BurnsPOCNCT00464386
Continuous Glucose Monitoring (POC) in the ICU
A study testing Continuous Glucose Monitoring in people with Burns and Trauma, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial summary
The purpose of this study is to prospectively evaluate whether the addition of continuous glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- What is being tested?
- Continuous Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Dec 2013
- Phase
- Interventional
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- remain 1 week in an ICU
- 18-72 years old
- severe trauma or thermal injury greater than 20% TBSA burn
Who cannot join
- cerebral arterial injury
- myocardial infarction
- pre-existing renal failure or liver failure
- history of hypoglycemia
- history or high risk of seizures
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
Official title: Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)
The purpose of this study is to prospectively evaluate whether the addition of continuous glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control.
Read the detailed description
Severe burns and traumatic injury can be associated with protracted illness and prolonged ICU course. The beneficial effects of strict serum glucose control in critically ill surgical patients have been demonstrated. Continuous glucose monitors may improve glucose control by providing close to real-time glucose measurements, giving the critical care team the ability to react to trends before hypo- or hyperglycemia is reached. These improvements may decrease the morbidity and mortality associated with severe thermal injury, thereby minimizing hospital stay and recovery. Burned and injured soldiers, airmen, sailors, and marines may return to duty in a more expeditious fashion, or at minimum, enjoy a better quality of life after discharge from the intensive care unit.
- Being tested
- Continuous Glucose Monitoring
- Keywords
- Severe burns, Severe Trauma, Closed loop insulin, continuous glucose monitoring
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
Also called Guardian continuous glucose monitor
measure glucose levels on burn patients
| Study group | Role | What they receive |
|---|---|---|
| POC Glucose Testing | No intervention | Hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care). |
| Continuous Glucose Monitoring | Experimental | Continuous arterial glucose monitoring with Guardian sensor + hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care). Receives: Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
To prospectively evaluate the reliability of continuous glucose monitors and the advisability of their use in patients with severe trauma and or thermal injury.
Measured: 90 days
Secondary outcomes (1)
To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startSep 2006
- Primary completionFeb 2009
- Study completionDec 2013
Why it stopped: Study device required infeasible modifications. No patients received device.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Heather Pidcoke, MD, Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464386
- Sponsor's protocol ID
- H-06-011
- Acronym
- POC
- Status last verified
- Feb 2015
- First submitted
- 20 Apr 2007
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kerr D. Continuous blood glucose monitoring: detection and prevention of hypoglycaemia. Int J Clin Pract Suppl. 2001 Sep;(123):43-6.
PubMed 11594298
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)
- ClinicalTrials.gov ID
- NCT00464386
- Acronym / sponsor ID
- POC / H-06-011
- Keywords
- Severe burns, Severe Trauma, Closed loop insulin, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study device required infeasible modifications. No patients received device.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- Sep 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Apr 2007 (estimated)
- 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.
The purpose of this study is to prospectively evaluate whether the addition of continuous glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control.
Detailed description
Severe burns and traumatic injury can be associated with protracted illness and prolonged ICU course. The beneficial effects of strict serum glucose control in critically ill surgical patients have been demonstrated. Continuous glucose monitors may improve glucose control by providing close to real-time glucose measurements, giving the critical care team the ability to react to trends before hypo- or hyperglycemia is reached. These improvements may decrease the morbidity and mortality associated with severe thermal injury, thereby minimizing hospital stay and recovery. Burned and injured soldiers, airmen, sailors, and marines may return to duty in a more expeditious fashion, or at minimum, enjoy a better quality of life after discharge from the intensive care unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POC Glucose Testing | No intervention | –Hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care). |
| Continuous Glucose Monitoring | Experimental | Device: Continuous Glucose MonitoringContinuous arterial glucose monitoring with Guardian sensor + hourly blood glucose monitoring with point of care glucometer (i.e., current standard of care). |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- remain 1 week in an ICU
- 18-72 years old
- severe trauma or thermal injury greater than 20% TBSA burn
Key exclusion criteria (6 listed)
- cerebral arterial injury
- myocardial infarction
- pre-existing renal failure or liver failure
- history of hypoglycemia
- history or high risk of seizures
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 MonitoringAlso: Guardian continuous glucose monitormeasure glucose levels on burn patients | Device | Continuous Glucose Monitoring |
Primary outcome
To prospectively evaluate the reliability of continuous glucose monitors and the advisability of their use in patients with severe trauma and or thermal injury.
Time frame: 90 days
1 secondary outcome
To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Study device required infeasible modifications. No patients received device.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Background: PubMed 11594298Kerr D. Continuous blood glucose monitoring: detection and prevention of hypoglycaemia. Int J Clin Pract Suppl. 2001 Sep;(123):43-6.
- 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.
Heather Pidcoke, MD principal investigator
US Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring in people with Burns and Trauma, run by United States Army Institute of Surgical Research at 1 site in United States.
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 6 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: stopped early, as of the sponsor's last update on 2 May 2016. 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 United States. 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?
The study was stopped early (reason given: Study device required infeasible modifications. No patients received device.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To prospectively evaluate the reliability of continuous glucose monitors and the advisability of their use in patients with severe trauma and or thermal injury. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00464386, which also lists 1 linked publication.
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 May 2016.