HyperglycemiaNCT01301053

Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

A study testing Current UVA intensive care insulin protocol and Current UVA intensive care insulin protocol with "brakes" in people with Hyperglycemia and Hypoglycemia, run by University of Virginia at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hyperglycemia, Hypoglycemia
What is being tested?: Current UVA intensive care insulin protocol and Current UVA intensive care insulin protocol with "brakes"
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Sep 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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 y.o. and above
Admitted to an intensive care unit
Patient will require an insulin infusion or is currently prescribed an insulin infusion during the ICU admission.

Who cannot join

Below 18 years of age
Pregnancy
Cancer, active diagnosis
Moribund, Do Not Resuscitate (DNR)/Do Not Intubate (DNI), or death is predicted within 24 hours.
Patients with diabetic ketoacidosis or hyperosmolar hyperglycemic state will be excluded as they are managed on a different insulin protocol
Patients with type 1 diabetes will be excluded as they have unique insulin needs that might confound a pilot study.

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Plan for or anticipated need for any MRI during the study period
Use of acetaminophen within 24 hours prior to enrollment
Use of a medication on the UVa formulary containing maltose, galactose, or xylose that could affect a glucose dehydrogenase pyrroloquinoline quinine (GDH-PQQ) glucose test strip (hepatitis B immune globulin (HepaGamB®), tositumomab [Bexxar®], abatacept [Orencia®], Octagam 5%, and RH immune globulin [WinRho®])
Lack of an appropriate abdominal site for insertion of the Dexcom sensor (e.g. extensive scarring, lack of adequate subcutaneous tissue, local infection, etc.)
Restrictions on use of other drugs or treatments.
According to the Dexcom SEVEN® PLUS and G4 Platinum users manuals, the Dexcom System must be removed prior to Magnetic Resonance Imaging (MRI). Therefore, if the subject requires an MRI, the sensor will be removed from the patient and the reason for removal will be noted. This will not be an Adverse Event, but will conclude the patient's participation in the study.
If the subject requires the use of acetaminophen-containing medications as part of their clinical care while using the system sensor the subject will be out of the study because this drug may affect the performance of the device.
If the subject requires use of a medication on the UVa formulary containing maltose, galactose, or xylose that could affect a glucose dehydrogenase pyrroloquinoline quinine (GDH-PQQ) glucose test strip (hepatitis B immune globulin [HepaGamB®], tositumomab [Bexxar®], abatacept [Orencia®], Octagam 5%, and RH immune globulin [WinRho®]) the subject will be out of the study because this drug may affect the performance of the unit glucometer used for reference values and calibration of the continuous glucose monitor. Study participation would be stopped at that time.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia, Center for Diabetes Technology
Charlottesville, Virginia, 22908

Other trials in United States

About this study

The investigators believe that there remains a gap in implementing insulin infusions in critically ill patients to maximize the benefit and minimize adverse events like episodes of hypoglycemia. Based on the published experience with Continuous Glucose Monitor (CGM), the investigators believe that it is safe to use in critically ill patients. Furthermore, the investigators believe that in combination with a protocol with low risk for hypoglycemia at baseline, that CGM can eliminate this risk fully.

In this study the investigators will:

Study the safety and feasibility of the continuous glucose monitor use in 20 critically ill patients for 7 days (the current maximum recommendation for sensor use). Safety data will include the rate of significant bleeding (hematoma) or infection (cellulitis) from sensor use. Feasibility data will evaluate the amount of missing glucose data over the 7-day sensor life.
Randomize patients treated with the current UVA intensive care insulin protocol for insulin management to the addition of "brakes" that reduce insulin administration based on continuous glucose monitoring data between hourly reference glucose data to prevent episodes of hypoglycemia (blood glucose <70 mg/dl) and severe hypoglycemia (blood glucose <50 mg/dl). This will serve as pilot data to power a larger study in the future.

Read the detailed description

The principle focus of this project is to collect pilot data for a larger study that will test the hypothesis that continuous glucose monitoring (CGM) is safe in critically ill patients and provides important information that can prevent hypoglycemia. This study will determine the feasibility of CGM along with the current UVA intensive care insulin protocol in critically ill hyperglycemic patients as well as to provide some information that may help estimate differences necessary to power future studies.

The following statements summarize the background for this protocol:

Hyperglycemia is prevalent in critical illness, even without prior diabetes, and is associated with increased mortality.
The physiology between critical illness and hyperglycemia may be secondary to inappropriate tissue oxygenation or intense inflammatory mediator release leading to elevated counter-regulatory hormones that stimulate endogenous glucose production and promote insulin resistance.
Early research by Van den Berghe suggested that controlling hyperglycemia by insulin infusion improved outcomes; however, this has been contested in part by the Normoglycemia in Intensive Care Evaluation-Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study.
The results of the NICE-SUGAR study may reflect differences in control glucose range or in the high incidence of hypoglycemia.
Hypoglycemia has been shown to be associated with increased mortality in the ICU.
Glucose variability is associated with ICU mortality.
Continuous glucose monitoring has been shown to be safe for up to 7 days in critically ill patients and may prevent episodes of hypoglycemia

Conditions: Hyperglycemia, Hypoglycemia
Being tested: Current UVA intensive care insulin protocol, Current UVA intensive care insulin protocol with "brakes"
Keywords: hyperglycemia and increased mortality in the ICU, hypoglycemia and increased mortality in the ICU, glucose variability and increased mortality in the ICU, Continuous Glucose Monitoring (CGM) and hypoglycemia, hypoglycemia, reducing ICU mortality
Medical subject headings: Hyperglycemia, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Current UVA intensive care insulin protocolOther
Current UVA intensive care insulin protocol used for insulin management for 12 hours
Current UVA intensive care insulin protocol with "brakes"Other
Current UVA intensive care insulin protocol for insulin management with the addition of "brakes" which reduces insulin administration based on continuous glucose monitoring data between hourly reference glucose data to reduce episodes of hypoglycemia (blood glucose <70 mg/dl)and severe hypoglycemia (blood glucose<50 mg/dl).

Study groups in NCT01301053
Study group	Role	What they receive
Current UVA intensive care insulin protocol without brakes	Other	Studies the safety and feasibility of the continuous glucose monitor in 10 critically ill patients for 7 days and uses the current UVA intensive care insulin for insulin management for 12 hours. Receives: Other: Current UVA intensive care insulin protocol
Current UVA intensive care insulin protocol with brakes	Active comparator	Studies the safety and feasibility of the continuous glucose monitor in 10 critically ill patients for 7 days. Uses the current UVA intensive care insulin protocol for insulin management for 12 hours with the addition of "brakes" that reduce insulin administration based on continuous glucose monitoring data between hourly reference glucose data. Receives: Other: Current UVA intensive care insulin protocol with "brakes"

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and feasibility of the Continuous Glucose Monitor in critically ill hyperglycemic patients for up to 7 days.
To show that Continuous Glucose Monitor sensors are safe in critically ill patients with a low (<1%) rate of adverse events.
Measured: Up to 7 days

Secondary outcomes (1)

The utility of Continuous Glucose Monitor-driven "brakes" to prevent episodes of hypoglycemia using the current UVA intensive care insulin Protocol
Continuous Glucose Monitor can prevent episodes of hypoglycemia (defined as a blood glucose less than 70mg/dl) and severe hypoglycemia (defined as a blood glucose less than 50 mg/dl)
Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Sep 2013

First posted23 Feb 2011 (estimated)
Study startFeb 2011
Primary completionSep 2013 (estimated)
Study completionSep 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HyperglycemiaStudies of the same condition, open and under way.
More trials run by University of VirginiaThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01301053
Sponsor's protocol ID: 15144
Status last verified: Jan 2013
First submitted: 18 Feb 2011
Last updated: 31 Jan 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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All Hyperglycemia trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Intensive Care Unit Continuous Glucose Monitoring
ClinicalTrials.gov ID: NCT01301053
Acronym / sponsor ID: 15144
Conditions: Hyperglycemia, Hypoglycemia
Keywords: hyperglycemia and increased mortality in the ICU, hypoglycemia and increased mortality in the ICU, glucose variability and increased mortality in the ICU, Continuous Glucose Monitoring (CGM) and hypoglycemia, hypoglycemia, reducing ICU mortality
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: U.S. Army Medical Research and Development Command, University of Texas
Study start: Feb 2011
Primary completion: Sep 2013 (estimated)
Study completion: Sep 2013 (estimated)
First posted: 23 Feb 2011 (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.

In this study the investigators will:

Study the safety and feasibility of the continuous glucose monitor use in 20 critically ill patients for 7 days (the current maximum recommendation for sensor use). Safety data will include the rate of significant bleeding (hematoma) or infection (cellulitis) from sensor use. Feasibility data will evaluate the amount of missing glucose data over the 7-day sensor life.
Randomize patients treated with the current UVA intensive care insulin protocol for insulin management to the addition of "brakes" that reduce insulin administration based on continuous glucose monitoring data between hourly reference glucose data to prevent episodes of hypoglycemia (blood glucose <70 mg/dl) and severe hypoglycemia (blood glucose <50 mg/dl). This will serve as pilot data to power a larger study in the future.

Detailed description

The following statements summarize the background for this protocol:

Hyperglycemia is prevalent in critical illness, even without prior diabetes, and is associated with increased mortality.
The physiology between critical illness and hyperglycemia may be secondary to inappropriate tissue oxygenation or intense inflammatory mediator release leading to elevated counter-regulatory hormones that stimulate endogenous glucose production and promote insulin resistance.
Early research by Van den Berghe suggested that controlling hyperglycemia by insulin infusion improved outcomes; however, this has been contested in part by the Normoglycemia in Intensive Care Evaluation-Survival Using Glucose Algorithm Regulation (NICE-SUGAR) study.
The results of the NICE-SUGAR study may reflect differences in control glucose range or in the high incidence of hypoglycemia.
Hypoglycemia has been shown to be associated with increased mortality in the ICU.
Glucose variability is associated with ICU mortality.
Continuous glucose monitoring has been shown to be safe for up to 7 days in critically ill patients and may prevent episodes of hypoglycemia

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Current UVA intensive care insulin protocol without brakes	Other	Other: Current UVA intensive care insulin protocolStudies the safety and feasibility of the continuous glucose monitor in 10 critically ill patients for 7 days and uses the current UVA intensive care insulin for insulin management for 12 hours.
Current UVA intensive care insulin protocol with brakes	Active comparator	Other: Current UVA intensive care insulin protocol with "brakes"Studies the safety and feasibility of the continuous glucose monitor in 10 critically ill patients for 7 days. Uses the current UVA intensive care insulin protocol for insulin management for 12 hours with the addition of "brakes" that reduce insulin administration based on continuous glucose monitoring data between hourly reference glucose data.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18 y.o. and above
Patient will require an insulin infusion or is currently prescribed an insulin infusion during the ICU admission.

Key exclusion criteria (14 listed)

Below 18 years of age
Pregnancy
Cancer, active diagnosis
Moribund, Do Not Resuscitate (DNR)/Do Not Intubate (DNI), or death is predicted within 24 hours.
Patients with diabetic ketoacidosis or hyperosmolar hyperglycemic state will be excluded as they are managed on a different insulin protocol

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
Current UVA intensive care insulin protocolCurrent UVA intensive care insulin protocol used for insulin management for 12 hours	Other	Current UVA intensive care insulin protocol without brakes
Current UVA intensive care insulin protocol with "brakes"Current UVA intensive care insulin protocol for insulin management with the addition of "brakes" which reduces insulin administration based on continuous glucose monitoring data between hourly reference glucose data to reduce episodes of hypoglycemia (blood glucose <70 mg/dl)and severe hypoglycemia (blood glucose<50 mg/dl).	Other	Current UVA intensive care insulin protocol with brakes

Primary outcome

Safety and feasibility of the Continuous Glucose Monitor in critically ill hyperglycemic patients for up to 7 days.
Time frame: Up to 7 days
To show that Continuous Glucose Monitor sensors are safe in critically ill patients with a low (<1%) rate of adverse events.

1 secondary outcome

The utility of Continuous Glucose Monitor-driven "brakes" to prevent episodes of hypoglycemia using the current UVA intensive care insulin Protocol
Time frame: 12 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.

Related trials for Hyperglycemia

Recruiting
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Hyperglycaemia (Non Diabetic), Prediabetes
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight

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.

Stacey Anderson, MD principal investigator

University of Virginia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 31 Jan 2013. 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?

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?

Safety and feasibility of the Continuous Glucose Monitor in critically ill hyperglycemic patients for up to 7 days. (time frame: Up to 7 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 NCT01301053.

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 31 Jan 2013.