Root Cause Determination of Catheter Obstructions

Not Applicable

Terminated

• Conditions: Type1diabetes
• Interventions: Procedure: Collection of intra-peritoneal catheters for insulin infusion

• Registration Number: NCT03230266
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-05-17
• Study Start: 2017-06-02
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-26
• Primary Completion: 2018-12-02
• Study Completion: 2018-12-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
collection	Collection of intra-peritoneal catheters for insulin infusion	collection of biological and device samples

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Associated conditions related to the patient and to infused insulin	one day	Our 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.

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France