SEMI-CLOSED LOOP "FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 14
- 主要终点
- Percentage of data collected
研究概览
简要总结
The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients with diabetes type 1 Treaty by external insulin pump
- •Duration of diabetes than 2 years or c indosable peptide
- •Practicing insulin functional (IF) or food plan sets
- •Patient having a HbA1c < 10%
- •Patient age over 18 years
- •Patient having signed the form of collection of free consent and informed
- •Patient affiliated with the social security
排除标准
- •Patients with diabetes type 2
- •Patient pregnant or likely to be
- •All serious pathologies that can interfere with the study (in particular kidney or heart failure)
- •Psychiatric pathologies incompatible with the study
结局指标
主要结局
Percentage of data collected
时间窗: Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours)
The aim of the study is data collection of patient blood glucose and insulin in patients treated with continuous subcutaneous infusion insulin pump with a patchpump (JewelPUMPTM Debiotech) and equipped with two glucose sensors for the development of the control algorithm glucose. Blood sample are done every hour (achievement of glucose and insulin assays) ans every 15 minutes during 2 hours after meals.
次要结局
未报告次要终点