LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness

NCT01420302 | Completed Results DMC

• 4 other identifiers: LOGIC-Insulin 1.1.1.S 5195680M0437ML 6079
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Critical Illness

Keywords

critical illness; intensive care; insulin; glucose; algorithm; blood glucose control

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  up to 14 days post-randomization

• Incidence of Severe Hypoglycemia (<40 mg/dL) During the Intervention

  up to 14 days post-randomization

• Blood Glucose Level Per Treatment Group During the Intervention

  up to 14 days post-randomization

• Hyperglycemic Index (HGI) During the Intervention

  up to 14 days post-randomization

• Daily Maximal Blood Glucose Difference During the Intervention

  up to 14 days post-randomization

Study Arms (2)

LOGIC-Insulin

EXPERIMENTAL

Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm

Procedure: LOGIC-Insulin

Nurse-directed

ACTIVE COMPARATOR

Nurse-directed blood glucose control (80-110 mg/dL)

Procedure: Nurse directed

Interventions

Nurse directed PROCEDURE

Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL

Also known as: Active comparator: titration-guidelines supported TGC

Nurse-directed

LOGIC-Insulin PROCEDURE

Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm

Also known as: software guided TGC

LOGIC-Insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or more
• Admitted to the ICU
• Already receiving or needing insulin infusion for blood glucose control

You may not qualify if:

• Not critically ill (eating, not mechanically ventilated)
• Pregnant or breastfeeding
• Included in other trial
• Moribund
• Diabetes coma
• No arterial line available

Sponsors & Collaborators

• Greet Van den Berghe: lead
• Agency for Innovation by Science and Technology, Flanders, Belgium: collaborator
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

Dept Intensive Care Medicine, University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

• 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: 11794168 BACKGROUND

• 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: 18302732 BACKGROUND

• 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: 19449617 BACKGROUND

• 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.

  PMID: 22961576 RESULT

Related Links

• Leuven Laboratory Intensive Care Medicine

MeSH Terms

Conditions

Critical Illness; Insulin Resistance

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Professor Greet Van den Berghe
• Organization: Department and Laboratory of Intensive Care Medicine KULeuven/UZLeuven

greet.vandenberghe@kuleuven.be

003216344017

Study Officials

• Dieter Mesotten, MD, PhD

  KU Leuven

  STUDY DIRECTOR

• Greet Van den Berghe, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Tom Van Herpe, Eng, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Bart De Moor, Eng, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Dept Intensive Care Medicine

Model Details: Algorithm-guided versus Nurse directed Blood Glucose Control

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 19, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: August 26, 2024
• Results First Posted: August 26, 2024

Record last verified: 2024-04

Locations

BE (1)