Closed-loop Glucose Control for Automated Management of Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Average Blood Glucose Over the Closed-loop Control Period
研究概览
简要总结
We hypothesize that our integrated closed-loop glucose-control system can provide effective, tight, and safe blood glucose (BG) control in type 1 diabetes, thereby establishing the feasibility of closed-loop BG control.
详细描述
This study investigates the utility of an integrated closed-loop glucose-control system for regulating BG in type 1 diabetic subjects. The closed-loop system utilizes sub-cutaneous infusion or insulin and glucagon under the control of a computer algorithm. The only inputs to the algorithm are the subject weight and BG values measured every five minutes. Subjects will undergo up to three 27 hour GCRC admissions during which they will consume three standardized meals. Subject may participate in up to two closed-loop visits (with different insulin lispro pharmacokinetic parameter settings in the control algorithm) and some subjects will participate in open-loop visits. During the closed-loop admission BG will be controlled by the closed-loop system. During the open-loop visit subjects will regulate their own BG in the usual function using their insulin pumps. A small group of non-diabetic subjects will undergo a single 27 hour GCRC admission during which they will eat the same standardized meals. During all admission BG will be measured every 5 minutes and blood will be collected for measurement of insulin and glucagon levels every 10 minutes. During the closed-loop admission of diabetic subjects and the single admission of non-diabetic subjects, three commercially available continuous glucose monitoring devices will be worn. The data from these devices will later be compared to reference BG data.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Closed-loop
Type 1 diabetic subjects under closed-loop blood glucose control
干预措施: Closed-loop (Device)
结局指标
主要结局
Average Blood Glucose Over the Closed-loop Control Period
时间窗: 24 hours
次要结局
- Number of Carbohydrate Interventions(24 hours)
- Sensitivity for Hypo- and Hyperglycemia of the CGM Devices Using the BG Measurement as the Standard(24 hours)
- Peak Hyperglycemia Following Each Meal(After each of 3 meals)
- Percentage of Time Spent Within 70-180 mg/dl(24 hours)
- Percentage of Peak Post-prandial Hyperglycemias < 180 mg/dl (ADA Target)(24 hours)
- Percentage of Time Spent With BG < 70 mg/dl(24 hours)
- Nadir Blood Glucose Level for Each Hypoglycemic Event(24 hours)
- Total Insulin Dose(24 hours)
- Average Glucose and Glycemic Variability (MAGE) During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24-hour Period the Day Prior to Admission as Measured by Navigator CGM Data(24 hours)
- Average Glucose and Glycemic Variability During Closed Loop Control in Diabetic Subjects Compared to the Comparable 24 Hour Period in Non-diabetic Subjects(24 hours)
- Accuracy of the Continuous Glucose Monitor (CGM) Using Blood Glucose Measurement as the Standard(24 hours)
- Percentage of Time Spent in Hyperglycemia (BG> 180 mg/dl) After Meals(After each of 3 meals)
- Total Glucagon Dose(24 hours)
- Blood Glucagon Levels(24 hours)
- Number of Participants Achieving a Stable Glucose Response to Insulin Dosing Around Idle Times Prior to Meals(24 hours)
- Number of Hypoglycemic Events(24 hours)
- Percentage of Time Spent With BG > 180 mg/dl(24 hours)
- Glucagon T-max(24 hours)
- Number of Participants Achieving a Stable Glucose Response to Insulin Dosing(24 hours)
- Insulin and Glucagon Levels During the Closed-loop Admission as Compared to the Comparable 24 Hour Period During the Open Loop Admission of Diabetic Subjects(24 hours)
- Set Point Using CGM Data as the Input to the Controller for Future Studies(24 hours)
- Insulin and Glucagon Levels During Closed Loop and Open Loop Admissions of Diabetic Subjects Compared to the Comparable 24 Hour Period During the Admission of Non-diabetic Subject(24 hours)
研究者
Edward R. Damiano
Associate Professor of Biomedical Engineering
Boston University