An Early Feasibility Study to Evaluate Basal Initialization Parameters 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 study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.
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 AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component.
干预措施: AID System (Device)
AID System Containing Insulin Lispro
The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) 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 (5 Days)
Number of AEs
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
时间窗: In-Patient Period (5 Days)
CGM measured percentage of time \<70 milligrams per deciliter (mg/dL)
次要结局
未报告次要终点