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Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

Primary Purpose

Hyperglycemia, Hypoglycemia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Current UVA intensive care insulin protocol

Current UVA intensive care insulin protocol with "brakes"

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of Virginia, Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Current UVA intensive care insulin protocol without brakes

Current UVA intensive care insulin protocol with brakes

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01301053

First Posted

February 18, 2011

Last Updated

January 30, 2013

Sponsor

University of Virginia

Collaborators

U.S. Army Medical Research and Development Command, University of Texas

1. Study Identification

Unique Protocol Identification Number

NCT01301053

Brief Title

Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

Official Title

Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

U.S. Army Medical Research and Development Command, University of Texas

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Current UVA intensive care insulin protocol without brakes

Arm Type

Other

Arm Description

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.

Arm Title

Current UVA intensive care insulin protocol with brakes

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Current UVA intensive care insulin protocol

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Current UVA intensive care insulin protocol with "brakes"

Intervention Description

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).

Primary Outcome Measure Information:

Title

Safety and feasibility of the Continuous Glucose Monitor in critically ill hyperglycemic patients for up to 7 days.

Description

To show that Continuous Glucose Monitor sensors are safe in critically ill patients with a low (<1%) rate of adverse events.

Time Frame

Up to 7 days

Secondary Outcome Measure Information:

Title

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

Description

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)

Time Frame

12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stacey Anderson, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia, Center for Diabetes Technology

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

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