Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 36
- 主要终点
- Primary Safety Endpoint - Change in HbA1c
研究概览
简要总结
This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.
详细描述
This global study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed 780G system using Fiasp insulin as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.
A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 investigational centers across the United States, Canada, and Australia in order to have 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the adult age group (18 years or older)
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
- 7 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Safety Endpoint - Change in HbA1c
时间窗: 3 months
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])
时间窗: Last 6-7 weeks of 3-month study period
The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]). Non-inferiority test.
次要结局
- Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L])(Last 6-7 weeks of 3 month study period)
- Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L])(Last 6-7 weeks of 3 month study period)