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

• ClinicalTrials.gov Identifier: NCT00694473
• Recruitment Status: Completed
• First Posted: June 10, 2008
• Results First Posted: October 6, 2017
• Last Update Posted: March 8, 2018
• Sponsor: Massachusetts General Hospital
• Collaborator: Abbott Diabetes Care
• Information provided by (Responsible Party): Steven J. Russell, MD, PhD, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Critical Illness	Device: Freestyle Navigator	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 76 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery
• Study Start Date: June 2008
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Freestyle Navigator; 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

Outcome Measures

Primary Outcome Measures :

1. Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl). [ Time Frame: 72 hours ]

Secondary Outcome Measures :

1. Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl). [ Time Frame: 72 hours ]
2. Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values [ Time Frame: 72 hours ]
   Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values
3. 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 ]
4. 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 ]
5. Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing: [ Time Frame: 72 hours ]

   Percentage of readings in different blood sugar ranges as shown by point of care testing:

   < 60 mg/dl 61-120 mg/dl 121-180 mg/dl 181-240 lmg/dl >240 mg/dl

6. Navigator CGM Accuracy by Category [ Time Frame: 72 hours ]
   Mean Absolute Relative Difference (MARD) between the Navigator CGM and reference blood glucose values by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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:

1. Patients undergoing craniotomy who are either diabetic or will be given high dose corticosteroids
2. Diabetic patients undergoing open cardiac surgery
3. 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
4. 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.
5. 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

Locations

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

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: Steven J. Russell, MD, PhD, Assistant in Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00694473
• Other Study ID Numbers: 2007P-002178
• First Posted: June 10, 2008
• Results First Posted: October 6, 2017
• Last Update Posted: March 8, 2018
• Last Verified: February 2018

Keywords provided by Steven J. Russell, MD, PhD, Massachusetts General Hospital:

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

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes