Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

NCT01301053 | Unknown DMC

• 1 other identifier: 15144
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.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.
2. 2.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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  12 hours

Study Arms (2)

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.

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.

Other: Current UVA intensive care insulin protocol with "brakes"

Interventions

Current UVA intensive care insulin protocol OTHER

Current UVA intensive care insulin protocol used for insulin management for 12 hours

Current UVA intensive care insulin protocol without brakes

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).

Current UVA intensive care insulin protocol with brakes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Virginia: lead
• U.S. Army Medical Research and Development Command: collaborator
• University of Texas: collaborator

Study Sites (1)

University of Virginia, Center for Diabetes Technology

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Stacey Anderson, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 23, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 31, 2013

Record last verified: 2013-01

Locations

US (1)