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Continuous Glucose Monitoring in Critically Ill

This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, June 2008

Sponsors and Collaborators: M.D. Anderson Cancer Center
Medtronic
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00707434
  Purpose

Primary:

1. To determine reliability of glucose monitoring device as compared with point of care / fingerstick glucose testing.

Secondary:

  1. To determine what conditions, if any, where continuous glucose monitoring device may not be reliable.
  2. To determine if the continuous glucose monitor provides more clinically important information for determining insulin infusion protocol changes as compared with point-of-care testing.

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

Drug Information available for:   Insulin    Dextrose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Single Blind (Investigator), Single Group Assignment, Safety/Efficacy Study
Official Title:   Continuous Glucose Monitoring Device Compared With Point-of-Care Glucose Testing in the ICU

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

Primary Outcome Measures:
  • 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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare blood-sugar measurements from the study device with blood-sugar measurements from the standard "fingerstick" method of blood-sugar testing. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   June 2008
Estimated Primary Completion Date:   June 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1
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.

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 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.

  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

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

Contacts
Contact: Naifa L. Busaidy, MD     713-792-2841    

Locations
United States, Texas
U.T. M.D. Anderson Cancer Center     Recruiting
      Houston, Texas, United States, 77030
      Principal Investigator: Naifa L. Busaidy, MD            
University of Texas Medical Branch at Galveston     Not yet recruiting
      Galveston, Texas, United States, 77555
University of Texas Health Science Center at Houston     Not yet recruiting
      Houston, Texas, United States, 77030
University of Texas Health Science Center at Tyler     Not yet recruiting
      Tyler, Texas, United States, 75708
The University of Texas Southwestern Medical Center at Dallas     Not yet recruiting
      Dallas, Texas, United States, 75390
University of Texas Health Science Center at San Antonio     Not yet recruiting
      San Antonio, Texas, United States, 78229

Sponsors and Collaborators
M.D. Anderson Cancer Center
Medtronic

Investigators
Principal Investigator:     Naifa L. Busaidy, MD     U.T. M.D. Anderson Cancer Center    
  More Information


Responsible Party:   U.T. M.D. Anderson Cancer Center ( Naifa L. Busaidy, M.D. / Assistant Professor )
Study ID Numbers:   2007-0616
First Received:   June 26, 2008
Last Updated:   June 26, 2008
ClinicalTrials.gov Identifier:   NCT00707434
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

Study placed in the following topic categories:
Hyperglycemia
Critical Illness
Diabetes Mellitus
Hypoglycemia
Insulin

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 24, 2008




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