Quality Control of Pancreatic Islet Intended to Islet Graft
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Beta-score
研究概览
简要总结
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.
详细描述
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.
The project aims to :
- develop the bio-sensor necessary to measure islet membrane electric potential
- develop interface between bio-sensor and user
- correlate analysis data collected by bio-sensor with metabolic results of islet graft
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP
排除标准
- •Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.
结局指标
主要结局
Beta-score
时间窗: 6 months in average before second islet graft
Beta-score in continuous variable, using the last Beta-score known before the second islet graft. Beta-score is a composite score that reflects pancreatic islet graft function after transplantation and measured from the following criteria: severe hypoglycemia, HbA1c, stimulated C-peptide, fasting glucose, insulin dose or oral diabetes, glycemic variability.
次要结局
未报告次要终点