<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/NCT02189694</url>
  </required_header>
  <id_info>
    <org_study_id>CLASS-08</org_study_id>
    <nct_id>NCT02189694</nct_id>
  </id_info>
  <brief_title>Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp</brief_title>
  <official_title>An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Overnight Glucose Levels in Children With Type 1 Diabetes in a Diabetes Camp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherches Cliniques de Montreal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Montreal Children's Hospital of the MUHC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut de Recherches Cliniques de Montreal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,&#xD;
      insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required&#xD;
      insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would&#xD;
      regulate glucose levels through the infusion of two hormone: insulin and glucagon.&#xD;
&#xD;
      The main objective of this project is to compare the efficacy of single-hormone closed-loop&#xD;
      strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose&#xD;
      levels in children with type 1 diabetes in a diabetes camp.&#xD;
&#xD;
      The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent&#xD;
      in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop&#xD;
      strategy, which in turn is more effective than the conventional pump therapy to reduce time&#xD;
      spent in hypoglycemia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,&#xD;
      insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required&#xD;
      insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would&#xD;
      regulate glucose levels through the infusion of two hormone: insulin and glucagon.&#xD;
&#xD;
      The investigators aim to conduct a randomized three-way cross-over trial comparing single&#xD;
      hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump&#xD;
      therapy. The investigators aim to compare the three interventions for 3 consecutive nights in&#xD;
      children with type 1 diabetes in a diabetes camp.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of time of glucose levels spent below 4.0 mmol/L.</measure>
    <time_frame>Up to 8 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of glucose levels spent below 3.5 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of glucose levels spent below 3.3 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of glucose levels spent above 8 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of glucose levels spent above 10 mmol/L.</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose levels below 4.0 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose levels below 3.5 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose levels below 3.3 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose levels above 8.0 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of glucose levels above 10.0 mmol/L.</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean glucose levels.</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard deviation of glucose levels</measure>
    <time_frame>Up to 8 hours</time_frame>
    <description>Measure of glucose variability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total insulin delivery</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemic risk assessed by the total number of hypoglycemic event (&gt; 15 minutes) below 3.1 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (&gt; 15 minutes) below 3.1 mmol/L</measure>
    <time_frame>Up to 8 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Insulin pump therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glucose levels will be controlled for 3 consecutive nights using insulin pump therapy. Subjects will carry on with their normal conventional insulin pump therapy and will be allowed to freely implement therapeutic adjustments..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single-hormone closed-loop strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glucose levels will be controlled by single-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by single-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pump's parameters will then be changed manually to implement the computer generated recommendations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual-hormone closed-loop strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Glucose levels will be controlled by dual-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by dual-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor readings will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses. Pumps' parameters will then be changed manually to implement the computer generated recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Single-hormone closed-loop strategy</intervention_name>
    <description>Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.</description>
    <arm_group_label>Single-hormone closed-loop strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dual-hormone closed-loop strategy</intervention_name>
    <description>Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.</description>
    <arm_group_label>Dual-hormone closed-loop strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insulin pump therapy</intervention_name>
    <description>Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.</description>
    <arm_group_label>Insulin pump therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females between the 8 and 17 years of old.&#xD;
&#xD;
          -  Clinical diagnosis of type 1 diabetes for at least one year. The subject will have&#xD;
             been on insulin pump therapy for at least 3 months.&#xD;
&#xD;
          -  HbA1c ≤ 11.0%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant nephropathy, neuropathy or retinopathy as judged by the&#xD;
             investigator.&#xD;
&#xD;
          -  Severe hypoglycemic episode within two weeks of inclusion in the study. A severe&#xD;
             hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency&#xD;
             visit.&#xD;
&#xD;
          -  Current use of oral glucocorticoid medication (except low stable dose according to&#xD;
             investigator judgement). Stable doses of inhaled steroids are acceptable.&#xD;
&#xD;
          -  Known or suspected allergy to the trial products.&#xD;
&#xD;
          -  Other serious medical illness likely to interfere with study participation or with the&#xD;
             ability to complete the trial by the judgment of the investigator.&#xD;
&#xD;
          -  Failure to comply with team's recommendations (e.g. not willing to use trial pump,&#xD;
             etc).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rémi Rabasa-Lhoret, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de recherches cliniques de Montréal</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de recherches cliniques de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2W 1R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut de Recherches Cliniques de Montreal</investigator_affiliation>
    <investigator_full_name>Rémi Rabasa-Lhoret</investigator_full_name>
    <investigator_title>Associate professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Type 1 diabetes</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Insulin</keyword>
  <keyword>Glucagon</keyword>
  <keyword>Closed-loop system</keyword>
  <keyword>Artificial pancreas</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02189694
org study id: CLASS-08
nct id: NCT02189694
lead sponsor: 
collaborator: 
has dmc: No
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,
      insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required
      insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would
      regulate glucose levels through the infusion of two hormone: insulin and glucagon.

      The main objective of this project is to compare the efficacy of single-hormone closed-loop
      strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose
      levels in children with type 1 diabetes in a diabetes camp.

      The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent
      in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop
      strategy, which in turn is more effective than the conventional pump therapy to reduce time
      spent in hypoglycemia
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels,
      insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required
      insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would
      regulate glucose levels through the infusion of two hormone: insulin and glucagon.

      The investigators aim to conduct a randomized three-way cross-over trial comparing single
      hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump
      therapy. The investigators aim to compare the three interventions for 3 consecutive nights in
      children with type 1 diabetes in a diabetes camp.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of time of glucose levels spent below 4.0 mmol/L.
time frame: Up to 8 hours
measure: Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L
time frame: Up to 8 hours
measure: Percentage of time of glucose levels spent below 3.5 mmol/L
time frame: Up to 8 hours
measure: Percentage of time of glucose levels spent below 3.3 mmol/L
time frame: Up to 8 hours
measure: Percentage of time of glucose levels spent above 8 mmol/L
time frame: Up to 8 hours
measure: Percentage of time of glucose levels spent above 10 mmol/L.
time frame: Up to 8 hours
measure: Area under the curve of glucose levels below 4.0 mmol/L
time frame: Up to 8 hours
measure: Area under the curve of glucose levels below 3.5 mmol/L
time frame: Up to 8 hours
measure: Area under the curve of glucose levels below 3.3 mmol/L
time frame: Up to 8 hours
measure: Area under the curve of glucose levels above 8.0 mmol/L
time frame: Up to 8 hours
measure: Area under the curve of glucose levels above 10.0 mmol/L.
time frame: Up to 8 hours
measure: Mean glucose levels.
time frame: Up to 8 hours
measure: Standard deviation of glucose levels
time frame: Up to 8 hours
description: Measure of glucose variability.
measure: Total insulin delivery
time frame: Up to 8 hours
measure: Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L
time frame: Up to 8 hours
measure: Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L
time frame: Up to 8 hours
arm group label: Insulin pump therapy
arm group type: Active Comparator
description: Glucose levels will be controlled for 3 consecutive nights using insulin pump therapy. Subjects will carry on with their normal conventional insulin pump therapy and will be allowed to freely implement therapeutic adjustments..
arm group label: Single-hormone closed-loop strategy
arm group type: Active Comparator
description: Glucose levels will be controlled by single-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by single-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pump's parameters will then be changed manually to implement the computer generated recommendations.
arm group label: Dual-hormone closed-loop strategy
arm group type: Active Comparator
description: Glucose levels will be controlled by dual-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by dual-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor readings will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses. Pumps' parameters will then be changed manually to implement the computer generated recommendations.
intervention type: Device
intervention name: Single-hormone closed-loop strategy
description: Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
arm group label: Single-hormone closed-loop strategy
intervention type: Device
intervention name: Dual-hormone closed-loop strategy
description: Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.
arm group label: Dual-hormone closed-loop strategy
intervention type: Device
intervention name: Insulin pump therapy
description: Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
arm group label: Insulin pump therapy
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Rémi Rabasa-Lhoret, MD, PhD
role: Principal Investigator
affiliation: Institut de recherches cliniques de Montréal
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Institut de Recherches Cliniques de Montreal
investigator full name: Rémi Rabasa-Lhoret
investigator title: Associate professor of Medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hormones