<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/NCT04428762</url>
  </required_header>
  <id_info>
    <org_study_id>0100-18-ASF</org_study_id>
    <nct_id>NCT04428762</nct_id>
  </id_info>
  <brief_title>Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM</brief_title>
  <official_title>Glycemic Control and Quality of Life With i- Port Advance in Pediatric T1DM: Multi Center Crossover and Prospective Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaplan Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Soroka University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assaf-Harofeh Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of T1DM in children, especially infants under 4 years of age, is increasing in&#xD;
      the last decade. Not all patients are willing or able, from different reasons, to be treated&#xD;
      with insulin pumps. This portion of patients' needs subcutaneous insulin injections, at lest&#xD;
      4 injections per day, sometimes up to 8 injections per day.&#xD;
&#xD;
      The recommended treatment is insulin injection before each carbohydrate content meal. Since&#xD;
      each injection may lead to pain, many patients do not inject all recommended doses. The&#xD;
      solution could be: eat with no bolus, or not to correct glucose level to retrain from pain&#xD;
      sensation. I-Port use is able to address this issue by reducing the pain sensation&#xD;
      accompanied with the injection. I-Port advance may give a technological solution to&#xD;
      non-insulin pump T1DM pediatric patients.&#xD;
&#xD;
      There are no reports in the literature of the use of iport in children and youth. This&#xD;
      information is essential since 95% of pediatric diabetes mellitus cases are insulin dependent&#xD;
      and require multiple injections. Better balanced diabetes in childhood may prevent&#xD;
      complications to long range and long-term diabetes therapy. Moreover, if discovered safe, the&#xD;
      iport can be used also for other subcutaneously delivered medication in children, such as&#xD;
      somtostatin analog, human growth hormone and clexane Study is designed as 2 parts. Initial&#xD;
      part is a cross over design to compare between ipor use an injections regarding glucose in&#xD;
      range, side effects and quality of life.&#xD;
&#xD;
      Second part is designed as prospective. To assess glycemic control with iport use or 3 months&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      study withdrawn Nor relevant&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    we decided to change the protocol completely to an RCT.&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Actual">May 1, 2020</completion_date>
  <primary_completion_date type="Actual">May 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This is a multi-center,2 parts study:&#xD;
the first part: randomized crossover study second part: prospective follow-up study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Life quality and satisfaction measures</measure>
    <time_frame>3 months from patient first enrollment</time_frame>
    <description>Life quality measure before and after I-Port Advance use by questionnaire-delta of score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse effect</measure>
    <time_frame>3 months from patient first enrollment</time_frame>
    <description>Number of Adverse effect while using I-port-clinical</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control evaluation</measure>
    <time_frame>3 months from patient first enrollment</time_frame>
    <description>HbA1C% before and after 3 month use of I-port advance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>T1DM</condition>
  <arm_group>
    <arm_group_label>I-Port use arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular injection arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-Port Advance use</intervention_name>
    <description>participants will apply I-port advance for 4 weeks and will inject all insulin through the port. follow up 3 months with/ without i-port.</description>
    <arm_group_label>I-Port use arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with type 1 diabetes mellitus&#xD;
&#xD;
          2. Insulin injection ≥2 per day for at least a week.&#xD;
&#xD;
          3. Use of MDI insulin: Novorapid, Humalog or Apidra.&#xD;
&#xD;
          4. Ability and willingness to perform at least 3 daily self-measured plasma glucose&#xD;
             profiles&#xD;
&#xD;
          5. Ability and willingness to adhere to the protocol. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Insulin pump use&#xD;
&#xD;
          2. Mix insulin use -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 3, 2019</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 7, 2022</last_update_submitted>
  <last_update_submitted_qc>August 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04428762
org study id: 0100-18-ASF
nct id: NCT04428762
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The incidence of T1DM in children, especially infants under 4 years of age, is increasing in
      the last decade. Not all patients are willing or able, from different reasons, to be treated
      with insulin pumps. This portion of patients' needs subcutaneous insulin injections, at lest
      4 injections per day, sometimes up to 8 injections per day.

      The recommended treatment is insulin injection before each carbohydrate content meal. Since
      each injection may lead to pain, many patients do not inject all recommended doses. The
      solution could be: eat with no bolus, or not to correct glucose level to retrain from pain
      sensation. I-Port use is able to address this issue by reducing the pain sensation
      accompanied with the injection. I-Port advance may give a technological solution to
      non-insulin pump T1DM pediatric patients.

      There are no reports in the literature of the use of iport in children and youth. This
      information is essential since 95% of pediatric diabetes mellitus cases are insulin dependent
      and require multiple injections. Better balanced diabetes in childhood may prevent
      complications to long range and long-term diabetes therapy. Moreover, if discovered safe, the
      iport can be used also for other subcutaneously delivered medication in children, such as
      somtostatin analog, human growth hormone and clexane Study is designed as 2 parts. Initial
      part is a cross over design to compare between ipor use an injections regarding glucose in
      range, side effects and quality of life.

      Second part is designed as prospective. To assess glycemic control with iport use or 3 months
      .
study withdrawn Nor relevant
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This is a multi-center,2 parts study:
the first part: randomized crossover study second part: prospective follow-up study
primary purpose: Supportive Care
masking: None (Open Label)
measure: Life quality and satisfaction measures
time frame: 3 months from patient first enrollment
description: Life quality measure before and after I-Port Advance use by questionnaire-delta of score
measure: Adverse effect
time frame: 3 months from patient first enrollment
description: Number of Adverse effect while using I-port-clinical
measure: Glycemic control evaluation
time frame: 3 months from patient first enrollment
description: HbA1C% before and after 3 month use of I-port advance
arm group label: I-Port use arm
arm group type: Experimental
arm group label: Regular injection arm
arm group type: No Intervention
intervention type: Device
intervention name: I-Port Advance use
description: participants will apply I-port advance for 4 weeks and will inject all insulin through the port. follow up 3 months with/ without i-port.
arm group label: I-Port use arm
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
responsible party type: Sponsor