Continuous Glucose Monitoring in Islet Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Percentage Time in Range 70-180 mg/dL by CGM
研究概览
简要总结
A study assessing glucose variability in subjects with Type 1 Diabetes who have had islet transplant.
详细描述
Subjects who have an Islet Transplantation may have several outcomes including time when insulin is not required followed in some cases by additional insulin for glucose control as patients get further away from transplantation. It is unclear what role automated insulin delivery systems will have in addressing glucose variability in this group of patients who may have some amount of islet function. As a precursor to understanding ways in which automated insulin delivery systems may need to be adapted, we propose to gather data on glucose variability and insulin regimens in individuals who have undergone an islet transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Type 1 Diabetes Mellitus
- •Recipient of Islet Transplantation
- •Age 18 or older
- •Females, not currently know to be pregnant
- •Demonstration of proper mental status and cognition for the study
- •Understanding and willingness to follow the protocol and informed consent form
- •Access to the internet and willingness to upload data during the study, including use of personal laptop
排除标准
- •Pregnancy and intent to become pregnant during trial
- •Use of acetaminophen (such as Tylenol)
- •Current enrollment in another intervention clinical trial that affects glucose variability
结局指标
主要结局
Percentage Time in Range 70-180 mg/dL by CGM
时间窗: 28-90 days
Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL
次要结局
- Percentage Time in Range <70 mg/dL by CGM(28-90 days)
研究者
Sue Brown
Principal Investigator
University of Virginia