NCT00464529

Brief Summary

The purpose of this study is to determine the safety and accuracy of the Real-Time Continuous Glucose monitoring System (RT-CGMS)in measuring glucose in patients scheduled for surgery; before, during and after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 20, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 7, 2007

Status Verified

May 1, 2007

First QC Date

April 20, 2007

Last Update Submit

November 6, 2007

Conditions

Glucose Metabolism DisordersPerioperative Care

Keywords

blood glucosehyperglycemiahypoglycemiaPerioperative careinpatient

Interventions

Real-Time Continuous Glucose monitoring System (RT-CGMS)DEVICE

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective cardiac surgery
  • Age \>18 years
  • Both patients with diabetes mellitus as non-diabetic patients are eligible

You may not qualify if:

  • Failure to obtain informed consent
  • pre-admission insulin treatment for diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Clinics, Weezenlanden location

Zwolle, 8000 GM, Netherlands

Location

MeSH Terms

Conditions

Glucose Metabolism DisordersHyperglycemiaHypoglycemia

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Henk J Bilo, MD PhD, FRCP

    Isala Clinics, Diabetes Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2007

First Posted

April 23, 2007

Study Start

May 1, 2007

Study Completion

October 1, 2007

Last Updated

November 7, 2007

Record last verified: 2007-05

Locations

NL(1)