Skip to main content
OpenTrials
Completed

NCT Number: NCT00494078

Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Illness Disease Attributes Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time glucose monitoring system (Guardian, Medtronic)

Device

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

Other names: Guardian (Medtronic), Novorapid (NovoNordisk)

Intensive insulin therapy

Drug

intensive insulin therapy according to an algorithm

Other names: Novorapid (NovoNordisk)

Primary outcomes

  1. Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period

    Time frame: 72h

Secondary outcomes

  1. Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias

    Time frame: 72h

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 29, 2007
Registry last updated
Nov 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.