Continuous Glucose Monitoring in Critically Ill

NCT00707434 | Terminated Results

• 2 other identifiers: 2007-0616NCI-2011-01085
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Glucose Monitoring Device

EXPERIMENTAL

Continuous glucose monitoring in critically ill patients.

Device: Guardian® blood-sugar monitoring device

Interventions

Guardian® blood-sugar monitoring device 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.

Also known as: Continuous Glucose Monitor, Medtronic Guardian

Glucose Monitoring Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in any of our University of Texas collaborative intensive care units.
• Critically ill patients on an insulin infusion protocol

You may not qualify if:

• Patients or their legal representatives who do not consent
• Patients with large areas of skin affected so as not to allow implantation of device.
• Patients \< 18 years of age

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Medtronic: collaborator

Study Sites (6)

The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Diabetes Mellitus; Critical Illness; Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination led to small numbers of subjects analyzable.

Results Point of Contact

• Title: Clinical Research Operations, Office of VP Clinical Research
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Naifa L. Busaidy, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 23, 2020
• Results First Posted: March 23, 2020

Record last verified: 2020-03

Locations

US (6)