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
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
研究概览
简要总结
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.
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
- Treatment
- 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
- •Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months
研究组 & 干预措施
Hypo-Hyper Minimizer (HHM) System
干预措施: Hypo-Hyper Minimizer (HHM) System (Device)
结局指标
主要结局
Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
时间窗: After subject is discharged from CRC, 1 week after enrolment
次要结局
- Number of Safety Events and any additional information that can be used for product development(After subject is discharged from CRC, 1 week after enrolment)