Continuous Glucose Monitoring Device Compared With Point-of-care Glucose Testing in the ICU
18 Years
N/A
Both
Diabetes
Trial Information
Continuous Glucose Monitoring Device Compared With Point-of-care Glucose Testing in the ICU
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)
Outcome Measure:
Mean Relative Difference in Patient Glucose Monitoring
Outcome Time Frame:
Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.
Safety Issue:
No
Principal Investigator
Naifa L. Busaidy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2007-0616
NCT ID:
NCT00707434
Start Date:
June 2008
Completion Date:
Related Keywords:
- Diabetes
- 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
- Critical Illness
Name | Location |
|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| University of Texas Health Science Center at Houston | Houston, Texas 77225 |
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
| University of Texas Medical Branch at Galveston | Galveston, Texas 77555 |
| The University of Texas Southwestern Medical Center at Dallas | Dallas, Texas 75390 |
| University of Texas Health Science Center at Tyler | Tyler, Texas 75708 |
