In-Clinic Feasibility Study to Observe the Overnight Closed Loop System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)
研究概览
简要总结
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.
详细描述
Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing.
The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American.
The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 2-75 years of age at time of screening
- •A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis
排除标准
- •that are Based on Demands of In-Clinic Study Procedures :
- •Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening
- •Adequate venous access as assessed by investigator or appropriate staff
- •Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
- •Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
- •Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)
研究组 & 干预措施
Hybrid Closed Loop
In-clinic evaluation of the HCL System under various conditions.
干预措施: Hybrid Closed Loop (Device)
结局指标
主要结局
Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)
时间窗: 12 days
time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.
次要结局
- Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase(1 day)
- Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1(1 day)
- Percentage of Time in Euglycemic Range - Phase 2(3 days)
- Percentage of Time in Euglycemic Range - Phase 4(12 days)
- Percentage of Time in Euglycemic Range - Phase 6(7 days)
- Percentage of Time in Euglycemic Range - Phase 7(7 days)
- Percentage of Time in Euglycemic Range - Exploratory A Phase(1 day)