Multicentre LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness (LOGIC-2) (LOGIC-2)
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ClinicalTrials.gov Identifier: NCT02056353 |
Recruitment Status :
Completed
First Posted : February 6, 2014
Last Update Posted : January 8, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Critical Illness Hyperglycemia Hypoglycemia | Device: LOGIC-Insulin algorithm Device: Paper protocol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1550 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-2 Multicentre Randomized Controlled Trial |
Study Start Date : | February 2014 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Nurse-directed
Blood glucose control guided by paper protocol
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Device: Paper protocol |
Experimental: LOGIC-Insulin
Blood glucose control guided by the LOGIC-Insulin algorithm
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Device: LOGIC-Insulin algorithm |
- 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)
- 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
- 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
- Blood Glucose Level Per Treatment Group during the Intervention [ Time Frame: up to 14 days post-randomization ]Mean and median arterial blood glucose level
- 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)
- Time in target range [ Time Frame: up to 14 days post-randomization ]
- Time to target range [ Time Frame: up to 14 days post-randomization ]
- Daily maximal blood glucose difference [ Time Frame: up to 14 days post-randomization ]marker of blood glucose fluctuations
- 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
- 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
- Interval between blood glucose measurements [ Time Frame: up to 14 days post-randomization ]marker of workload
- 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.
- 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
- 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
- Length of stay in the ICU [ Time Frame: up to 90 days post-randomization ]
- Length of stay in the hospital [ Time Frame: up to 90 days post-randomization ]
- Mortality in the ICU [ Time Frame: up to 90 days post-randomization ]
- Mortality in the hospital [ Time Frame: up to 90 days post-randomization ]
- Landmark 90-day mortality [ Time Frame: up to 90 days post-randomization ]
- All direct medical costs from a healthcare payer's perspective [ Time Frame: up to 90 days post-randomization ]
- Quality of Life [ Time Frame: up to 90 days post-randomization ]EuroQol-5D

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056353
Belgium | |
Jessa Hospital | |
Hasselt, Belgium, 3500 | |
Dept Intensive Care Medicine, University Hospitals Leuven | |
Leuven, Belgium, 3000 | |
Medical Intensive Care, University Hospitals Leuven | |
Leuven, Belgium, 3000 | |
Netherlands | |
Academic Medical Center (AMC) | |
Amsterdam, Netherlands, 1105 |
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Greet Van den Berghe, Prof. Dr., KU Leuven |
ClinicalTrials.gov Identifier: | NCT02056353 |
Other Study ID 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 ) |
First Posted: | February 6, 2014 Key Record Dates |
Last Update Posted: | January 8, 2016 |
Last Verified: | January 2016 |
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