Use of a Computer-Guided Glucose Management System for Patients Undergoing Blood and Marrow Transplants (BMT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Percentage of glucose values within target range (100-140) by using CGGMS
研究概览
简要总结
This clinical trial studies computer-guided glucose management systems in treating patients with hyperglycemia who have undergone blood and bone marrow transplant. A computer-guided glucose management system may help manage glucose levels in patients who have undergone blood or bone marrow transplant.
详细描述
PRIMARY OBJECTIVES:
I. To examine the ability of computer-guided glucose management system (CGGMS) algorithms to control glucose within or close to current University of Washington Medical Center (UWMC) intensive care unit (ICU) targets (100 to 140 mg/dl) in non-critically ill bone marrow transplant (BMT) adult (age >= 18 years) patients.
OUTLINE:
Patients receive blood glucose management with intravenous (IV) insulin using Glucommander.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Post-transplant adult patients (age >= 18 years) on the BMT Service at UWMC
- •Requiring insulin secondary to:
- •Known history of (h/o) type 2 diabetes mellitus
- •Two blood sugar values > 180 (point of care and/or am lab glycemia)
- •One blood sugar value > 250 (point of care or AM lab glycemia)
排除标准
- •Critically ill patients (intensive care unit [ICU] admissions)
- •Terminally ill patients
- •Eastern Cooperative Oncology Group (ECOG) performance status > 3
- •Previous type 1 diabetes mellitus
- •Cognitively impaired patients, unable to consent
结局指标
主要结局
Percentage of glucose values within target range (100-140) by using CGGMS
时间窗: Up to 2 years
Standard statistical methods for rate and proportions will be used to assess binary outcomes, and standard methods for continuous data will be used for quantitative outcomes.
次要结局
- Percentage of patients who experience hypoglycemia (defined as at least one blood glucose value less than 70)(Up to 2 years)
- Percentage of patients who experience hyperglycemia (defined as at least one blood glucose value greater than 200) 24 hours after initiation of infusion(24 hours after initiation of infusion)
- Percentage of patients who experience severe hyperglycemia (defined as at least one blood glucose value greater than 300) 24 hours after initiation of infusion(24 hours after initiation of infusion)
- Number of values greater than 200 or less than 70 per patient per day of treatment(Up to 2 years)
- Percentage of patients who experience severe hypoglycemia (defined as at least one blood glucose value less than 40)(Up to 2 years)
- Mean time to target range (100-140)(Up to 2 years)
- Glucose variability (defined as standard deviation of individual blood glucose values)(Up to 2 years)
- Nursing satisfaction evaluated by the Glucose Monitoring Tool Trial Evaluation Form(Up to 2 years)