An Early Feasibility Study to Evaluate the Predictive Low Glucose Suspend Functionality and Safety in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Adverse Events (AEs)
研究概览
简要总结
The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
- •Have a body mass index of 18.5 to 37 kilogram per meter squared
- •Have a hemoglobin A1c level ≥6.0% and ≤9.0%
排除标准
- •Have known allergies or history of hypersensitivity to insulin lispro
- •Have had an episode of severe hypoglycemia within the past 6 months
- •Have had more than 1 episode of diabetic ketoacidosis in the past 6 months
研究组 & 干预措施
AID System Containing Insulin Lispro
The automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component.
干预措施: AID System (Device)
AID System Containing Insulin Lispro
The automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component.
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Number of Adverse Events (AEs)
时间窗: In-Patient Period (2 Days)
Number of AEs
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
时间窗: In-Patient Period (2 Days)
CGM measured percentage of time \<70 milligrams per deciliter (mg/dL)
次要结局
未报告次要终点