Diabetes
Conditions
Keywords
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
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.
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.
Interventions
DEVICEGuardian® 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.
Sponsors
Medtronic
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Continuous Glucose Monitoring in ICU Continuous glucose monitoring in critically ill patients throughout an intensive care unit (ICU) stay up to 15 days. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Continuous Glucose Monitoring in ICU |
|---|---|
| Age, Continuous | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: Continuously monitor patient's glucose throughout their ICU stay for up to 15 days.
Population: Study was terminated due to insufficient funding and data were not collected.