Trial Outcomes & Findings for Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS) (NCT NCT01763567)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

19 participants

Primary outcome timeframe

up to 72 hours

Results posted on

2015-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Oberservation Arm To assess safety and device performance for the Hospital Glucose Managment system
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oberservation Arm n=19 Participants To assess safety and device performance for the Hospital Glucose Managment system
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 72 hours

Population: To assess safety and device performance for the Hospital Glucose Managment system

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

Outcome measures

Outcome measures
Measure	Oberservation Arm n=19 Participants To assess safety and device performance for the Hospital Glucose Managment system
Device Performance: Accuracy of HGMS	12.8 percent difference Standard Deviation 9.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oberservation Arm n=19 Participants To assess safety and device performance for the Hospital Glucose Managment system
Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected	16.7 percentage of total events

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oberservation Arm n=19 Participants To assess safety and device performance for the Hospital Glucose Managment system
Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected	88.9 percentage of total events

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oberservation Arm n=19 Participants To assess safety and device performance for the Hospital Glucose Managment system
Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert	85.8 percentage of all alerts

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Oberservation Arm n=19 Participants To assess safety and device performance for the Hospital Glucose Managment system
Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert	56.5 percentage of all alerts

Adverse Events

Observation Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Sekella

Medtronic, Inc.

Phone: 818-576-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place