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Root Cause Determination of Catheter Obstructions

NCT03230266 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-12-29

No results posted yet for this study

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.

Conditions

  • Type1diabetes

Interventions

PROCEDURE

Collection of intra-peritoneal catheters for insulin infusion

Collection of intra-peritoneal catheters for insulin infusion

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-02
Primary Completion
2018-12-02
Completion
2018-12-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230266 on ClinicalTrials.gov