<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/NCT02987556</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01198-43</org_study_id>
    <nct_id>NCT02987556</nct_id>
  </id_info>
  <brief_title>Diabeloop WP7 : Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop (WP7)</brief_title>
  <acronym>WP7</acronym>
  <official_title>Crossover Evaluation of the Safety and the Efficacy of Artificial Pancreas Diabeloop for Three Months at Home in Comparison With Conventional Treatment by External Insulin Pump in Patients With Type 1 Diabetes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète</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>
      The study will be conducted in crossover trial, with two 12-weeks periods separated by a&#xD;
      Wash-out period of at least one month. According to randomization ,patients will be provided&#xD;
      with either Diabeloop system or the usual system.&#xD;
&#xD;
      Patients will be trained for the use of blood glucose meter, of external Insulin Pump and&#xD;
      Diabeloop system.&#xD;
&#xD;
      In both treatment periods, the same blood glucose meter will be used throughout the duration&#xD;
      of the study.&#xD;
&#xD;
      In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be&#xD;
      performed during four weeks to improve the efficacy of Diabeloop system with data collection,&#xD;
      to test the manual settings by health care providers and patients and to check the&#xD;
      good-working of the follow-up platform.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Actual">August 28, 2018</completion_date>
  <primary_completion_date type="Actual">August 28, 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>
    <intervention_model_description>Closed loop vs. Open loop,</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks</measure>
    <time_frame>For 12 weeks</time_frame>
    <description>measurement of glucose by CGM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose &gt;180 mg/dL during nights and during 24 hours for 12 weeks</measure>
    <time_frame>During 24 hours for 12 weeks</time_frame>
    <description>measurement of glucose by CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of HbA1c at the onset and at the end of each period of treatment</measure>
    <time_frame>During 12 weeks for each period of treatment</time_frame>
    <description>Dosage of HbA1c every 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average blood glucose levels throughout the full period</measure>
    <time_frame>During 12 weeks for each period of treatment</time_frame>
    <description>measurement of glucose by CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks</measure>
    <time_frame>Throughout the full period during 12 weeks</time_frame>
    <description>measurement of glucose by CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total supplies of insulin during tests</measure>
    <time_frame>During 12 weeks for each period</time_frame>
    <description>total basal and bolus by 24h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hyper-glycemic events defined by American Diabetes Association (ADA) : severe hyperglycemia &gt; 360 mg/dl (20 mmol/l) measured by CGM or significant ketose (acetonemia &gt; 3 mmol/l)</measure>
    <time_frame>During 12 weeks for each period</time_frame>
    <description>measurement of glucose by CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycemic events, defined by any threshold crossing 60 mg/dl ( 3,33 mmol/l); 70 mg/dl (3,9 mmol/l) and &lt; 54 mg/dl (3 mmol/l) measured by the CGM</measure>
    <time_frame>During 12 weeks for each period</time_frame>
    <description>measurement of glucose by CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring the oral carbohydrates intake during the last week of each period of treatment</measure>
    <time_frame>During 24 hours for one week before the end of each period of treatment</time_frame>
    <description>data collected on a booklet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of technical problems causing interruptions of the closed loop</measure>
    <time_frame>During 12 weeks for the closed loop period</time_frame>
    <description>technical incidents data collected during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time spent in good-working mode during the closed loop period</measure>
    <time_frame>During 12 weeks for the closed loop period</time_frame>
    <description>measurement of glucose by CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia</measure>
    <time_frame>During 12 weeks at the end of each period of treatment</time_frame>
    <description>DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time spent in blood glucose &lt;70 mg/dl continuously measured for 12 weeks</measure>
    <time_frame>For 12 weeks</time_frame>
    <description>measurement of glucose by CGM</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Closed Loop</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Usual System (open-loop)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DIABELOOP System (closed-loop)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitoring</intervention_name>
    <description>Collection of glucose data</description>
    <arm_group_label>DIABELOOP System (closed-loop)</arm_group_label>
    <arm_group_label>Usual System (open-loop)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>External Insulin Pump</intervention_name>
    <description>insulin delivery</description>
    <arm_group_label>DIABELOOP System (closed-loop)</arm_group_label>
    <arm_group_label>Usual System (open-loop)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>telemdecine</intervention_name>
    <description>Remote follow up by care health providers team</description>
    <arm_group_label>DIABELOOP System (closed-loop)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The Diabeloop Software (Model predictive control)</intervention_name>
    <description>Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.</description>
    <arm_group_label>DIABELOOP System (closed-loop)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetic patient for at least two years&#xD;
&#xD;
          -  Patient treated by external insulin pump for at least 6 months&#xD;
&#xD;
          -  Patient with HbA1c ≤ 10%; dosage of less than 4 months done in analysis laboratory&#xD;
             medical or equivalent.&#xD;
&#xD;
          -  Patient requiring a daily dose of insulin ≤ 50 units&#xD;
&#xD;
          -  Patient domiciled in an area with Global System for Mobile Communication (GSM)&#xD;
&#xD;
          -  Not isolated patient, not living alone, or having a person &quot;resource&quot; living nearby&#xD;
             and having a phone and the key of its place of residence&#xD;
&#xD;
          -  Patient not envisaging a journey outside France during the &quot;closed-loop&quot; period&#xD;
&#xD;
          -  Patient aged over 18 years&#xD;
&#xD;
          -  Patient affiliated to Social Security&#xD;
&#xD;
          -  Patient who agreed to participate in the study and who signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with any serious illness that may impair study participation&#xD;
&#xD;
          -  Patient having a treatment known to have a significant interference on the glycemia.&#xD;
&#xD;
          -  Patient enjoying a measure of legal protection&#xD;
&#xD;
          -  Pregnant woman or likely to be&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Sud-Francilien</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Grenoble</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Marseille</city>
        <zip>13000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Reims</city>
        <zip>51100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire</name>
      <address>
        <city>Toulouse</city>
        <zip>31400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</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>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/NCT02987556
org study id: 2016-A01198-43
nct id: NCT02987556
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will be conducted in crossover trial, with two 12-weeks periods separated by a
      Wash-out period of at least one month. According to randomization ,patients will be provided
      with either Diabeloop system or the usual system.

      Patients will be trained for the use of blood glucose meter, of external Insulin Pump and
      Diabeloop system.

      In both treatment periods, the same blood glucose meter will be used throughout the duration
      of the study.

      In two centers (Centre Hospitalier Sud-Francilien and Grenoble), a pre-study will be
      performed during four weeks to improve the efficacy of Diabeloop system with data collection,
      to test the manual settings by health care providers and patients and to check the
      good-working of the follow-up platform.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Closed loop vs. Open loop,
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of time spent in the tight glycemic control area 70-180 mg/dl continuously measured for 12 weeks
time frame: For 12 weeks
description: measurement of glucose by CGM
measure: Percentage of time spent in the glycemic range 70-180 mg/dl, 80-140 mg/dl and in blood glucose >180 mg/dL during nights and during 24 hours for 12 weeks
time frame: During 24 hours for 12 weeks
description: measurement of glucose by CGM
measure: Measurement of HbA1c at the onset and at the end of each period of treatment
time frame: During 12 weeks for each period of treatment
description: Dosage of HbA1c every 3 months
measure: Average blood glucose levels throughout the full period
time frame: During 12 weeks for each period of treatment
description: measurement of glucose by CGM
measure: Calculated risks of hypo- and hyperglycemia (LBGI, HBGI) throughout the full period during 12 weeks
time frame: Throughout the full period during 12 weeks
description: measurement of glucose by CGM
measure: Total supplies of insulin during tests
time frame: During 12 weeks for each period
description: total basal and bolus by 24h
measure: Number of hyper-glycemic events defined by American Diabetes Association (ADA) : severe hyperglycemia > 360 mg/dl (20 mmol/l) measured by CGM or significant ketose (acetonemia > 3 mmol/l)
time frame: During 12 weeks for each period
description: measurement of glucose by CGM
measure: Number of hypoglycemic events, defined by any threshold crossing 60 mg/dl ( 3,33 mmol/l); 70 mg/dl (3,9 mmol/l) and < 54 mg/dl (3 mmol/l) measured by the CGM
time frame: During 12 weeks for each period
description: measurement of glucose by CGM
measure: Measuring the oral carbohydrates intake during the last week of each period of treatment
time frame: During 24 hours for one week before the end of each period of treatment
description: data collected on a booklet
measure: Number of technical problems causing interruptions of the closed loop
time frame: During 12 weeks for the closed loop period
description: technical incidents data collected during the study
measure: Percentage of time spent in good-working mode during the closed loop period
time frame: During 12 weeks for the closed loop period
description: measurement of glucose by CGM
measure: For the use and the acceptance, a satisfaction survey will be done on the daily management of diabetes, the modification of daily life with the system dan the fear of hypoglycemia
time frame: During 12 weeks at the end of each period of treatment
description: DTSQ satisfaction questionnaire, with scale from 6 to 0 where 0 is the worth and 6 the best outcome.
measure: Percentage of time spent in blood glucose <70 mg/dl continuously measured for 12 weeks
time frame: For 12 weeks
description: measurement of glucose by CGM
arm group label: Usual System (open-loop)
arm group type: Active Comparator
description: In open loop, patients will be provided with an Continuous Glucose Monitoring (CGM) and an external insulin pump programmed with its usual treatment previously prescribed by its physician.
arm group label: DIABELOOP System (closed-loop)
arm group type: Experimental
description: In the closed-loop, patients will be provided with the Diabeloop system consisting of insulin pump Cellnovo or Kaleido driven by remote control augmented by Diabeloop software and connected to the CGM Prescription of insulin doses proposed by a predictive algorithm.
intervention type: Device
intervention name: Continuous Glucose Monitoring
description: Collection of glucose data
arm group label: DIABELOOP System (closed-loop)
arm group label: Usual System (open-loop)
intervention type: Device
intervention name: External Insulin Pump
description: insulin delivery
arm group label: DIABELOOP System (closed-loop)
arm group label: Usual System (open-loop)
intervention type: Other
intervention name: telemdecine
description: Remote follow up by care health providers team
arm group label: DIABELOOP System (closed-loop)
intervention type: Device
intervention name: The Diabeloop Software (Model predictive control)
description: Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.
arm group label: DIABELOOP System (closed-loop)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
sharing ipd: No