跳至主要内容
临床试验/NCT03230266
NCT03230266终止不适用

Determination of the Root Causes of Obstructions of Catheters in Patients With Type 1 Diabetes Treated by Insulin Implanted Pumps

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2017年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
94
试验地点
2
主要终点
Collection of catheters for intra-peritoneal insulin infusion from implanted pumps presenting obstructions or not : collection of biological and device samples (blood, catheters, insulin)

研究概览

简要总结

During this study, the investigators will perform a collection of biological and device samples (blood, catheters, insulin) in order to investigate the causes of catheter obstructions in patients with type 1 diabetes treated by implanted insulin pumps using intra-peritoneal delivery.

This multi-centre study is interventional with minimal constraints. After an inclusion visit, blood samples and an insulin sample from pump reservoir will be collected. During the following year, if a peritoneal catheter is blocked or changed, the explanted catheter and new blood and insulin samples will be collected for examination of the catheter obstruction and search for patient- or insulin-related reasons for obstructions.

In this study, 140 patients will be investigated.

详细描述

In patients with type 1 diabetes treated by implanted pumps using intra-peritoneal delivery, the incidence of peritoneal catheter obstructions is close to 12 per 100 patient-years. Variability of occurrence is however important between patients. Fibrin, aggregates of insulin and fibrotic tissue have been found inside the catheter lumen at peritoneal tip or forming a capsule around the catheter. This study will investigate with more precision the nature of catheter blockages and look for potential causes of these obstructions such as stability of insulin in the pump reservoir, immune reactions against insulin or catheter components in patient plasma, prothrombotic factors in patient blood. Blood samples and insulin from pump reservoir will be collected at baseline (inclusion). During the following one year period, each catheter presenting an obstruction or needing a change associated with pump change will be collected and explored. Blood and insulin samples will be collected again for comparison with initial samples. Investigations will be performed in collaboration with Pr Burgess' team at the School of Pharmacy of the University of Connecticut. From obtained results, models replicating the conditions of obstruction will be elaborated and tested in rodents at the University of Connecticut. Solutions will be proposed to reduce the occurrence of obstruction of peritoneal catheters as an outcome of the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Collection of catheters for intra-peritoneal insulin infusion from implanted pumps presenting obstructions or not

排除标准

  • 未提供

研究组 & 干预措施

collection

Other

collection of biological and device samples

干预措施: Collection of intra-peritoneal catheters for insulin infusion (Procedure)

结局指标

主要结局

Collection of catheters for intra-peritoneal insulin infusion from implanted pumps presenting obstructions or not : collection of biological and device samples (blood, catheters, insulin)

时间窗: one day

collection of biological and device samples (blood, catheters, insulin) the explanted catheter and new blood and insulin samples will be collected for examination of the catheter obstruction and search for patient- or insulin-related reasons for obstructions.

次要结局

  • Associated conditions related to the patient and to infused insulin(one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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