NCT00494078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

November 30, 2010

Status Verified

January 1, 2009

Enrollment Period

2.2 years

First QC Date

June 27, 2007

Last Update Submit

November 29, 2010

Conditions

Critical Illness

Keywords

critical illnesshyperglycemiaintensive insulin therapyglucose monitoring

Outcome Measures

Primary Outcomes (1)

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

    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

    72h

Study Arms (2)

1

ACTIVE COMPARATOR

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

Device: Real-time glucose monitoring system (Guardian, Medtronic)

2

ACTIVE COMPARATOR

intensive insulin therapy guided by an algorithm

Drug: intensive insulin therapy

Interventions

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.

Also known as: Guardian (Medtronic), Novorapid (NovoNordisk)
1
intensive insulin therapyDRUG

intensive insulin therapy according to an algorithm

Also known as: Novorapid (NovoNordisk)
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted critically ill patients expected to stay \>48h on the ICU after initiation of intensive insulin therapy.
  • Age \> 18 years.

You may not qualify if:

  • Admitted patients expected to stay \<48h
  • Age ≤ 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Critical IllnessHyperglycemia

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Ulrike Holzinger, MD

    Medical University of Vienna, Department of Medicine III

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 29, 2007

Study Start

June 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 30, 2010

Record last verified: 2009-01

Locations

AU(1)