Continuous Glucose Monitoring in Critically Ill

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00707434
Collaborator
Medtronic (Industry)
6
6
1
99
1
0

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Guardian® blood-sugar monitoring device
N/A

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.

  1. Anderson.

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Continuous Glucose Monitoring Device Compared With Point-of-Care Glucose Testing in the ICU
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing [Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 The University of Texas Southwestern Medical Center at Dallas Dallas Texas United States 75390
    2 University of Texas Medical Branch at Galveston Galveston Texas United States 77555
    3 University of Texas Health Science Center at Houston Houston Texas United States 77030
    4 University of Texas MD Anderson Cancer Center Houston Texas United States 77030
    5 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    6 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00707434
    Other Study ID Numbers:
    • 2007-0616
    • NCI-2011-01085
    First Posted:
    Jun 30, 2008
    Last Update Posted:
    Mar 23, 2020
    Last Verified:
    Mar 1, 2020

    Study Results

    Participant Flow

    Recruitment Details Recruitment period: June 12, 2008 to May 19, 2011. All recruitment was done at The University of Texas (UT) and UT MD Anderson Cancer Center.
    Pre-assignment Detail
    Arm/Group Title Continuous Glucose Monitoring Device in ICU
    Arm/Group Description Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
    Period Title: Overall Study
    STARTED 6
    COMPLETED 5
    NOT COMPLETED 1

    Baseline Characteristics

    Arm/Group Title Continuous Glucose Monitoring in ICU
    Arm/Group Description Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
    Overall Participants 6
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    54
    Sex: Female, Male (Count of Participants)
    Female
    2
    33.3%
    Male
    4
    66.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    6
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    6
    100%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    6
    100%

    Outcome Measures

    1. Primary Outcome
    Title Mean Relative Difference in Patient Glucose Monitoring: Continuous Glucose Monitoring (CGM) Device as Compared With Point of Care (POC) Glucose Testing
    Description 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.
    Time Frame Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.

    Outcome Measure Data

    Analysis Population Description
    Study was terminated due to insufficient funding and data were not collected.
    Arm/Group Title Continuous Glucose Monitoring in ICU
    Arm/Group Description Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
    Measure Participants 0

    Adverse Events

    Time Frame Participants monitored for up to 15 days or until leaving the ICU, whichever came first.
    Adverse Event Reporting Description
    Arm/Group Title Continuous Glucose Monitoring in ICU
    Arm/Group Description Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days.
    All Cause Mortality
    Continuous Glucose Monitoring in ICU
    Affected / at Risk (%) # Events
    Total 0/6 (0%)
    Serious Adverse Events
    Continuous Glucose Monitoring in ICU
    Affected / at Risk (%) # Events
    Total 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    Continuous Glucose Monitoring in ICU
    Affected / at Risk (%) # Events
    Total 1/6 (16.7%)
    Injury, poisoning and procedural complications
    Bleeding at device insertion site 1/6 (16.7%) 1

    Limitations/Caveats

    Early termination led to small numbers of subjects analyzable.

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Clinical Research Operations, Office of VP Clinical Research
    Organization UT MD Anderson Cancer Center
    Phone 713-792-7734
    Email CR_Study_Registration@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00707434
    Other Study ID Numbers:
    • 2007-0616
    • NCI-2011-01085
    First Posted:
    Jun 30, 2008
    Last Update Posted:
    Mar 23, 2020
    Last Verified:
    Mar 1, 2020