Status:
COMPLETED
Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Abbott Diabetes Care
Conditions:
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with blood glucose (BG) va...
Detailed Description
Critically ill patients treated with intensive insulin therapy will be monitored for up to 72 hours with the Freestyle Navigator continuous glucose monitor. The device display will be disabled so that...
Eligibility Criteria
Inclusion
- Patients admitted to the general surgical ICU (SICU), medical ICU (MICU), cardiac surgery intensive care unit (CSICU), or neurological intensive care unit (NeuroICU), are being treated with IIT, and have an arterial line in place
- Patients scheduled for open cardiac surgery or craniotomy that have diabetes mellitus or will be given high dose glucocorticoids. All of these patient will have an arterial line placed at the time of surgery as a part of their usual care
Exclusion
- Age less than 18 years
- Enrollment in another clinical trial that modifies their glucose management (e.g. trial of modified IIT algorithm or modified glucose monitoring regimen)
- In order to obtain adequate representation of patients with physiological alterations that might decrease correspondence between blood and ISF glucose, we will recruit 50 subjects in each of five groups:
- Patients undergoing craniotomy who are either diabetic or will be given high dose corticosteroids
- Diabetic patients undergoing open cardiac surgery
- Patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT who are vasopressor dependent, defined by continuous infusion of at least 60 mg/min phenylephrine, 5 mg/min norepinephrine, or 10 mg/kg/min of dopamine, or any combination of two agents for at least 90 continuous minutes in the last 8 hours
- Patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT with pitting peripheral or dependent edema, defined by the persistence of pitting to at least 5 mm depth for 5 seconds after pressure is applied to a dependent area of the trunk or two limbs.
- Critically ill patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT who do not fall into groups 1-4.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00694473
Start Date
June 1 2008
End Date
December 1 2017
Last Update
March 8 2018
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114