NCT05666479进行中（未招募）不适用
Clinical Effectiveness of Continuous Blood Glucose Monitoring In Patients With Type 2 Diabetes Undergoing Orthopaedic Hip or Knee Replacement Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Accuracy of Real-Time Continuous Glucose Monitoring
研究概览
简要总结
The purpose of this study is to analyze the efficacy and accuracy of real-time continuous glucose monitoring devices (rtCGM) in patients with Type 2 diabetes undergoing inpatient elective hip or knee surgery in the pre-, peri-, and post-operative setting at Stony Brook University Hospital (SBUH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Greater than or equal to 18 years of age
- •Scheduled for elective inpatient hip or knee replacement surgery at Stony Brook University Hospital (SBUH)
- •Clinically diagnosed Type 2 Diabetes at least 6 months prior to surgery
- •Literate and able to provide written informed consent
- •Negative pregnancy test by serum or urine HCG at screening [as documented in subject's medical record) for women of childbearing potential (WCBP)]
排除标准
- •Less than 18 years of age
- •Not scheduled for elective inpatient hip or knee replacement surgery at SBUH
- •No clinical diagnosis of Type 2 diabetes at least 6 months prior to surgery
- •Not literate or unable to provide written informed consent
- •Documented diagnosis of organ failure
- •Documented diagnosis of chronic infection
- •Documented diagnosis of any active malignancy
- •Documented diagnosis of hepatic (liver) dysfunction or cirrhosis
- •Pregnant by serum or urine HCG at screening [as documented in subject's medical record) for women of childbearing potential (WCBP)]
结局指标
主要结局
Accuracy of Real-Time Continuous Glucose Monitoring
时间窗: 10 days
Analyze data from real-time continuous glucose monitoring and point-of-care glucose monitoring (POC-BG). rtCGM data will be matched and compared to POC-BG collected for standard clinical care in the pre-op and post-op settings (i.e. mealtimes, bedtime, and every 6 hours).
次要结局
- Interference of Intraoperative Electrocautery on Real-Time Continuous Glucose Monitoring(60-90 minutes)
- Assess Irreversible Damage/Interference of Real-Time Continuous Glucose Monitoring Devices Caused by Electrocautery(6-7 days)
研究者
Igor Kravets
Associate Professor of Medicine
Stony Brook University
研究点 (1)
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