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

Primary Purpose

Critical Illness

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Freestyle Navigator

About this trial

This is an interventional diagnostic trial for Critical Illness focused on measuring hyperglycemia, hypoglycemia, insulin, critical illness, intensive insulin therapy, continuous glucose monitoring, CGM, interstitial fluid glucose, intensive care unit, Blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Freestyle Navigator

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values

Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values

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

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

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

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

Navigator CGM Accuracy by Category

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)

Full Information

NCT ID

NCT00694473

First Posted

June 6, 2008

Last Updated

February 7, 2018

Sponsor

Massachusetts General Hospital

Collaborators

Abbott Diabetes Care

1. Study Identification

Unique Protocol Identification Number

NCT00694473

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Abbott Diabetes Care

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Freestyle Navigator

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Freestyle Navigator

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

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

Time Frame

72 hours

Title

Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values

Description

Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values

Time Frame

72 hours

Title

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

Title

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

Title

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

Description

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

Time Frame

72 hours

Title

Navigator CGM Accuracy by Category

Description

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

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

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