Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Abbott Diabetes Care
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00694473

Purpose

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) values in surgical and ICU patients with a clinically useful degree of accuracy.

Condition	Intervention
Critical Illness	Device: Freestyle Navigator

MedlinePlus related topics: Hypoglycemia

Drug Information available for: Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:	Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Sensitivity and specificity of Navigator threshold alarms for hypoglycemia (<60 mg/dl). [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Sensitivity and specificity of Navigator threshold alarms for hyperglycemia (>250 mg/dl). [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Point-by-point accuracy of the Navigator vs. reference BG [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Sensitivity and specificity of Navigator projected low blood sugar alarm criteria calculated for events defined by a low reference BG value (< 60 mg/dL) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Sensitivity and specificity of Navigator projected high blood sugar alarm criteria calculated for events defined by a high reference BG value (> 250 mg/dl) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Multivariate analysis seeking correlation between accuracy of the Navigator and vasopressor use, abnormal body temperature, peripheral or dependent edema, and severity of illness [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Number and duration of excursions outside of the ICU target range reported by Navigator for at least 15 consecutive minutes and not detected by BG testing [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	June 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Freestyle Navigator: Experimental Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU	Device: Freestyle Navigator Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU

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 continuous glucose monitoring results will not be available to care givers, although low (<60 mg/dL) and high (>250 mg/dL) threshold audio alarms will be enabled. Blood glucose monitoring will be performed according to the usual practice for patients treated with intensive insulin therapy in each intensive care unit, except that additional blood glucose measurements will be performed in response to Freestyle Navigator threshold alarm. All blood glucose management decisions will be made according to intensive insulin therapy protocol in each unit. Freestyle Navigator data will be downloaded from the device after each subject has completed the monitoring period. Blood glucose values obtained in the course of usual care, or in response to Freestyle Navigator threshold alarms, will be compared with time-matched Freestyle Navigator values to assess device accuracy and alarm sensitivity and specificity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694473

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Robert Sutherlin, R.N. 617-724-6237 rsutherlin@partners.org
Sub-Investigator: David M. Nathan, M.D.
Sub-Investigator: Luca Bigatello, M.D.
Sub-Investigator: Arjun Rao, M.B.B.S.
Sub-Investigator: Guy Rordorf, M.D.
Sub-Investigator: Taylor Thompson, M.D.

Sponsors and Collaborators

Massachusetts General Hospital

Abbott Diabetes Care

Investigators

Principal Investigator:

Steven J. Russell, M.D., Ph.D.

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Steven J. Russell )
Study ID Numbers:	2007P-002178
Study First Received:	June 6, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00694473
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

hyperglycemia
hypoglycemia
insulin
critical illness
intensive insulin therapy
continuous glucose monitoring

CGM
interstitial fluid glucose
intensive care unit
Blood glucose
Intensive insulin therapy

Study placed in the following topic categories:

Hyperglycemia
Critical Illness
Hypoglycemia
Insulin

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009