Continuous Glucose Monitoring in Critically Ill Surgical Patients
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ClinicalTrials.gov Identifier: NCT01108640 |
Recruitment Status
:
Completed
First Posted
: April 22, 2010
Last Update Posted
: June 16, 2014
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Condition or disease |
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Hyperglycemia |

Study Type : | Observational |
Actual Enrollment : | 24 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Continuous Glucose Monitoring in Critically Ill Surgical Patients |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |
Group/Cohort |
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Elective surgical patients |
Massive resuscitation patients |
surgical patients on pressors |
- Concordance of continuous glucose monitor with standard capillary and arterial blood glucose [ Time Frame: 9 months ]Data from each sensor will be downloaded and blood glucose values obtained using proprietary software from Medtronic. Because the CGMS system records glucose readings every 5 minutes, capillary or arterial glucose samples obtained will be compared with the closest CGMS reading within 2.5 minutes of the time the sample was obtained. This will generate a set of paired glucose levels for analysis.
- Safety of the sensor in terms of infection or bleeding at the insertion site [ Time Frame: 9 months ]The monitor insertion site will be observed by the bedside nurse for infectious or bleeding complications

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Septic surgical patients,
- Surgical patients undergoing massive resuscitation,
- Elective surgical patients.
Exclusion Criteria:
- Pregnancy,
- No safe location to place a sensor (skin disorder in areas of potential placement, minimal subcutaneous tissue),
- Patient/surrogate declines to participate,
- Patients speaking a language other than English or Spanish.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108640
United States, Connecticut | |
Yale New Haven Hospital | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Kevin M Schuster, MD | Yale University |
Publications of Results:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01108640 History of Changes |
Other Study ID Numbers: |
0912006043 |
First Posted: | April 22, 2010 Key Record Dates |
Last Update Posted: | June 16, 2014 |
Last Verified: | June 2014 |
Additional relevant MeSH terms:
Critical Illness Hyperglycemia Disease Attributes |
Pathologic Processes Glucose Metabolism Disorders Metabolic Diseases |