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 subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.

Detailed Description
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Hyperglycemia is 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. Continuous glucose measurement would facilitate blood glucose control in critically ill patients. Numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. Studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an ICU-setting are rare. Therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.

Official Title
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Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy

Conditions
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Critical Illness

Intervention / Treatment
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* Device: continuous subcutaneous glucose monitoring
* Device: continuous subcutaneous glucose monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted patients expected to stay >48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock. Exclusion Criteria: Admitted patients expected to stay <48h

Ages Eligible for Study
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Minimum Age: 19 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Continuous subcutaneous glucose monitoring in patients without shock | Device: continuous subcutaneous glucose monitoring<br>* continuous subcutaneous glucose monitoring for 72h<br>* Other names: CGMS (Medtronic);|
| Active Comparator: 2<br>continuous subcutaneous glucose monitoring in patients with shock | Device: continuous subcutaneous glucose monitoring<br>* continuous subcutaneous glucose monitoring for 72h<br>* Other names: CGMS (Medtronic);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock |  | 72h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation |  | 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, shock