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| Name | Class |
|---|---|
| Abbott Diabetes Care | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freestyle Navigator | Experimental | Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Freestyle Navigator | Device | Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl). | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Mean Absolute Relative Difference (MARD) of Navigator CGM compared with reference blood glucose values |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Steven J. Russell, M.D., Ph.D. | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Freestyle Navigator | Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
76 were enrolled, analysis was completed for 69
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| ID | Title | Description |
|---|---|---|
| BG000 | Freestyle Navigator | Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl). | This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity. | Posted | 72 hours |
|
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Freestyle Navigator | Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU Freestyle Navigator: Continuous glucose monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding at Insertion Site | Injury, poisoning and procedural complications | Non-systematic Assessment | Bleeding at the insertion site of the subcutaneous sensor |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven J Russell, M.D. PhD | Massachusetts General Hospital | 617-726-8722 | sjrussell@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
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| 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: | 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 | 72 hours |
| 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) | 72 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Secondary | Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl). | This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia | Posted | 72 hours |
|
|
| Secondary | 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 | Posted | Mean | Full Range | percent absolute relative difference | 72 hours |
|
|
|
| Secondary | Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL) | This measure was not calculated as we did not have sufficient data to calculate sensitivity (not enough hypoglycemia) and discordant BG check times to calculate specificity. | Posted | 72 hours |
|
|
| Secondary | Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl) | This measure was not calculated as we did not have sufficient data to calculate sensitivity and inappropriate BG check times to calculate specificity and few trends towards hyperglycemia | Posted | 72 hours |
|
|
| Secondary | 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 | Posted | Number | percentage of readings | 72 hours |
|
|
|
| Secondary | 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) | MARD by category (1, Neurosurgery; 2, Cardiac Surgery; 3, Hypotensive/Vasopressor; 4, Edema; 5, None of the Above) | Posted | Mean | Standard Deviation | percent absolute relative difference | 72 hours |
|
|
|
| 1 |
| 69 |
| 0 |
| 69 |
| 5 |
| 69 |
|
| Culture proven bacteremia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| Title | Measurements |
|---|---|
|
| 181-240mg/dl |
|
| >240mg/dl |
|
| Title | Measurements |
|---|---|
|
| Edema |
|
| None |
|