<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/NCT02994277</url>
  </required_header>
  <id_info>
    <org_study_id>2680</org_study_id>
    <nct_id>NCT02994277</nct_id>
  </id_info>
  <brief_title>Artificial Pancreas in Latin America</brief_title>
  <official_title>Pilot Study of Automatic Glycaemic Correction Systems (Closed-loop) in Patients With Type 1 Diabetes Mellitus With Continuous Subcutaneous Insulin Infusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Italiano de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Tecnológico de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Nacional de La Plata</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universidad Nacional de Quilmes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundación Nuria/Cellex</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Italiano de Buenos Aires</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to use closed-loop systems with the algorithms designed by the&#xD;
      University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad&#xD;
      Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion&#xD;
      of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims:&#xD;
&#xD;
        1. To test University of Virginia closed-loop algorithm with meal announcement for 36 hours&#xD;
           at our facilities.&#xD;
&#xD;
        2. To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/&#xD;
           Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm&#xD;
           without meal announcement to maintain glucose control for 2 periods of 12 hours&#xD;
&#xD;
      In both cases, the adequate operation of the system will be considered verified if the system&#xD;
      works properly at least 80% of the total connection time .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">July 7, 2017</completion_date>
  <primary_completion_date type="Actual">July 6, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>System connectivity</measure>
    <time_frame>36 hours</time_frame>
    <description>Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical fail rate</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in glycaemia between 70-180 mg/dl</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in glycaemia between 181-250 mg/dl</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in hypoglycaemia defined as &lt;70 mg/dl</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in hyperglycaemia defined as &gt;180 mg/dl</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of all hypoglycaemic events (syntomatic and non syntomatic)</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meal composition's effect in the efficacy of the system to control glycaemia</measure>
    <time_frame>36 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>UVa and ITBA/UNLP algorithm arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm</intervention_name>
    <description>The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.</description>
    <arm_group_label>UVa and ITBA/UNLP algorithm arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient have been diagnosed with T1DM at least two years ago and have been using an&#xD;
             insulin pump and a CGM for at least 6 months prior to the trial first visit.&#xD;
&#xD;
          -  Patient is &gt;18 and &lt;65 years.&#xD;
&#xD;
          -  Patient has HbA1c &gt; 6.5 % and &lt; 10%.&#xD;
&#xD;
          -  Woman in premenopausal age agrees to use contraceptive methods.&#xD;
&#xD;
          -  Woman in premenopausal age has negative B-HCG in the tests performed in the trial.&#xD;
&#xD;
          -  Patient is trained in carbohydrates counting.&#xD;
&#xD;
          -  Patient has signed informed consent and has the ability to understand the nature and&#xD;
             intent of the study including the ability to comply with study procedures and is&#xD;
             willing to keep scheduled visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has been hospitalized for diabetic ketoacidosis in the last 12 months.&#xD;
&#xD;
          -  Patient has experienced severe hypoglycemia with loss of consciousness in the last 12&#xD;
             months.&#xD;
&#xD;
          -  Patient has a history of coronary disease or cardiac failure.&#xD;
&#xD;
          -  Patient with uncontrolled arterial hypertension.&#xD;
&#xD;
          -  Patient with a condition that makes the researcher believe that it might increase the&#xD;
             chance of hypoglycemia.&#xD;
&#xD;
          -  Patient has symptoms compatible with an active infectious disease.&#xD;
&#xD;
          -  Patient has Cystic Fibrosis.&#xD;
&#xD;
          -  Pregnant women, or women with the intention of getting pregnant; women breastfeeding.&#xD;
&#xD;
          -  Patient has been hospitalized for psychiatric treatment in the last 6 months.&#xD;
&#xD;
          -  Patient with a diagnosis of an adrenal disease.&#xD;
&#xD;
          -  Patient has abnormal laboratory values for liver function: transaminase &gt; 2x upper&#xD;
             limit of normal.&#xD;
&#xD;
          -  Patient has abnormal laboratory values for renal function: GFR &lt; 60 ml/min/1.73m2&#xD;
&#xD;
          -  Patient has active gastroparesis.&#xD;
&#xD;
          -  Patient is under oncological treatment.&#xD;
&#xD;
          -  Patient has taken acetaminophen 72 hours previous to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Waldo H Belloso, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Italiano de Buenos Aires</affiliation>
  </overall_official>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>November 7, 2017</last_update_submitted>
  <last_update_submitted_qc>November 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>&quot;Artificial Pancreas&quot;</keyword>
  <keyword>&quot;control System&quot;</keyword>
  <keyword>&quot;Closed loop&quot;</keyword>
  <keyword>diabetes</keyword>
  <keyword>&quot;T1DM&quot;</keyword>
  <keyword>&quot;pump&quot;</keyword>
  <keyword>algorithm</keyword>
  <keyword>CGM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT02994277
org study id: 2680
nct id: NCT02994277
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to use closed-loop systems with the algorithms designed by the
      University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad
      Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion
      of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).
Aims:

        1. To test University of Virginia closed-loop algorithm with meal announcement for 36 hours
           at our facilities.

        2. To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/
           Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm
           without meal announcement to maintain glucose control for 2 periods of 12 hours

      In both cases, the adequate operation of the system will be considered verified if the system
      works properly at least 80% of the total connection time .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: System connectivity
time frame: 36 hours
description: Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time.
measure: Technical fail rate
time frame: 36 hours
measure: Percentage of time in glycaemia between 70-180 mg/dl
time frame: 36 hours
measure: Percentage of time in glycaemia between 181-250 mg/dl
time frame: 36 hours
measure: Percentage of time in hypoglycaemia defined as <70 mg/dl
time frame: 36 hours
measure: Percentage of time in hyperglycaemia defined as >180 mg/dl
time frame: 36 hours
measure: Number of all hypoglycaemic events (syntomatic and non syntomatic)
time frame: 36 hours
measure: Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial
time frame: 36 hours
measure: Meal composition's effect in the efficacy of the system to control glycaemia
time frame: 36 hours
arm group label: UVa and ITBA/UNLP algorithm arm
arm group type: Experimental
description: To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm
intervention type: Device
intervention name: 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm
description: The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.
arm group label: UVa and ITBA/UNLP algorithm arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Waldo H Belloso, MD
role: Study Director
affiliation: Hospital Italiano de Buenos Aires
responsible party type: Sponsor
mesh term: Diabetes Mellitus
sharing ipd: No