Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting
研究概览
简要总结
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.
详细描述
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-65 years
- •Type 1 diabetes mellitus for at least one year
- •Currently using an insulin infusion pump for at least the past 6 months
排除标准
- •Pregnancy
- •History of Diabetic Ketoacidosis (DKA) in the past six months
- •History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months
结局指标
主要结局
Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting
时间窗: 1 week after subject is enrolled in the study
Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold. Ability of the system to issue timely and accurate warnings.
次要结局
- Capturing the number of Adverse Events as a measure of assessing subject safety(1 week after subject is enrolled in the study)