xml: <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/NCT06021158</url>
    </required_header>
    <id_info>
      <org_study_id>2024-9583</org_study_id>
      <nct_id>NCT06021158</nct_id>
    </id_info>
    <brief_title>A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes</brief_title>
    <acronym>Lilly-MEALS</acronym>
    <official_title>A Randomized, Crossover, Pilot Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin&#xD;
        (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated&#xD;
        are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal&#xD;
        detection. The investigators are doing this research to evaluate if carbohydrate counting can&#xD;
        be simplified in patients with type 1 diabetes.&#xD;
  &#xD;
        Participants will test each meal strategy in random order, and each meal strategy will be 21&#xD;
        days long. For the duration of each meal strategy, participants will use an automated insulin&#xD;
        delivery system or &quot;artificial pancreas&quot; with an ultra-rapid insulin called Lyumjev.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>Phase 2</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)</measure>
      <time_frame>14 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of time of glucose levels spent in the following ranges: - between 3.9 and 7.8 mmol/L - below 3.9 mmol/L - below 3.0 mmol/L - above 10.0 mmol/L - above 13.9 mmol/L</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean glucose levels</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Standard deviation of glucose levels</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Standard deviation of insulin delivery</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coefficient of variance of glucose levels</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coefficient of variance of insulin delivery</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total insulin delivery (overall, basal, and bolus)</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after meal insulin boluses</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the sensor glucose concentration-time curve (AUC) from 1-2 hours, 2-3 hours, 3-4 hours, and 4-5 hours after meal insulin boluses</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decremental sensor glucose concentration for the duration of announced exercise periods</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after the end of announced exercise periods</measure>
      <time_frame>14 days</time_frame>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Diabetes Mellitus, Type 1</condition>
    <condition>Type 1 Diabetes</condition>
    <arm_group>
      <arm_group_label>AID-count</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>AID-estimate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>AID-detect</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Hybrid automated Lyumjev delivery system with carbohydrate counting</intervention_name>
      <description>In this system, a Lyumjev insulin bolus is initiated at mealtime based on the total grams of carbohydrates counted. This is the same as commercial hybrid closed-loop insulin therapy (standard treatment).</description>
      <arm_group_label>AID-count</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Hybrid automated Lyumjev delivery system with meal size estimation</intervention_name>
      <description>In this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal).</description>
      <arm_group_label>AID-estimate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Fully automated Lyumjev delivery system with meal detection</intervention_name>
      <description>In this system, the patient does not initiate a Lyumjev insulin bolus at mealtime. An algorithm is used to detect a meal and administer a subsequent bolus, rather than requiring a carbohydrate count.</description>
      <arm_group_label>AID-detect</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1&#xD;
               diabetes is based on the investigator's judgment per local and international guideline&#xD;
               criteria.&#xD;
  &#xD;
            -  Insulin pump use for at least 3 months.&#xD;
  &#xD;
            -  Individuals of childbearing potential must agree to use a highly effective method of&#xD;
               birth control.&#xD;
  &#xD;
            -  Willing to switch to Lyumjev insulin for the duration of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin…);&#xD;
               1 month for GLP1-RA.&#xD;
  &#xD;
            -  Use of glucocorticoids (except low, stable doses and inhaled steroids).&#xD;
  &#xD;
            -  Use of hydroxyurea.&#xD;
  &#xD;
            -  Planned or ongoing pregnancy.&#xD;
  &#xD;
            -  Breastfeeding.&#xD;
  &#xD;
            -  Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the&#xD;
               assistance of another person, due to altered consciousness, to administer&#xD;
               carbohydrates, glucagon, or other resuscitative actions) within one month of&#xD;
               admission.&#xD;
  &#xD;
            -  Clinically significant retinopathy, nephropathy, or neuropathy as judged by the&#xD;
               investigator.&#xD;
  &#xD;
            -  Recent (&lt;6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac&#xD;
               surgery.&#xD;
  &#xD;
            -  Known hypersensitivity to the study drug or its excipients.&#xD;
  &#xD;
            -  Other serious medical illness likely to interfere with study participation or with the&#xD;
               ability to complete the trial, as judged by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Michael Tsoukas, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Royal Victoria Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmad Haidar, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Research Institute of the McGill University University Health Centre</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Laurent Legault, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Montreal Children's Hospital of the MUHC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Melissa-Rosina Pasqua, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Research Institute of the McGill University Health Centre</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carolyne Schumacher</last_name>
      <phone>514-258-5431</phone>
      <email>carolyne.schumacher@mail.mcgill.ca</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
      <investigator_full_name>Michael Tsoukas</investigator_full_name>
      <investigator_title>Associate Professor, Endocrinology &amp; Metabolism</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021158
  org study id: 2024-9583
  nct id: NCT06021158
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin
        (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated
        are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal
        detection. The investigators are doing this research to evaluate if carbohydrate counting can
        be simplified in patients with type 1 diabetes.
  
        Participants will test each meal strategy in random order, and each meal strategy will be 21
        days long. For the duration of each meal strategy, participants will use an automated insulin
        delivery system or "artificial pancreas" with an ultra-rapid insulin called Lyumjev.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)
  time frame: 14 days
  measure: Percentage of time of glucose levels spent in the following ranges: - between 3.9 and 7.8 mmol/L - below 3.9 mmol/L - below 3.0 mmol/L - above 10.0 mmol/L - above 13.9 mmol/L
  time frame: 14 days
  measure: Mean glucose levels
  time frame: 14 days
  measure: Standard deviation of glucose levels
  time frame: 14 days
  measure: Standard deviation of insulin delivery
  time frame: 14 days
  measure: Coefficient of variance of glucose levels
  time frame: 14 days
  measure: Coefficient of variance of insulin delivery
  time frame: 14 days
  measure: Total insulin delivery (overall, basal, and bolus)
  time frame: 14 days
  measure: Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after meal insulin boluses
  time frame: 14 days
  measure: Area under the sensor glucose concentration-time curve (AUC) from 1-2 hours, 2-3 hours, 3-4 hours, and 4-5 hours after meal insulin boluses
  time frame: 14 days
  measure: Decremental sensor glucose concentration for the duration of announced exercise periods
  time frame: 14 days
  measure: Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after the end of announced exercise periods
  time frame: 14 days
  arm group label: AID-count
  arm group type: Active Comparator
  arm group label: AID-estimate
  arm group type: Experimental
  arm group label: AID-detect
  arm group type: Experimental
  intervention type: Combination Product
  intervention name: Hybrid automated Lyumjev delivery system with carbohydrate counting
  description: In this system, a Lyumjev insulin bolus is initiated at mealtime based on the total grams of carbohydrates counted. This is the same as commercial hybrid closed-loop insulin therapy (standard treatment).
  arm group label: AID-count
  intervention type: Combination Product
  intervention name: Hybrid automated Lyumjev delivery system with meal size estimation
  description: In this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal).
  arm group label: AID-estimate
  intervention type: Combination Product
  intervention name: Fully automated Lyumjev delivery system with meal detection
  description: In this system, the patient does not initiate a Lyumjev insulin bolus at mealtime. An algorithm is used to detect a meal and administer a subsequent bolus, rather than requiring a carbohydrate count.
  arm group label: AID-detect
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michael Tsoukas, M.D.
  role: Principal Investigator
  affiliation: Royal Victoria Hospital
  last name: Ahmad Haidar, Ph.D.
  role: Study Chair
  affiliation: Research Institute of the McGill University University Health Centre
  last name: Laurent Legault, M.D.
  role: Study Chair
  affiliation: Montreal Children's Hospital of the MUHC
  last name: Melissa-Rosina Pasqua, M.D.
  role: Study Chair
  affiliation: Research Institute of the McGill University Health Centre
  last name: Carolyne Schumacher
  phone: 514-258-5431
  email: carolyne.schumacher@mail.mcgill.ca
  responsible party type: Principal Investigator
  investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
  investigator full name: Michael Tsoukas
  investigator title: Associate Professor, Endocrinology & Metabolism
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1