Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.

Detailed Description
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Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.

Official Title
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Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Real-time glucose monitoring system (Guardian, Medtronic)
* Drug: intensive insulin therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted critically ill patients expected to stay >48h on the ICU after initiation of intensive insulin therapy. Age > 18 years. Exclusion Criteria: Admitted patients expected to stay <48h Age ≤ 18 years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system. | Device: Real-time glucose monitoring system (Guardian, Medtronic)<br>* Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.<br>* Other names: Novorapid (NovoNordisk);|
| Active Comparator: 2<br>intensive insulin therapy guided by an algorithm | Drug: intensive insulin therapy<br>* intensive insulin therapy according to an algorithm<br>* Other names: Novorapid (NovoNordisk);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period |  | 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias |  | 72h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring