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Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

NCT ID: NCT00494078

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-08-31

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.

Conditions

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Critical Illness

Keywords

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critical illness hyperglycemia intensive insulin therapy glucose monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.

Group Type ACTIVE_COMPARATOR

Real-time glucose monitoring system (Guardian, Medtronic)

Intervention Type DEVICE

Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.

2

intensive insulin therapy guided by an algorithm

Group Type ACTIVE_COMPARATOR

intensive insulin therapy

Intervention Type DRUG

intensive insulin therapy according to an algorithm

Interventions

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Real-time glucose monitoring system (Guardian, Medtronic)

Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.

Intervention Type DEVICE

intensive insulin therapy

intensive insulin therapy according to an algorithm

Intervention Type DRUG

Other Intervention Names

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Guardian (Medtronic) Novorapid (NovoNordisk) Novorapid (NovoNordisk)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna

Principal Investigators

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Ulrike Holzinger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Medicine III

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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488/2005

Identifier Type: -

Identifier Source: org_study_id