Continuous Glucose Monitoring in Critically Ill

Diabetes Clinical Trial

Official title:

Continuous Glucose Monitoring Device Compared With Point-of-Care Glucose Testing in the ICU

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00707434
• Other study ID #: 2007-0616
• Secondary ID: NCI-2011-01085
• Status: Terminated
• Phase: N/A
• Start date: June 2008
• Est. completion date: September 2016

Study information

• Verified date: March 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing	Mean relative difference will be calculated on a patient level assuming that at least 6 paired measurements will be collected from each patient.; Outcome represents reliability of CGM device as compared with POC glucose testing where glucose values measured by POC will only be compared with the values read by the continuous glucose monitor sensor at the corresponding time points. The primary outcome for each patient is the mean relative difference defined as average of relative difference at each time point, where relative difference at each time point is calculated by taking difference in glucose values between CGM and POC and then divided by POC glucose value.	Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.

External Links

•   University of Texas MD Anderson Cancer Center Website