Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).
研究概览
简要总结
We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with blood glucose (BG) values in surgical and ICU patients with a clinically useful degree of accuracy.
详细描述
Critically ill patients treated with intensive insulin therapy will be monitored for up to 72 hours with the Freestyle Navigator continuous glucose monitor. The device display will be disabled so that continuous glucose monitoring results will not be available to care givers, although low (<60 mg/dL) and high (>250 mg/dL) threshold audio alarms will be enabled. Blood glucose monitoring will be performed according to the usual practice for patients treated with intensive insulin therapy in each intensive care unit, except that additional blood glucose measurements will be performed in response to Freestyle Navigator threshold alarm. All blood glucose management decisions will be made according to intensive insulin therapy protocol in each unit. Freestyle Navigator data will be downloaded from the device after each subject has completed the monitoring period. Blood glucose values obtained in the course of usual care, or in response to Freestyle Navigator threshold alarms, will be compared with time-matched Freestyle Navigator values to assess device accuracy and alarm sensitivity and specificity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients admitted to the general surgical ICU (SICU), medical ICU (MICU), cardiac surgery intensive care unit (CSICU), or neurological intensive care unit (NeuroICU), are being treated with IIT, and have an arterial line in place
- •Patients scheduled for open cardiac surgery or craniotomy that have diabetes mellitus or will be given high dose glucocorticoids. All of these patient will have an arterial line placed at the time of surgery as a part of their usual care
排除标准
- •Age less than 18 years
- •Enrollment in another clinical trial that modifies their glucose management (e.g. trial of modified IIT algorithm or modified glucose monitoring regimen)
- •In order to obtain adequate representation of patients with physiological alterations that might decrease correspondence between blood and ISF glucose, we will recruit 50 subjects in each of five groups:
- •Patients undergoing craniotomy who are either diabetic or will be given high dose corticosteroids
- •Diabetic patients undergoing open cardiac surgery
- •Patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT who are vasopressor dependent, defined by continuous infusion of at least 60 mg/min phenylephrine, 5 mg/min norepinephrine, or 10 mg/kg/min of dopamine, or any combination of two agents for at least 90 continuous minutes in the last 8 hours
- •Patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT with pitting peripheral or dependent edema, defined by the persistence of pitting to at least 5 mm depth for 5 seconds after pressure is applied to a dependent area of the trunk or two limbs.
- •Critically ill patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT who do not fall into groups 1-4.
研究组 & 干预措施
Freestyle Navigator
Continuous monitoring with the Freestyle Navigator for 72 hours or until discharge from the ICU
干预措施: Freestyle Navigator (Device)
结局指标
主要结局
Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).
时间窗: 72 hours
次要结局
- Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl)(72 hours)
- Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl).(72 hours)
- Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values(72 hours)
- Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL)(72 hours)
- Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing:(72 hours)
- Navigator CGM Accuracy by Category(72 hours)
研究者
Steven J. Russell, MD, PhD
Assistant in Medicine
Massachusetts General Hospital