Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: Real-time glucose monitoring system (Guardian, Medtronic); Drug: intensive insulin therapy

• Registration Number: NCT00494078
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-06-27
• Study First Submitted QC: 2007-06-27
• Study First Posted: 2007-06-29
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2009-01
• Last Update Submitted: 2010-11-29
• Last Update Posted: 2010-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Real-time glucose monitoring system (Guardian, Medtronic)	Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.
2	intensive insulin therapy	intensive insulin therapy guided by an algorithm

Primary Outcome Measures

Name	Time	Method
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period	72h

Secondary Outcome Measures

Name	Time	Method
Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias	72h

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria