<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/NCT03300934</url>
  </required_header>
  <id_info>
    <org_study_id>Spidiman</org_study_id>
    <nct_id>NCT03300934</nct_id>
  </id_info>
  <brief_title>Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?</brief_title>
  <acronym>SPIDIMAN2</acronym>
  <official_title>Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier du Luxembourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cambridge</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Luxembourg Institute of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier du Luxembourg</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>
      This study evaluates the use of the FD2 automated closed loop insulin administration in&#xD;
      Adolescents with a poor metabolic control . All youth will be treated in a random order by&#xD;
      their usual pump treatment or an Automated system and we will evaluate whether this has an&#xD;
      impact on metabolic control and sleep&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Achievement of a good metabolic control is very important for all persons with diabetes . In&#xD;
      adolescence many changes occur , physically , socially and psychologically .This may&#xD;
      influence the metabolic control . This study will evaluate whether the automated closed-loop&#xD;
      will facilitate and improve the management of diabetes in youth with a poor metabolic&#xD;
      control.&#xD;
&#xD;
      It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety&#xD;
      and acceptability of the automated closed-loop glucose control (CL) day and night, over 28&#xD;
      days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting&#xD;
      in poorly controlled type 1 diabetes adolescents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">July 19, 2018</completion_date>
  <primary_completion_date type="Actual">July 19, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time spent in glucose target (%) (3.9 - 10 mmol/l)</measure>
    <time_frame>4 week treatment arms</time_frame>
    <description>Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time spent below glucose target (%) (&lt;3.0mmol/l and &lt; 2,5 mmol/l)</measure>
    <time_frame>4 week treatment arms</time_frame>
    <description>Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent above glucose target (%) (&gt; 10 mmol/l)</measure>
    <time_frame>4 week treatment arms</time_frame>
    <description>Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe hypoglycaemic events</measure>
    <time_frame>4 week treatment arms</time_frame>
    <description>ISPAD Definition of severe hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe Diabetes ketoacidosis</measure>
    <time_frame>4 week treatment arms</time_frame>
    <description>ISPAD definition of severe DKA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of the automated closed loop system (% time)</measure>
    <time_frame>4 week treatment arm</time_frame>
    <description>% time , the system is used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of the CGM during closed loop</measure>
    <time_frame>4 week treatment arm</time_frame>
    <description>% time , the system is used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life perception in adolescents</measure>
    <time_frame>4 week treatment periods</time_frame>
    <description>Questionnaire based</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Responsibility perception</measure>
    <time_frame>4 week treatment periods</time_frame>
    <description>Questionnaire based : Family responsibility scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User experience after the 4 week treatment</measure>
    <time_frame>4 week intervention</time_frame>
    <description>questionnaire based</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Type1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>closed loop glucose control system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Closed loop glucose control system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSII Pump treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>CSII Pump treatment without the integrated algorithm and glucose sensor</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>closed loop glucose control system</intervention_name>
    <description>Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment</description>
    <arm_group_label>closed loop glucose control system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment&#xD;
        for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient&#xD;
        and parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non-type 1 diabetes mellitus including those secondary to chronic disease Any other&#xD;
        physical or psychological disease or condition likely to interfere with the normal conduct&#xD;
        of the study and interpretation of the study results as judged by the investigator.&#xD;
&#xD;
        Current treatment with drugs known to have significant interference with glucose&#xD;
        metabolism, such as systemic corticosteroids, as judged by the investigator Known or&#xD;
        suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by&#xD;
        ISPAD guidelines during the previous 12 months.&#xD;
&#xD;
        More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12&#xD;
        months&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carine de Beaufort, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier du Luxembourg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique des Enfants CHluxembourg</name>
      <address>
        <city>Luxembourg</city>
        <zip>1210</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Luxembourg</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>July 29, 2018</last_update_submitted>
  <last_update_submitted_qc>July 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier du Luxembourg</investigator_affiliation>
    <investigator_full_name>Carine de Beaufort</investigator_full_name>
    <investigator_title>Guest professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <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/NCT03300934
org study id: Spidiman
nct id: NCT03300934
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the use of the FD2 automated closed loop insulin administration in
      Adolescents with a poor metabolic control . All youth will be treated in a random order by
      their usual pump treatment or an Automated system and we will evaluate whether this has an
      impact on metabolic control and sleep
Achievement of a good metabolic control is very important for all persons with diabetes . In
      adolescence many changes occur , physically , socially and psychologically .This may
      influence the metabolic control . This study will evaluate whether the automated closed-loop
      will facilitate and improve the management of diabetes in youth with a poor metabolic
      control.

      It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety
      and acceptability of the automated closed-loop glucose control (CL) day and night, over 28
      days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting
      in poorly controlled type 1 diabetes adolescents.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time spent in glucose target (%) (3.9 - 10 mmol/l)
time frame: 4 week treatment arms
description: Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.
measure: Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)
time frame: 4 week treatment arms
description: Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)
measure: Time spent above glucose target (%) (> 10 mmol/l)
time frame: 4 week treatment arms
description: Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)
measure: Severe hypoglycaemic events
time frame: 4 week treatment arms
description: ISPAD Definition of severe hypoglycemia
measure: Severe Diabetes ketoacidosis
time frame: 4 week treatment arms
description: ISPAD definition of severe DKA
measure: Use of the automated closed loop system (% time)
time frame: 4 week treatment arm
description: % time , the system is used
measure: Use of the CGM during closed loop
time frame: 4 week treatment arm
description: % time , the system is used
measure: Quality of life perception in adolescents
time frame: 4 week treatment periods
description: Questionnaire based
measure: Family Responsibility perception
time frame: 4 week treatment periods
description: Questionnaire based : Family responsibility scale
measure: User experience after the 4 week treatment
time frame: 4 week intervention
description: questionnaire based
arm group label: closed loop glucose control system
arm group type: Experimental
description: Closed loop glucose control system
arm group label: CSII Pump treatment
arm group type: No Intervention
description: CSII Pump treatment without the integrated algorithm and glucose sensor
intervention type: Device
intervention name: closed loop glucose control system
description: Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment
arm group label: closed loop glucose control system
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Carine de Beaufort, MD PhD
role: Principal Investigator
affiliation: Centre Hospitalier du Luxembourg
facility: 
country: Luxembourg
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier du Luxembourg
investigator full name: Carine de Beaufort
investigator title: Guest professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No