Continuous Glucose Monitoring in Critically Ill

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00707434
First received: June 26, 2008
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

The goal of this clinical research study is to learn if The Guardian® blood-sugar monitoring device can be used reliably in patients with high blood sugar who are receiving care in the ICU. Researchers will compare blood-sugar measurements from the study device with blood-sugar measurements from the standard "fingerstick" method of blood-sugar testing. This is being done to see if the new device can accurately measure blood sugar.


Condition Intervention
Diabetes
Device: Guardian® blood-sugar monitoring device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: Continuous Glucose Monitoring Device Compared With Point-of-care Glucose Testing in the ICU

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Mean Relative Difference in Patient Glucose Monitoring [ Time Frame: Continuously monitor patient's glucose throughout their ICU stay for up to 15 days. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2008
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucose Monitoring Device
Continuous glucose monitoring in critically ill patients.
Device: Guardian® blood-sugar monitoring device
The device has a small catheter that will be inserted subcutaneous tissue of the subject's abdomen or thigh set to continuously monitor glucose throughout the ICU stay for up to 15 days.
Other Names:
  • Continuous Glucose Monitor
  • Medtronic Guardian

Detailed Description:

The Study Device:

The Guardian® blood-sugar monitoring device is designed to automatically record blood sugar levels many times per hour, without requiring multiple fingersticks. It uses a blood sugar "sensor" (an electronic measuring device) that is about the size of a beeper. The sensor is attached to a small catheter that has a small needle in it. Once the catheter is inserted in the skin, the needle is removed right away.

Use of Study Device:

If you agree to take part in this study, while you are in the ICU, the catheter and needle part of the study device will be inserted under the skin of your abdomen or thigh. The device will automatically measure your blood sugar every 10 seconds so the data can be reviewed by the research staff. The needle will be removed right away. The catheter must be changed every 3 days (+/- 3 days) by the research staff. You will have the study device in place for 15 days (or until you leave the ICU, whichever comes first).

Standard Monitoring of Blood Sugar Levels:

While you are on study, your blood sugar will also be monitored according to the standard of care. This will be in the form of having your blood sugar checked by using a small needle to prick the tip of your finger every hour or more, as necessary.

The blood sugar measurements from the study device will not be used in any way to affect any decisions about your blood sugar monitoring or care.

Length of Study Participation:

After the study device is removed from your body for the last time (after 15 days or when you leave the ICU), you will be considered off study. If intolerable side effects occur, or an infection occurs that seems to have been caused by the study device, you will be taken off study early.

This is an investigational study. The study device is commercially available and FDA approved for monitoring blood sugar levels for outpatient (outside of the hospital) use. Using the device in patients who are in the hospital is considered experimental. At this time, it is only being used in this way in research.

Up to 60 patients will take part in this multicenter study. Up to 25 will be enrolled at M. D. Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients in any of our University of Texas collaborative intensive care units.
  2. Critically ill patients on an insulin infusion protocol

Exclusion Criteria:

  1. Patients or their legal representatives who do not consent
  2. Patients with large areas of skin affected so as not to allow implantation of device.
  3. Patients < 18 years of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707434

Locations
United States, Texas
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
University of Texas Health Science Center at Tyler
Tyler, Texas, United States, 75708
Sponsors and Collaborators
M.D. Anderson Cancer Center
Medtronic
Investigators
Principal Investigator: Naifa L. Busaidy, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00707434     History of Changes
Other Study ID Numbers: 2007-0616
Study First Received: June 26, 2008
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Continuous Glucose Monitor
Medtronic Guardian
Guardian® blood-sugar monitoring device
Glucose Monitoring
Critically Ill
ICU
Intensive Care Unit
Glycemic Excursions
Glucose Control
Glucose Testing
Hyperglycemia
Hypoglycemia
Insulin Infusion

ClinicalTrials.gov processed this record on October 22, 2014