Prospective Longitudinal Observational Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.
研究概览
简要总结
Islet transplantation is associated with drastically improvement glucose control in people with type 1 diabetes. This treatment resulted in the disappearance of severe hypoglycemic events. However, its long-term effectiveness is limited by progressive loss of graft function. Currently, there is no standardized method to detect early dysfunction of the transplanted islets.
This study aims to determine whether a parameter derived from continuous glucose monitoring (CGM), Time in Tight Range (70-140 mg/dL), is associated with pancreatic islet grafts function.
The study hypothesis is that a decrease in Time in Tight Range reflects early loss of islet graft function.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •≥18 years old
- •Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis)
- •Patient who has completed a full cycle of pancreatic islet transplantation, either:
- •Islet Transplantation Alone (ITA), or
- •Islet After Kidney (IAK), or
- •Simultaneous Islet Kidney (SIK), with >10,000 IEQ/kg of recipient body weight, or <10,000 IEQ/kg but having achieved insulin independence
- •Patient who has provided consent for reuse of their data for this research
排除标准
- •Patient refusal to wear continuous glucose monitoring device
- •Pancreatic islet autotransplantation
- •Inability to provide informed consent (e.g., difficulties understanding study information)
- •Patient under judicial protection (safeguard of justice)
- •Patient under guardianship or curatorship
研究组 & 干预措施
Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation
Continuous glucose monitoring (CGM) with TITR measurement
干预措施: Continuous glucose monitoring (CGM) with TITR measurement (Other)
结局指标
主要结局
Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.
时间窗: 1 year post-transplant
次要结局
未报告次要终点