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NCT04352907 Clinical Trial

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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04352907
Other study ID # H19-02392
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 6, 2020
Est. completion date September 2022

Study information
Verified date May 2022
Source University of British Columbia
Contact David M Thompson, MD
Phone 604 875 5996
Email david.thompson@vch.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuous Glucose Sensor
Continuous glucose sensor results will be compared with arterial glucose samples

Locations
Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (2)
Lead Sponsor Collaborator
University of British Columbia DexCom, Inc.

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Continous Glucose Sensor values (CGM) CGM will be compared with arterial glucose values 3 to 7 consecutive days
Secondary Vasopressor Use 10 of the 20 subjects will be on vasopressors and large volume fluid resuscitation 3 to 7 consecutive days
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