Hyperglycemia
Conditions
Keywords
Medtronic, Diabetes, Hospital, Continuous Glucose Monitor, Intensive Care Unit
Brief summary
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.
Detailed description
Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following: 1. Device Performance: * Functionality of HGMS * Alerts/Alarms Specificity and Sensitivity * System Workflow 2. Safety: * Descriptive statistics will be used to characterize safety events * Moderate and severe anticipated device and procedure related adverse events * All serious adverse events and unanticipated adverse device effects related events
Interventions
None listed
Sponsors
Medtronic Diabetes
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years old 2. Subject is admitted to the ICU 3. Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl 4. 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 5. Subject has anticipated life expectancy greater than 96 hours 6. Subject has recent platelet count greater than 30,000 per micro-liter
Exclusion criteria
1. Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study 2. Subject is currently participating in another investigational drug or device study 3. Subject is pregnant, as determined by hospital admission 4. Subject is receiving treatment that includes Hydroxyurea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance: Accuracy of HGMS | up to 72 hours | 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: * Requires no special sample preparation or user calibration; maintenance is minimal * Weighs 18 ounces, making it portable * Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results: * The system prompts users step by step through the testing process * Operator and patient information can be entered via barcode scanner * Operator lockout prevents unauthorized users from performing or viewing test results * Test results are uploaded automatically when the i-STAT handheld is placed in a downloader |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected | up to 72 hours | 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. |
| Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected | 72 hours | 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. |
| Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert | Up to 72 hours | 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. |
| Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert | Up to 72 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oberservation Arm To assess safety and device performance for the Hospital Glucose Managment system | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Oberservation Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 64.2 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
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: * Requires no special sample preparation or user calibration; maintenance is minimal * Weighs 18 ounces, making it portable * Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results: * The system prompts users step by step through the testing process * Operator and patient information can be entered via barcode scanner * Operator lockout prevents unauthorized users from performing or viewing test results * Test results are uploaded automatically when the i-STAT handheld is placed in a downloader
Time frame: up to 72 hours
Population: To assess safety and device performance for the Hospital Glucose Managment system
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oberservation Arm | Device Performance: Accuracy of HGMS | 12.8 percent difference | Standard Deviation 9.5 |
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.
Time frame: 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oberservation Arm | Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected | 88.9 percentage of total events |
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.
Time frame: Up to 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oberservation Arm | Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert | 56.5 percentage of all alerts |
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.
Time frame: up to 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oberservation Arm | Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected | 16.7 percentage of total events |
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.
Time frame: Up to 72 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Oberservation Arm | Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert | 85.8 percentage of all alerts |