Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.
详细描述
The CLC is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.These functionalities occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are:
- SAP=sensor-augmented pump only
- USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
- USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 1 diabetes for at least one year
- •using insulin for at least 1 year
- •an insulin pump for at least 6 months
- •willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).
排除标准
- •a medical condition or being been treated with medications that might interfere with the study
研究组 & 干预措施
Group A
Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
- SAP=sensor-augmented pump only
- USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
- USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
干预措施: CLC (Device)
Group B
Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
- SAP=sensor-augmented pump only
- USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight
- USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
干预措施: CLC (Device)
结局指标
主要结局
Hemoglobin A1c
时间窗: 8 weeks
Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.
Time <70 mg/dl by CGM
时间窗: 8 weeks
Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.
次要结局
- Low Blood Glucose Index (LBGI)(8 weeks)
- Hemoglobin A1c by Study Session(8 weeks)
- Time Between 70-180 mg/dL by CGM(8 weeks)
- Time >180 mg/dL by CGM(8 weeks)
- Mean Glucose by CGM(8 weeks)
- CGM <70mg/dL(8 weeks)
- High Blood Glucose Index (HBGI)(8 weeks)
研究者
Sue Brown
Principal Investigator
University of Virginia