Continuous Glucose Monitoring in Critically Ill Patients

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: continuous subcutaneous glucose monitoring

• Registration Number: NCT00494455
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2006-04
• Study Completion: 2007-03
• Status Verified: 2007-06
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-29
• Last Update Submitted: 2008-02-19
• Last Update Posted: 2008-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	continuous subcutaneous glucose monitoring	Continuous subcutaneous glucose monitoring in patients without shock
2	continuous subcutaneous glucose monitoring	continuous subcutaneous glucose monitoring in patients with shock

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation	72h

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria