NCT01526044

Brief Summary

The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

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

December 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 27, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

February 1, 2012

Last Update Submit

June 26, 2012

Conditions

HyperglycaemiaHypoglycaemia

Keywords

hyperglycemiahypoglycemiainsulincritical illnessintensive insulin therapycontinuous glucose monitoringCGMinterstitial fluid glucoseintensive care unitBlood glucose

Outcome Measures

Primary Outcomes (1)

  • Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l

Secondary Outcomes (9)

  • Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)

  • Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)

  • - Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)

  • Length of stay in the ICU

  • Mortality

  • +4 more secondary outcomes

Study Arms (2)

Freestyle group

EXPERIMENTAL

Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU

Device: Freestyle Navigator

AccuChek group

ACTIVE COMPARATOR

Glucose levels are being measured by the AccuChek. Patients also get a Freestyle Navigator, which will be blinded. The device will stay on the patient up to 5 days, or until discharge from the ICU.

Device: Freestyle Navigator

Interventions

Freestyle NavigatorDEVICE

Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid

Also known as: Freestyle Navigator, Abbott Diabetes Care
AccuChek groupFreestyle group

Eligibility Criteria

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

You may qualify if:

  • ICU-patients \> 18 years
  • Expected length of stay on the ICU \> 24 hours
  • Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
  • Availability of the Freestyle Navigator

You may not qualify if:

  • Participation in another trial subject to the WMO
  • Lack of informed consent
  • Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht \<0,20 of \> 0,65; paracetamol intoxication)
  • Contraindication for placement of the subcutaneous glucose sensor
  • Participation in this trial during previous ICU admittance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Related Publications (1)

  • Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9.

    PMID: 25139609DERIVED

MeSH Terms

Conditions

HyperglycemiaHypoglycemiaInsulin ResistanceCritical Illness

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • P HJ van der Voort, MD, PhD

    Onze Lieve Vrouwe Gasthuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHJ van der Voort, MD, PhD

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 3, 2012

Study Start

December 1, 2010

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

June 27, 2012

Record last verified: 2012-06

Locations

NL(1)