An observational study in Hyperglycemia, sponsored by Medtronic Diabetes. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-07.
Sponsored by Medtronic Diabetes · Observational
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:
699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.
This study's enrollment of 19 is below the median of 100 across 155 observational studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Medtronic Diabetes is the lead sponsor of 61 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 21 (95%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia
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
Exclusion Criteria:
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
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
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
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
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
| Milestone | Oberservation Arm |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
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
| percent difference | Oberservation Arm |
|---|---|
| Device Performance: Accuracy of HGMS | 12.8 ± 9.5 |
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.
| percentage of total events | Oberservation Arm |
|---|---|
| Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected | 16.7 |
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.
| percentage of total events | Oberservation Arm |
|---|---|
| Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected | 88.9 |
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.
| percentage of all alerts | Oberservation Arm |
|---|---|
| Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert | 85.8 |
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.
| percentage of all alerts | Oberservation Arm |
|---|---|
| Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert | 56.5 |
Collected over 3 days for each subject. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Observation Arm | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Oberservation Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 10 |
| Age, Continuous(years) | Oberservation Arm |
|---|---|
| Mean | 64.2 ± 12.1 |
| Sex: Female, Male(Participants) | Oberservation Arm |
|---|---|
| Female | 8 |
| Male | 11 |
| Region of Enrollment(participants) | Oberservation Arm |
|---|---|
| United States | 19 |
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Medtronic Diabetes