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The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.
Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:
Device Performance:
Safety:
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| Measure | Description | Time Frame |
|---|---|---|
| Device Performance: Accuracy of HGMS | Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values]. The portable i-STAT handheld makes patient-side testing easy:
| up to 72 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected | The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants. | up to 72 hours |
Inclusion Criteria:
Subject is at least 18 years old
Subject is admitted to the ICU
Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl
Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours
a. Including patients with no previous diagnosis of Diabetes Mellitus
Subject has anticipated life expectancy greater than 96 hours
Subject has recent platelet count greater than 30,000 per micro-liter
Exclusion Criteria:
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Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Kosiborod, M.D | St Luke's Hospital - Mid America Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Luke's Hospital Mid America Heart Institute | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25452874 | Derived | Kosiborod M, Gottlieb RK, Sekella JA, Peterman D, Grodzinsky A, Kennedy P, Borkon MA. Performance of the Medtronic Sentrino continuous glucose management (CGM) system in the cardiac intensive care unit. BMJ Open Diabetes Res Care. 2014 Jul 21;2(1):e000037. doi: 10.1136/bmjdrc-2014-000037. eCollection 2014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oberservation Arm | To assess safety and device performance for the Hospital Glucose Managment system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oberservation Arm | To assess safety and device performance for the Hospital Glucose Managment system |
| 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 | Device Performance: Accuracy of HGMS | Mean Absolute Relative Difference (MARD), calculated as the absolute difference of [(sensor glucose values - iSTAT glucose values) / iSTAT glucose values]. The portable i-STAT handheld makes patient-side testing easy:
| To assess safety and device performance for the Hospital Glucose Managment system | Posted | Mean | Standard Deviation | percent difference | up to 72 hours |
|
3 days for each subject
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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 | Observation Arm | To assess safety and device performance for the Hospital Glucose Managment system |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Sekella | Medtronic, Inc. | 818-576-5000 | Julie.Sekella@medtronic.com |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected | The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants. | 72 hours |
| Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert | Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same. | Up to 72 hours |
| Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert | Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same. | Up to 72 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Oberservation Arm |
To assess safety and device performance for the Hospital Glucose Managment system |
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| Other Pre-specified | Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected | The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants. | Posted | Number | percentage of total events | up to 72 hours |
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| Other Pre-specified | Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected | The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants. | Posted | Number | percentage of total events | 72 hours |
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| Other Pre-specified | Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert | Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same. | Posted | Number | percentage of all alerts | Up to 72 hours |
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| Other Pre-specified | Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert | Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same. | Posted | Number | percentage of all alerts | Up to 72 hours |
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| 0 |
| 19 |
| 0 |
| 19 |
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