Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-03-06 @ 9:39 PM
Study NCT ID:
NCT01420302
Status:
COMPLETED
Last Update Posted:
2024-08-26
First Post:
2011-08-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'greet.vandenberghe@kuleuven.be', 'phone': '003216344017', 'title': 'Professor Greet Van den Berghe', 'organization': 'Department and Laboratory of Intensive Care Medicine KULeuven/UZLeuven'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LOGIC-Insulin', 'description': 'Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'deathsNumAffected': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nurse-directed', 'description': 'Nurse-directed blood glucose control (80-110 mg/dL)', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'deathsNumAffected': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycemic Penalty Index (GPI) During the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LOGIC-Insulin', 'description': 'Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm\n\nLOGIC-Insulin: Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm'}, {'id': 'OG001', 'title': 'Nurse-directed', 'description': 'Nurse-directed blood glucose control (80-110 mg/dL)\n\nNurse directed: Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '14.5'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '18.5'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '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.', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Severe Hypoglycemia (<40 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Proportion of patients to have had one or more episodes of severe hypoglycemia (\\<40 mg/dL) during the intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Incidence of Severe Hypoglycemia (<40 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Blood Glucose Level Per Treatment Group During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Hyperglycemic Index (HGI) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Adequacy of reaching and maintaining the target range for blood glucose during the intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Daily Maximal Blood Glucose Difference During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Marker of blood glucose variability', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Common Hypoglycemia (<60 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Interval Between Blood Glucose Measurements During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Marker of workload', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Time in Target Zone (80-110 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Adequacy of reaching and maintaining the target range for blood glucose during the intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Length of Stay in ICU', 'timeFrame': 'up to 90 days post-randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Length of Stay in Hospital', 'timeFrame': 'up to 90 days post-randomization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality', 'timeFrame': 'up to 90 days post-randomization', 'description': 'Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Incidence of Common Hypoglycemia (<60 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LOGIC-Insulin', 'description': 'Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm'}, {'id': 'FG001', 'title': 'Nurse-directed', 'description': 'Nurse-directed blood glucose control (80-110 mg/dL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were recruited from 22 August 2011 to 16 December 2011 in a 56-bed ICU of a tertiary referral university hospital'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LOGIC-Insulin', 'description': 'Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm'}, {'id': 'BG001', 'title': 'Nurse-directed', 'description': 'Nurse-directed blood glucose control (80-110 mg/dL)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '15', 'groupId': 'BG000'}, {'value': '62', 'spread': '14', 'groupId': 'BG001'}, {'value': '63', 'spread': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI (kg/m²)', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '25.9', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '26.2', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apache II score (mean SD)', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '10', 'groupId': 'BG000'}, {'value': '24', 'spread': '10', 'groupId': 'BG001'}, {'value': '23', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Acute Physiology and Chronic Health Evaluation (APACHE) II scores range from 0 to 71, with higher scores indicating a greater severity of illness', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Admission type', 'classes': [{'categories': [{'title': 'After cardiac surgery', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Transplantation', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Medical', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Other surgery', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Algorithm-guided versus Nurse directed Blood Glucose Control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2011-08-17', 'resultsFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2011-08-18', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-02', 'studyFirstPostDateStruct': {'date': '2011-08-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic Penalty Index (GPI) During the Intervention', 'timeFrame': '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.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Severe Hypoglycemia (<40 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Proportion of patients to have had one or more episodes of severe hypoglycemia (\\<40 mg/dL) during the intervention'}, {'measure': 'Incidence of Severe Hypoglycemia (<40 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Number of severe hypoglycemic values as a fraction of all blood glucose measurements during the intervention'}, {'measure': 'Blood Glucose Level Per Treatment Group During the Intervention', 'timeFrame': 'up to 14 days post-randomization'}, {'measure': 'Hyperglycemic Index (HGI) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Adequacy of reaching and maintaining the target range for blood glucose during the intervention'}, {'measure': 'Daily Maximal Blood Glucose Difference During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Marker of blood glucose variability'}, {'measure': 'Proportion of Patients With Common Hypoglycemia (<60 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Proportion of patients to have had one or more episodes of common hypoglycemia during the intervention'}, {'measure': 'Interval Between Blood Glucose Measurements During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Marker of workload'}, {'measure': 'Percentage of Time in Target Zone (80-110 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Adequacy of reaching and maintaining the target range for blood glucose during the intervention'}, {'measure': 'Length of Stay in ICU', 'timeFrame': 'up to 90 days post-randomization'}, {'measure': 'Length of Stay in Hospital', 'timeFrame': 'up to 90 days post-randomization'}, {'measure': 'Hospital Mortality', 'timeFrame': 'up to 90 days post-randomization', 'description': 'Patients who will have been discharged from hospital before 90 days post-randomization will be regarded as survivors'}, {'measure': 'Incidence of Common Hypoglycemia (<60 mg/dL) During the Intervention', 'timeFrame': 'up to 14 days post-randomization', 'description': 'Number of common hypoglycemic values as a fraction of all blood glucose measurements during the intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['critical illness', 'intensive care', 'insulin', 'glucose', 'algorithm', 'blood glucose control'], 'conditions': ['Critical Illness']}, 'referencesModule': {'references': [{'pmid': '11794168', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18302732', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19449617', 'type': 'BACKGROUND', 'citation': 'Van 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.'}, {'pmid': '22961576', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.kuleuven.be/licm/', 'label': 'Leuven Laboratory Intensive Care Medicine'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nA 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.\n\nThe 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.\n\nThe 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:\n\n* Withdrawal of the informed consent\n* Patient starts eating or drinking sugar containing liquids\n* Patient is discharged from the ICU (including ICU deaths)\n* Removal of arterial line or central venous line\n\nUnder 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:\n\n* Recurrent severe hypoglycemia (\\<40 mg/dL)\n* Refractory hyperglycemia\n* Any change in condition that compromises the safety of the patient, as judged by the investigator or treating physician\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or more\n* Admitted to the ICU\n* Already receiving or needing insulin infusion for blood glucose control\n\nExclusion Criteria:\n\n* Not critically ill (eating, not mechanically ventilated)\n* Pregnant or breastfeeding\n* Previous inclusion into the trial\n* Included in other trial\n* Moribund\n* Diabetes coma\n* No arterial line available'}, 'identificationModule': {'nctId': 'NCT01420302', 'acronym': 'LOGIC-1', 'briefTitle': 'LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-1 Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'LOGIC-Insulin 1.1.1.'}, 'secondaryIdInfos': [{'id': 'S 51956', 'type': 'OTHER', 'domain': 'University Hospitals Leuven'}, {'id': '80M0437', 'type': 'OTHER', 'domain': 'Belgian Federal Agency for Medicines and Health Products'}, {'id': 'ML 6079', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LOGIC-Insulin', 'description': 'Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm', 'interventionNames': ['Procedure: LOGIC-Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nurse-directed', 'description': 'Nurse-directed blood glucose control (80-110 mg/dL)', 'interventionNames': ['Procedure: Nurse directed']}], 'interventions': [{'name': 'Nurse directed', 'type': 'PROCEDURE', 'otherNames': ['Active comparator: titration-guidelines supported TGC'], 'description': 'Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL', 'armGroupLabels': ['Nurse-directed']}, {'name': 'LOGIC-Insulin', 'type': 'PROCEDURE', 'otherNames': ['software guided TGC'], 'description': 'Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm', 'armGroupLabels': ['LOGIC-Insulin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Dept Intensive Care Medicine, University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Dieter Mesotten, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KU Leuven'}, {'name': 'Greet Van den Berghe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Tom Van Herpe, Eng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Bart De Moor, Eng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Greet Van den Berghe', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Innovation by Science and Technology, Flanders, Belgium', 'class': 'UNKNOWN'}, {'name': 'Fund for Scientific Research, Flanders, Belgium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Dept Intensive Care Medicine', 'investigatorFullName': 'Greet Van den Berghe', 'investigatorAffiliation': 'KU Leuven'}}}}