NCT03230266

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

June 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2018

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

May 17, 2017

Last Update Submit

December 8, 2021

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

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

    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.

    one day

Secondary Outcomes (1)

  • Associated conditions related to the patient and to infused insulin

    one day

Study Arms (1)

collection

OTHER

collection of biological and device samples

Procedure: Collection of intra-peritoneal catheters for insulin infusion

Interventions

Collection of intra-peritoneal catheters for insulin infusionPROCEDURE

Collection of intra-peritoneal catheters for insulin infusion

collection

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

July 26, 2017

Study Start

June 2, 2017

Primary Completion

December 2, 2018

Study Completion

December 2, 2018

Last Updated

December 29, 2021

Record last verified: 2021-12

Locations

FR(1)