<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03230266</url>
  </required_header>
  <id_info>
    <org_study_id>9802</org_study_id>
    <nct_id>NCT03230266</nct_id>
  </id_info>
  <brief_title>Root Cause Determination of Catheter Obstructions</brief_title>
  <acronym>CATS</acronym>
  <official_title>Determination of the Root Causes of Obstructions of Catheters in Patients With Type 1 Diabetes Treated by Insulin Implanted Pumps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Juvenile Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During this study, the investigators will perform a collection of biological and device&#xD;
      samples (blood, catheters, insulin) in order to investigate the causes of catheter&#xD;
      obstructions in patients with type 1 diabetes treated by implanted insulin pumps using&#xD;
      intra-peritoneal delivery.&#xD;
&#xD;
      This multi-centre study is interventional with minimal constraints. After an inclusion visit,&#xD;
      blood samples and an insulin sample from pump reservoir will be collected. During the&#xD;
      following year, if a peritoneal catheter is blocked or changed, the explanted catheter and&#xD;
      new blood and insulin samples will be collected for examination of the catheter obstruction&#xD;
      and search for patient- or insulin-related reasons for obstructions.&#xD;
&#xD;
      In this study, 140 patients will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In patients with type 1 diabetes treated by implanted pumps using intra-peritoneal delivery,&#xD;
      the incidence of peritoneal catheter obstructions is close to 12 per 100 patient-years.&#xD;
      Variability of occurrence is however important between patients. Fibrin, aggregates of&#xD;
      insulin and fibrotic tissue have been found inside the catheter lumen at peritoneal tip or&#xD;
      forming a capsule around the catheter. This study will investigate with more precision the&#xD;
      nature of catheter blockages and look for potential causes of these obstructions such as&#xD;
      stability of insulin in the pump reservoir, immune reactions against insulin or catheter&#xD;
      components in patient plasma, prothrombotic factors in patient blood. Blood samples and&#xD;
      insulin from pump reservoir will be collected at baseline (inclusion). During the following&#xD;
      one year period, each catheter presenting an obstruction or needing a change associated with&#xD;
      pump change will be collected and explored. Blood and insulin samples will be collected again&#xD;
      for comparison with initial samples. Investigations will be performed in collaboration with&#xD;
      Pr Burgess' team at the School of Pharmacy of the University of Connecticut. From obtained&#xD;
      results, models replicating the conditions of obstruction will be elaborated and tested in&#xD;
      rodents at the University of Connecticut. Solutions will be proposed to reduce the occurrence&#xD;
      of obstruction of peritoneal catheters as an outcome of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inclusion of the last patient&#xD;
  </why_stopped>
  <start_date type="Actual">June 2, 2017</start_date>
  <completion_date type="Actual">December 2, 2018</completion_date>
  <primary_completion_date type="Actual">December 2, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Collection of catheters for intra-peritoneal insulin infusion from implanted pumps presenting obstructions or not : collection of biological and device samples (blood, catheters, insulin)</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Associated conditions related to the patient and to infused insulin</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>collection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>collection of biological and device samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Collection of intra-peritoneal catheters for insulin infusion</intervention_name>
    <description>Collection of intra-peritoneal catheters for insulin infusion</description>
    <arm_group_label>collection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Collection of catheters for intra-peritoneal insulin infusion from implanted pumps&#xD;
             presenting obstructions or not&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 17, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>December 8, 2021</last_update_submitted>
  <last_update_submitted_qc>December 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03230266
org study id: 9802
nct id: NCT03230266
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Collection of catheters for intra-peritoneal insulin infusion from implanted pumps presenting obstructions or not : collection of biological and device samples (blood, catheters, insulin)
time frame: one day
description: 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.
measure: Associated conditions related to the patient and to infused insulin
time frame: one day
description: 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.
arm group label: collection
arm group type: Other
description: collection of biological and device samples
intervention type: Procedure
intervention name: Collection of intra-peritoneal catheters for insulin infusion
description: Collection of intra-peritoneal catheters for insulin infusion
arm group label: collection
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
sharing ipd: Undecided