Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
研究概览
简要总结
The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.
详细描述
During this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system.
The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and for management of the basal insulin needs. Patients will come for two closed-loop admissions of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be aged between 18 (inclusive) and 65 years old
- •Patient must have been clinically diagnosed with Type 1 diabetes mellitus for at least one year
- •Patient must have been identified as presenting an indication for the DiaPort® system, i.e. showing poor glucose control under Sc insulin delivery as shown by a sustained HbA1C level > 8% and/or high blood glucose variability including recurrent hypoglycemic events. Patient will be eligible for the study because he/she will have a DiaPort implanted.
- •Patient must demonstrate proper mental status and cognition for the study
- •Patient must be affiliated or beneficiary of a social medical insurance
- •Patient has signed informed consent form prior to study entry
排除标准
- •Unwilling to perform repeated glucose checks, consume standardized meals, and/or take insulin as instructed
- •Evidence of cardiovascular event during the previous 6 months, non stabilized retinopathy, or clinically significant screening laboratory abnormalities
- •Pregnancy, breast feeding, or intention of becoming pregnant
- •Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions.
- •Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€
- •Persons deprived of freedom, adults protected by law or vulnerable persons
结局指标
主要结局
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
时间窗: in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl): * in the basal or late postprandial period * in the early postprandial period (first 4 hours). All analyses will be done by using the YSI blood glucose measurements unless otherwise noted.
次要结局
- Mean and standard deviation blood glucose(For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal))
- Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)(during the 2 hospitalisations period when loop is closed (for a total of 24 hours))
- Percentage of time spent in hyperglycemia(in the early postprandial period (first 4 hours after meal) and in the basal or late postprandial period (from 8 hours after meal until next meal))