576Van 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.
- Leuven Laboratory Intensive Care MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dieter Mesotten, MD, PhD study director
KU Leuven
Greet Van den Berghe, MD, PhD principal investigator
KU Leuven
Tom Van Herpe, Eng, PhD principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse directed and LOGIC-Insulin in people with Critical Illness, run by Greet Van den Berghe at 1 site in Belgium.
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 3 inclusion and 7 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: The GPI is the average of all penalties that are individually assigned to all blood glucose values obtained up to 14 days post-randomization, based on an optimized smooth penalty function.). 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 NCT01420302, 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 26 Aug 2024.