<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/NCT04421001</url>
  </required_header>
  <id_info>
    <org_study_id>0075-20-ASF</org_study_id>
    <nct_id>NCT04421001</nct_id>
  </id_info>
  <brief_title>RCT for Evaluation of Insulin Administration,While Using the iPORT System</brief_title>
  <official_title>RCT for Evaluation of Insulin Administration, Time in Range of Glucose, Adverse Events and Quality of Life, While Using the iPORT System in Pediatric Population With Recent-onset Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assaf-Harofeh Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 1 diabetes is the most common chronic pediatric autoimmune disease, with a rising&#xD;
      incidence rate in recent years around the world and in Israel Management includes multiple&#xD;
      daily capillary glucose measurements by finger pricks, or interstitial sugar measurements by&#xD;
      sensors, and insulin subcutaneous administration before each meal by injections or by an&#xD;
      insulin pump .&#xD;
&#xD;
      The initial management and teaching of T1D patients and families includes at least 5-6&#xD;
      glucose measurements per day and at least 4 insulin injections per day, while the preferred&#xD;
      guideline should be insulin administration prior to each meal, including morning and&#xD;
      afternoon snacks, very common among pediatric patients attending school curriculum.&#xD;
&#xD;
      The early use of I-port at disease diagnosis may reduces pain, increase the amount of daily&#xD;
      injections, may increase accuracy of insulin administration, and thus improve time in range&#xD;
      from disease diagnosis.&#xD;
&#xD;
      Aims of study:&#xD;
&#xD;
      To assess the efficacy of I-port use in recent onset T1D in a pediatric population, in&#xD;
      increasing insulin administration and possibly improving time in range of glucose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 diabetes is the most common chronic pediatric autoimmune disease, with a rising&#xD;
      incidence rate in recent years around the world and in Israel Management includes multiple&#xD;
      daily capillary glucose measurements by finger pricks, or interstitial sugar measurements by&#xD;
      sensors, and insulin subcutaneous administration before each meal by injections or by an&#xD;
      insulin pump . Treatment goals include several parameters; keeping glucose levels in target&#xD;
      range for longer than 70% of the time, having less than 1% of hypoglycemic episodes, and&#xD;
      maintaining HbA1c less than 7.5%. In the pediatric population, growth parameters, and quality&#xD;
      of life are of major importance in addition. Studies published worldwide in the past decade&#xD;
      indicate that only 37% of the diabetic population achieve glycemic control target are&#xD;
      balanced with the objective of the glycated hemoglobin (HbA1c) below 7.5%, in all suggested&#xD;
      regimens. One of the major obstacles for achieving target goals is the postprandial&#xD;
      hyperglycemia. Post prandial hyperglycemia is related to the timing of insulin administration&#xD;
      and to the amount injected according to carbohydrate content of the meal A significant&#xD;
      association has been demonstrated between missed insulin boluses prior to meals and glycemic&#xD;
      control parameters The initial management and teaching of T1D patients and families includes&#xD;
      at least 5-6 glucose measurements per day and at least 4 insulin injections per day, while&#xD;
      the preferred guideline should be insulin administration prior to each meal, including&#xD;
      morning and afternoon snacks, very common among pediatric patients attending school&#xD;
      curriculum. The reason for those recommendations is based on quality of life consideration,&#xD;
      increasing adherence to management by less daily painful injections. According to ISPAD&#xD;
      recommendations, when using injections, it is suggested to consider the use of a device as&#xD;
      Insuflon (Unomedical) or I-Port (Medtronic) in order to decrease pain, and enable flexibility&#xD;
      of boluses13.&#xD;
&#xD;
      The I-Port system (Medtronic) is intended to allow insulin delivery through the port for 72&#xD;
      hours after port insertion, with one injection, without additional injections or pain. Any&#xD;
      insulin, including several types of insulin is delivered via the same port by using the&#xD;
      standard insulin pens. The use of I-port system may solve the obstacle of multiple painful&#xD;
      daily injections at disease diagnosis, may enable pre-meal administration of insulin before&#xD;
      meals and snacks, may improve quality of life, and most important, may decrease post prandial&#xD;
      glucose excursions. Moreover, one should remember that children cannot decide on the amount&#xD;
      of food prior to meal, and may need for achieving post prandial glucose in range 2 injections&#xD;
      for each meal, one before and addition after a meal, which is hard to adhere with injections.&#xD;
      Furthermore, toddlers receive the insulin injections after meals from fear of not finishing&#xD;
      the meal, thus increasing significantly their post meal glycemic excursion . The early use of&#xD;
      I-port at disease diagnosis may reduces pain, increase the amount of daily injections, may&#xD;
      increase accuracy of insulin administration, and thus improve time in range from disease&#xD;
      diagnosis. Previous report with Insuflon (Unomedical) showed an improvement of 0.7% in HbA1c&#xD;
      , as well as a low rate of pain, a local response, and no blockage15, but its use is not&#xD;
      common in the daily life of the patients in light of lack of comfort in insertion, and&#xD;
      permission to use only one insulin type. The I-port is easier to insert and can be used in&#xD;
      several types of insulin. The device is effective in adult population, approximately 70% to&#xD;
      reduce the pain, about 70% improving quality of life and 70% of patients not felt in its&#xD;
      presence, no change in HbA1c16. Its main side effect is 4% of the reported cases of local&#xD;
      reactions16.There are no reports in the literature of the use of I-port in the pediatric&#xD;
      population.&#xD;
&#xD;
      Technology in T1D has actually provided a solution for those multiple daily injections, by&#xD;
      using an insulin pump 17. However, insulin pump cannot be used immediately, and not by all&#xD;
      patients, and is not funded in many countries. Even in developed countries,asIsrael, it takes&#xD;
      a minimum of 3 months for a patient to start using a pump in real life due to health care&#xD;
      approvals, financial considerations, technology introduction to families, and education for&#xD;
      the life with T1D. However, early control of glucose levels and prevention of hyperglycemic&#xD;
      excursions was proven to prevent short and long term complications, and may lead to better&#xD;
      long-run glycemic control .&#xD;
&#xD;
      The hypothesis is that early introduction of an I-port system, as permanent means for insulin&#xD;
      administration, or as a bridge for future pump management, may be a simple solution in real&#xD;
      life for multiple injections, maintaining glucose in target range and prevention of&#xD;
      post-prandial glycemic excursions.&#xD;
&#xD;
      Aims of study:&#xD;
&#xD;
      To assess the efficacy of I-port use in recent onset T1D in a pediatric population, in&#xD;
      increasing insulin administration and possibly improving time in range of glucose.&#xD;
&#xD;
      To compare the number of daily insulin injections, total daily insulin dose per kg, glycemic&#xD;
      parameters, safety of administration and quality of life between multiple subcutaneous&#xD;
      insulin injections with and without iPORT in children and adolescents with recent -onset type&#xD;
      1 diabetes .&#xD;
&#xD;
      Research template:&#xD;
&#xD;
      A multi-center, open label, randomized controlled clinical trial. Patients will be recruited&#xD;
      during the first 4 weeks of diagnosis, for a study duration of 2 months.&#xD;
&#xD;
      Computerized randomization of patients will be performed to allocate them to the I-port and&#xD;
      control groups, at a 2:1 ratio.&#xD;
&#xD;
      Use of I-port will be demonstrated and inserted for the first time to the I-port group by a&#xD;
      diabetes nurse according to manufacture guidelines Patients will be instructed to administer&#xD;
      insulin prior to each meal or snack according to carbohydrate counting or sliding scale.&#xD;
&#xD;
      Patients will be instructed to always use an insulin cap attached to their insulin pen&#xD;
      Patients will use Libre continuous glucose monitoring system, as per clinical 2019&#xD;
      guidelines, for glucose monitoring Questionnaires regarding quality of life, treatment&#xD;
      satisfaction and degree of pain and discomfort will be filled at end of study All&#xD;
      participants allocated to the control group will have the opportunity to use I-port for 2&#xD;
      months at end of study, with no cost.&#xD;
&#xD;
      All study equipment, including insulin caps and activity tracker will remain at participants&#xD;
      possession at end of study.&#xD;
&#xD;
      Research duration:&#xD;
&#xD;
      The study is anticipated to last approximately 24 months from first investigational center&#xD;
      initiation to finalization of all data entry and monitoring procedures. Subject participation&#xD;
      is expected to be approximately of 60 days.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      The study population will include 35 patients (according to sample size calculation, as&#xD;
      described below) aged 1-18 years with type 1 diabetes&#xD;
&#xD;
      Non-investigational Additional Devices:&#xD;
&#xD;
        1. Abbott Libre Flash Glucose Monitoring&#xD;
           https://www.diabetescare.abbott/worldwide-locations.html&#xD;
&#xD;
        2. Dexcom CGM sensor system https://www.dexcom.com/get-started-cgm/ Both systems are&#xD;
           continuous glucose monitoring systems, used for clinical care according to guidelines&#xD;
           and ministry of health approved devices for T1D management since January 2020 or all&#xD;
           T1DM patients&#xD;
&#xD;
        3. Smart Insulin Pen Cap - Clipsulin™* (Diabnext) to capture by bluetooth connecter all&#xD;
           administered insulin doses including their time and dose, and food if logged in. This is&#xD;
           the only current novel mean available to capture real time accurate insulin&#xD;
           administration by patients. All data will be collected by an app. We will use in this&#xD;
           study a device DiabNext Clipsulin: https://www.diabnext.com/clipsulin-c3/&#xD;
&#xD;
      2. Fitbit™* Fitness Tracker or Apple Watch™* HealthKit™. An activity tracker, which will be&#xD;
      used in order to catch movement according to food, and insulin administration. This is not a&#xD;
      medical device, looks like a watch.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">April 2022</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily insulin administration per day</measure>
    <time_frame>2 years</time_frame>
    <description>The difference in number of insulin administrations per day between I-port and control groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total insulin daily dose per kg per day</measure>
    <time_frame>2 years</time_frame>
    <description>The difference in total daily insulin dose per kg per day between I-port and control groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time in Range difference</measure>
    <time_frame>2 years</time_frame>
    <description>The difference in time in range of glucose per day between I-port and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hyperglycemic and hypoglycemic ranges of glucose per day</measure>
    <time_frame>2 years</time_frame>
    <description>The difference in time in hyperglycemic and hypoglycemic ranges of glucose per day between I-port and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>2 years</time_frame>
    <description>The change in HbA1c from baseline to end of study between I-port and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>coefficient of variability (CV)</measure>
    <time_frame>2 years</time_frame>
    <description>The difference in coefficient of variability (CV) between I-port and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life difference scale 1-46, higher is better</measure>
    <time_frame>2 years</time_frame>
    <description>quality of life difference as measured by PedsQL questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>treatment satisfaction, scale up to 10, higher is better</measure>
    <time_frame>2 years</time_frame>
    <description>treatment satisfaction as measured by DTSQ questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>T1DM</condition>
  <arm_group>
    <arm_group_label>I-Port™*(Medtronic) use Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will administer insulin via iport system. I-Port™* (Medtronic), infusion set, dedicated for insulin deliery for 72 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Insulin Pen Injections</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will administer insulin via injections as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>I-port use</intervention_name>
    <description>patient will use I-port device fo 2 months</description>
    <arm_group_label>I-Port™*(Medtronic) use Arm</arm_group_label>
    <arm_group_label>Insulin Pen Injections</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes within the last 4 weeks&#xD;
&#xD;
          -  Need for insulin injections at least 1 times a day&#xD;
&#xD;
          -  Age of 1-18 years.&#xD;
&#xD;
          -  Agree to comply with all the terms of the study&#xD;
&#xD;
          -  Has an iPhone, iOS 11 or higher OR Android&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin pump therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avital Leshem</last_name>
    <role>Study Director</role>
    <affiliation>Assaf-Harofeh Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marianna Rachmiel, Proff</last_name>
    <phone>+972537346636</phone>
    <email>rmarianna@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Avital Leshem</last_name>
    <phone>+972528303012</phone>
    <email>childendo.research@gmail.com</email>
  </overall_contact_backup>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>May 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04421001
org study id: 0075-20-ASF
nct id: NCT04421001
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Type 1 diabetes is the most common chronic pediatric autoimmune disease, with a rising
      incidence rate in recent years around the world and in Israel Management includes multiple
      daily capillary glucose measurements by finger pricks, or interstitial sugar measurements by
      sensors, and insulin subcutaneous administration before each meal by injections or by an
      insulin pump .

      The initial management and teaching of T1D patients and families includes at least 5-6
      glucose measurements per day and at least 4 insulin injections per day, while the preferred
      guideline should be insulin administration prior to each meal, including morning and
      afternoon snacks, very common among pediatric patients attending school curriculum.

      The early use of I-port at disease diagnosis may reduces pain, increase the amount of daily
      injections, may increase accuracy of insulin administration, and thus improve time in range
      from disease diagnosis.

      Aims of study:

      To assess the efficacy of I-port use in recent onset T1D in a pediatric population, in
      increasing insulin administration and possibly improving time in range of glucose.
Type 1 diabetes is the most common chronic pediatric autoimmune disease, with a rising
      incidence rate in recent years around the world and in Israel Management includes multiple
      daily capillary glucose measurements by finger pricks, or interstitial sugar measurements by
      sensors, and insulin subcutaneous administration before each meal by injections or by an
      insulin pump . Treatment goals include several parameters; keeping glucose levels in target
      range for longer than 70% of the time, having less than 1% of hypoglycemic episodes, and
      maintaining HbA1c less than 7.5%. In the pediatric population, growth parameters, and quality
      of life are of major importance in addition. Studies published worldwide in the past decade
      indicate that only 37% of the diabetic population achieve glycemic control target are
      balanced with the objective of the glycated hemoglobin (HbA1c) below 7.5%, in all suggested
      regimens. One of the major obstacles for achieving target goals is the postprandial
      hyperglycemia. Post prandial hyperglycemia is related to the timing of insulin administration
      and to the amount injected according to carbohydrate content of the meal A significant
      association has been demonstrated between missed insulin boluses prior to meals and glycemic
      control parameters The initial management and teaching of T1D patients and families includes
      at least 5-6 glucose measurements per day and at least 4 insulin injections per day, while
      the preferred guideline should be insulin administration prior to each meal, including
      morning and afternoon snacks, very common among pediatric patients attending school
      curriculum. The reason for those recommendations is based on quality of life consideration,
      increasing adherence to management by less daily painful injections. According to ISPAD
      recommendations, when using injections, it is suggested to consider the use of a device as
      Insuflon (Unomedical) or I-Port (Medtronic) in order to decrease pain, and enable flexibility
      of boluses13.

      The I-Port system (Medtronic) is intended to allow insulin delivery through the port for 72
      hours after port insertion, with one injection, without additional injections or pain. Any
      insulin, including several types of insulin is delivered via the same port by using the
      standard insulin pens. The use of I-port system may solve the obstacle of multiple painful
      daily injections at disease diagnosis, may enable pre-meal administration of insulin before
      meals and snacks, may improve quality of life, and most important, may decrease post prandial
      glucose excursions. Moreover, one should remember that children cannot decide on the amount
      of food prior to meal, and may need for achieving post prandial glucose in range 2 injections
      for each meal, one before and addition after a meal, which is hard to adhere with injections.
      Furthermore, toddlers receive the insulin injections after meals from fear of not finishing
      the meal, thus increasing significantly their post meal glycemic excursion . The early use of
      I-port at disease diagnosis may reduces pain, increase the amount of daily injections, may
      increase accuracy of insulin administration, and thus improve time in range from disease
      diagnosis. Previous report with Insuflon (Unomedical) showed an improvement of 0.7% in HbA1c
      , as well as a low rate of pain, a local response, and no blockage15, but its use is not
      common in the daily life of the patients in light of lack of comfort in insertion, and
      permission to use only one insulin type. The I-port is easier to insert and can be used in
      several types of insulin. The device is effective in adult population, approximately 70% to
      reduce the pain, about 70% improving quality of life and 70% of patients not felt in its
      presence, no change in HbA1c16. Its main side effect is 4% of the reported cases of local
      reactions16.There are no reports in the literature of the use of I-port in the pediatric
      population.

      Technology in T1D has actually provided a solution for those multiple daily injections, by
      using an insulin pump 17. However, insulin pump cannot be used immediately, and not by all
      patients, and is not funded in many countries. Even in developed countries,asIsrael, it takes
      a minimum of 3 months for a patient to start using a pump in real life due to health care
      approvals, financial considerations, technology introduction to families, and education for
      the life with T1D. However, early control of glucose levels and prevention of hyperglycemic
      excursions was proven to prevent short and long term complications, and may lead to better
      long-run glycemic control .

      The hypothesis is that early introduction of an I-port system, as permanent means for insulin
      administration, or as a bridge for future pump management, may be a simple solution in real
      life for multiple injections, maintaining glucose in target range and prevention of
      post-prandial glycemic excursions.

      Aims of study:

      To assess the efficacy of I-port use in recent onset T1D in a pediatric population, in
      increasing insulin administration and possibly improving time in range of glucose.

      To compare the number of daily insulin injections, total daily insulin dose per kg, glycemic
      parameters, safety of administration and quality of life between multiple subcutaneous
      insulin injections with and without iPORT in children and adolescents with recent -onset type
      1 diabetes .

      Research template:

      A multi-center, open label, randomized controlled clinical trial. Patients will be recruited
      during the first 4 weeks of diagnosis, for a study duration of 2 months.

      Computerized randomization of patients will be performed to allocate them to the I-port and
      control groups, at a 2:1 ratio.

      Use of I-port will be demonstrated and inserted for the first time to the I-port group by a
      diabetes nurse according to manufacture guidelines Patients will be instructed to administer
      insulin prior to each meal or snack according to carbohydrate counting or sliding scale.

      Patients will be instructed to always use an insulin cap attached to their insulin pen
      Patients will use Libre continuous glucose monitoring system, as per clinical 2019
      guidelines, for glucose monitoring Questionnaires regarding quality of life, treatment
      satisfaction and degree of pain and discomfort will be filled at end of study All
      participants allocated to the control group will have the opportunity to use I-port for 2
      months at end of study, with no cost.

      All study equipment, including insulin caps and activity tracker will remain at participants
      possession at end of study.

      Research duration:

      The study is anticipated to last approximately 24 months from first investigational center
      initiation to finalization of all data entry and monitoring procedures. Subject participation
      is expected to be approximately of 60 days.

      Study population:

      The study population will include 35 patients (according to sample size calculation, as
      described below) aged 1-18 years with type 1 diabetes

      Non-investigational Additional Devices:

        1. Abbott Libre Flash Glucose Monitoring
           https://www.diabetescare.abbott/worldwide-locations.html

        2. Dexcom CGM sensor system https://www.dexcom.com/get-started-cgm/ Both systems are
           continuous glucose monitoring systems, used for clinical care according to guidelines
           and ministry of health approved devices for T1D management since January 2020 or all
           T1DM patients

        3. Smart Insulin Pen Cap - Clipsulin™* (Diabnext) to capture by bluetooth connecter all
           administered insulin doses including their time and dose, and food if logged in. This is
           the only current novel mean available to capture real time accurate insulin
           administration by patients. All data will be collected by an app. We will use in this
           study a device DiabNext Clipsulin: https://www.diabnext.com/clipsulin-c3/

      2. Fitbit™* Fitness Tracker or Apple Watch™* HealthKit™. An activity tracker, which will be
      used in order to catch movement according to food, and insulin administration. This is not a
      medical device, looks like a watch.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Daily insulin administration per day
time frame: 2 years
description: The difference in number of insulin administrations per day between I-port and control groups
measure: Total insulin daily dose per kg per day
time frame: 2 years
description: The difference in total daily insulin dose per kg per day between I-port and control groups
measure: Time in Range difference
time frame: 2 years
description: The difference in time in range of glucose per day between I-port and control groups
measure: hyperglycemic and hypoglycemic ranges of glucose per day
time frame: 2 years
description: The difference in time in hyperglycemic and hypoglycemic ranges of glucose per day between I-port and control groups
measure: HbA1c
time frame: 2 years
description: The change in HbA1c from baseline to end of study between I-port and control groups
measure: coefficient of variability (CV)
time frame: 2 years
description: The difference in coefficient of variability (CV) between I-port and control groups
measure: quality of life difference scale 1-46, higher is better
time frame: 2 years
description: quality of life difference as measured by PedsQL questionnaire
measure: treatment satisfaction, scale up to 10, higher is better
time frame: 2 years
description: treatment satisfaction as measured by DTSQ questionnaire
arm group label: I-Port™*(Medtronic) use Arm
arm group type: Experimental
description: Patients will administer insulin via iport system. I-Port™* (Medtronic), infusion set, dedicated for insulin deliery for 72 hours.
arm group label: Insulin Pen Injections
arm group type: Active Comparator
description: Patients will administer insulin via injections as usual
intervention type: Device
intervention name: I-port use
description: patient will use I-port device fo 2 months
arm group label: I-Port™*(Medtronic) use Arm
arm group label: Insulin Pen Injections
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Avital Leshem
role: Study Director
affiliation: Assaf-Harofeh Medical Center
last name: Marianna Rachmiel, Proff
phone: +972537346636
email: rmarianna@gmail.com
last name: Avital Leshem
phone: +972528303012
email: childendo.research@gmail.com
responsible party type: Sponsor
sharing ipd: No