Pilot Study of Intensive Care Unit Continuous Glucose Monitoring

• Register: ClinicalTrials.gov
• Last refreshed on: 4 February 2013
• Main ID: NCT01301053
• Date of registration: 18/02/2011
• Primary sponsor: University of Virginia
• Public title: Pilot Study of Intensive Care Unit Continuous Glucose Monitoring
• Scientific title: Pilot Study of Intensive Care Unit Continuous Glucose Monitoring
• Date of first enrolment: February 2011
• Target sample size: 20
• Recruitment status: Enrolling by invitation
• URL: http://clinicaltrials.gov/show/NCT01301053
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Stacey Anderson, MD
• Affiliation: University of Virginia

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hyperglycemia

Hypoglycemia

Intervention(s)

Other: Current UVA intensive care insulin protocol

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

Primary Outcome(s)

Safety and feasibility of the Continuous Glucose Monitor in critically ill hyperglycemic patients for up to 7 days. [Time Frame: Up to 7 days]

Secondary Outcome(s)

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]

Secondary ID(s)

15144

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

U.S. Army Medical Research and Materiel Command

University of Texas