Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Agreement between algorithm-recommended pump action
研究概览
简要总结
The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.
详细描述
This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
- •Insulin pump therapy for at least 6 months
- •Age ≥18.0 years
- •Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months
排除标准
- •Pregnant (female subjects must have negative urine or serum pregnancy screening test)
- •Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
- •Diabetic ketoacidosis in the month prior to enrollment
- •A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
- •Use of acetaminophen during study participation
- •Current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications
结局指标
主要结局
Agreement between algorithm-recommended pump action
时间窗: 8 hours between 9pm and 5am
To test functionality of the system
Restoration of insulin delivery
时间窗: 8 hours between 9pm and 5am
To test functionality of the system
Suspension of Insulin Delivery
时间窗: 8 hours between 9pm and 5am
To test functionality of the system
次要结局
未报告次要终点