Clinical Startup of the 670G Closed Loop Insulin Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- percent of time patients are on the closed loop system
研究概览
简要总结
The purpose of this project is to track initiation and the first year of clinical use of the newly FDA approved 670G closed loop insulin delivery system by patients who have requested this system. Our goal is to evaluate our clinical approach to starting this newly approved system. Since the investigators are only following patients who have already decided to start the 670G, the investigator does not assign specific interventions to the subjects of the study; thus this is a Observational study.
详细描述
3.1 Initial Procedures After reviewing the patient's interest and eligibility, the investigators will obtain informed consent and assent as appropriate. The investigators will start the clinical process for starting an insulin infusion pump. This typically involves attending a pre-pump class (for those patients naïve to insulin pump therapy) and starting the process to obtain insurance coverage for the 670G system.
The investigators plan to track the insurance approval process, typically the number of calls and faxes required, as well as the result - approved vs not approved.
3.2 Pump Run-in (for those patients new to insulin infusion pumps) For patients who are insulin pump naïve the investigators will start on 670G insulin pump without the glucose sensor activation as per our existing clinical protocol. This may occur at a group visit.
3.3 Initial Visit
During at an initial visit, the following procedures will be performed:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
- •Clinically planning to and be able to start the Medtronic 670G closed loop system
- •Age greater than 7.00 years at the initiation of the 670G system
- •Total daily insulin use of great than 8.0 units per day over a 1 week period
- •Willing and able (access to internet from home) to download information into the Medtronic CareLink software
排除标准
- •Current or planned pregnancy (for the next 12 months)
结局指标
主要结局
percent of time patients are on the closed loop system
时间窗: 6 month
percent of time patients are on the closed loop system at 6 months after start of closed loop activation with a goal of \>70%.
次要结局
- Percent time in range(6 months)
研究者
Darrell M Wilson
Professor
Stanford University