A Multi-Phased, Multi-Center Study to Evaluate Safety and Device Performance of the Medtronic Hospital Glucose Management System (HGMS) in Critically Ill Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Device Performance: Accuracy of HGMS
研究概览
简要总结
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.
详细描述
Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:
- Device Performance:
- Functionality of HGMS
- Alerts/Alarms Specificity and Sensitivity
- System Workflow
- 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
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Subject is currently participating in another investigational drug or device study
- •Subject is pregnant, as determined by hospital admission
- •Subject is receiving treatment that includes Hydroxyurea.
结局指标
主要结局
Device Performance: Accuracy of HGMS
时间窗: 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
次要结局
未报告次要终点