Preliminary Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Dosage of plasma insulin concentration and blood glucose every 20 minutes during 6 hours and 40 minutes
研究概览
简要总结
The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is focused on the evaluation of an original control algorithm that computes appropriate subcutaneous insulin infusion in response to continuous glucose measurements The results during a 24-hour closed-loop period will be compared with those of the open-loop. The implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary a phase of identification of the parameters of the model (insulin pharmacokinetics and effect on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of the damping parameters of EDS.
The present study aims to formalize this procedure of identification/optimization of the parameters of the model and controller EDS. They will be determined in type -1 diabetic patients using insulin therapy and under conditions free from disturbances such as those generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will determine this procedure: blood glucose, insulin concentration and insulin doses.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetic patients (age : 18-70)
- •Diabetes duration higher than three years
- •Insulin pump with Humalog®
- •Hospitalized for a 24-hour glucidic fast test
- •Written informed consent
排除标准
- •Pregnancy or nursing
- •Acute infectious disease
- •Corticoid treatment
- •Creatinine clearance <40 ml/mn
- •Patients using Apidra® or Novorapid®
- •People major being the object of a legal protection (safeguard of justice, supervision, trusteeship)
结局指标
主要结局
Dosage of plasma insulin concentration and blood glucose every 20 minutes during 6 hours and 40 minutes
时间窗: 3 months
Identification of the eight parameters of the model including the five parameters of the glucose/insulin metabolism (p1, p2, p3, GB and Ib) and the three parameters of the model of subcutaneous insulin absorption Optimization of the four damping parameters of EDS. These coefficients can be tuned to adjust the damping degree of the error dynamics. These procedures of identification and optimization will be carried out under Matlab® and Simulink®.
次要结局
未报告次要终点