Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To 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
The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
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 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Summary of Key inclusion/
排除标准
- •Inclusion Criteria:
- •Age 21-65 years
- •Type 1 diabetes mellitus for at least one year
- •Using an insulin infusion pump for at least the past 6 months
- •Exclusion Criteria:
- •Pregnancy
- •History of diabetic ketoacidosis (DKA) in the past six months
- •History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months
- •Other Inclusion/Exclusion criteria apply.
- •Please contact clinical study site for complete details.
研究组 & 干预措施
Single Arm
non-randomized, uncontrolled, feasibility study
干预措施: Hypoglycemia-Hyperglycemia Minimizer System (Device)
结局指标
主要结局
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
时间窗: End of Study - in approximately 5 months from first subject enrolled
Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.
次要结局
- Safety Evaluation(End of Study - in approximately 5 months from first subject enrolled)