DiabetesNCT04352907
Accuracy of CGM in the ICU, Compared to Standard of Care
An observational study of Diabetes, run by University of British Columbia at 1 site in Canada.
Trial summary
To determine the performance of the Dexcom CGM device in comparison to arterial glucose samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Continuous Glucose Sensor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2020to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects in the Intensive Care Unit
Who may be able to join
- 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
Who cannot join
- subjects not on insulin infusion
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Continuous Glucose Sensor
- Keywords
- insulin infusion, continuous glucose sensor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose SensorDevice
Continuous glucose sensor results will be compared with arterial glucose samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Continous Glucose Sensor values (CGM)
CGM will be compared with arterial glucose values
Measured: 3 to 7 consecutive days
Secondary outcomes (1)
Vasopressor Use
10 of the 20 subjects will be on vasopressors and large volume fluid resuscitation
Measured: 3 to 7 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start6 Nov 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, David Thompson, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352907
- Sponsor's protocol ID
- H19-02392
- Status last verified
- May 2022
- First submitted
- 15 Apr 2020
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Dexcom G6 Continuous Glucose Sensor in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04352907
- Acronym / sponsor ID
- H19-02392
- Conditions
- Diabetes
- Keywords
- insulin infusion, continuous glucose sensor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the performance of the Dexcom CGM device in comparison to arterial glucose samples.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects in the Intensive Care Unit
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- subjects not on insulin infusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose SensorContinuous glucose sensor results will be compared with arterial glucose samples | Device | – |
Primary outcome
Continous Glucose Sensor values (CGM)
Time frame: 3 to 7 consecutive days
CGM will be compared with arterial glucose values
1 secondary outcome
Vasopressor Use
Time frame: 3 to 7 consecutive days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David M Thompson, MD (604 875 5996, david.thompson@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continous Glucose Sensor values (CGM) (time frame: 3 to 7 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.