Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery

NCT00694473 | Completed Results

• 1 other identifier: 2007P-002178
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

Critical Illness

Keywords

hyperglycemia; hypoglycemia; insulin; critical illness; intensive insulin therapy; continuous glucose monitoring; CGM; interstitial fluid glucose; intensive care unit; Blood glucose

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).

  72 hours

Secondary Outcomes (6)

• Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl).

  72 hours

• Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values

  72 hours

• Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL)

  72 hours

• Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl)

  72 hours

• Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing:

  72 hours

Study Arms (1)

Freestyle Navigator

EXPERIMENTAL

Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU

Device: Freestyle Navigator

Interventions

Freestyle Navigator DEVICE

Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU

Freestyle Navigator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Abbott Diabetes Care: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Critical Illness; Hyperglycemia; Hypoglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Analysis used recalibrated data from Abbot; possible bias. Time of A-line removal was not always documented; estimate of arterial vs. venous POC reference BGs is estimated.

Results Point of Contact

• Title: Steven J Russell, M.D. PhD
• Organization: Massachusetts General Hospital

sjrussell@mgh.harvard.edu

617-726-8722

Study Officials

• Steven J. Russell, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant in Medicine

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2017
• Last Updated: March 8, 2018
• Results First Posted: October 6, 2017

Record last verified: 2018-02

Locations

US (1)