Insulin Balanced Infusion System Control of Glucose
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- glucose control in target range
研究概览
简要总结
The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; study to develop a closed loop for use in intensive care units and surgery
详细描述
The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9%
- •glucose at time of study > 150 mg/dl
排除标准
- •pregnancy
- •renal or hepatic disease
- •corticosteroids
- •poor intravenous access
- •electrolyte abnormality
研究组 & 干预措施
insulin and glucose infusion
trial of experimental technique in outpatient setting; the group under study will be comprised of type 1 and type 2 diabetic individuals ; they will have automated treatment using algorithm which regulates balancing infusions of glucose and/or insulin intravenously without manual intervention; blood glucose target of 80-180 mg/dl will be guide for the automated system
干预措施: glucose and insulin infusions (Device)
结局指标
主要结局
glucose control in target range
时间窗: data will be evaluated within 6 months after completion of all 40 studies
blood glucose measurements in target range (80-125 mg/dl)
次要结局
- hypoglycemia(data will be evaluated within 6 months after all 40 studies are completed)
研究者
Timothy Valk MD
Chief Scientist
Admetsys Corporation