Accuracy of CGM in the ICU, Compared to Standard of Care

May 31, 2022 updated by: David Thompson, University of British Columbia

Accuracy of Dexcom G6 Continuous Glucose Sensor in the Intensive Care Unit

To determine the performance of the Dexcom CGM device in comparison to arterial glucose samples.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The performance of the Dexcom continuous glucose sensor will be compared with the current standard of care which is arterial glucose samples analyzed on a glucose meter. Subjects will be ICU patients receiving intravenous insulin infusions.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects in the Intensive Care Unit

Description

Inclusion Criteria:

  • minimum age 18 years
  • anticipated to be on an insulin infusion for 3-7 consecutive days
  • 10 of these subjects will be on vasopressors who will be receiving large volume fluid resuscitation

Exclusion Criteria:

  • subjects not on insulin infusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continous Glucose Sensor values (CGM)
Time Frame: 3 to 7 consecutive days
CGM will be compared with arterial glucose values
3 to 7 consecutive days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasopressor Use
Time Frame: 3 to 7 consecutive days
10 of the 20 subjects will be on vasopressors and large volume fluid resuscitation
3 to 7 consecutive days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

DexCom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2020

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H19-02392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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