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

Study Overview
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Brief Summary
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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.

Official Title
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LOGIC-Insulin Computerized Algorithm-guided Versus Nurse-directed Blood Glucose Control in Critically Ill Patients: the LOGIC-2 Multicentre Randomized Controlled Trial

Conditions
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Critical Illness, Hyperglycemia, Hypoglycemia

Intervention / Treatment
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* Device: LOGIC-Insulin algorithm
* Device: Paper protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nurse-directed<br>Blood glucose control guided by paper protocol | Device: Paper protocol<br> <br> |
| Experimental: LOGIC-Insulin<br>Blood glucose control guided by the LOGIC-Insulin algorithm | Device: LOGIC-Insulin algorithm<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | up to 14 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to 14 days post-randomization | 
| 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 | up to 14 days post-randomization | 
| Blood Glucose Level Per Treatment Group during the Intervention | Mean and median arterial blood glucose level | up to 14 days post-randomization | 
| Hyperglycaemic index (HGI) | Adequacy of reaching and maintaining the target range for blood glucose, as assessed by the Hyperglycaemic index (HGI) | up to 14 days post-randomization | 
| Time in target range |  | up to 14 days post-randomization | 
| Time to target range |  | up to 14 days post-randomization | 
| Daily maximal blood glucose difference | marker of blood glucose fluctuations | up to 14 days post-randomization | 
| 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 | up to 14 days post-randomization | 
| 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 | up to 14 days post-randomization | 
| Interval between blood glucose measurements | marker of workload | up to 14 days post-randomization | 
| 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. | up to 14 days post-randomization | 
| 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 | up to 14 days post-randomization | 
| Incidence of new infections in the ICU | The diagnosis of new infection will be based on the administration of antibiotics, beyond the prophylactic scope | up to 90 days post-randomization | 
| Length of stay in the ICU |  | up to 90 days post-randomization | 
| Length of stay in the hospital |  | up to 90 days post-randomization | 
| Mortality in the ICU |  | up to 90 days post-randomization | 
| Mortality in the hospital |  | up to 90 days post-randomization | 
| Landmark 90-day mortality |  | up to 90 days post-randomization | 
| All direct medical costs from a healthcare payer's perspective |  | up to 90 days post-randomization | 
| Quality of Life | EuroQol-5D | up to 90 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Software, Algorithm, Cardiac surgery