<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/NCT03764280</url>
  </required_header>
  <id_info>
    <org_study_id>MDI Optimization Algorithm</org_study_id>
    <nct_id>NCT03764280</nct_id>
  </id_info>
  <brief_title>The Efficacy of MDI Treatment With an Optimization Algorithm Adjusting Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp</brief_title>
  <official_title>An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Efficacy of MDI Treatment With Physician Adjusted and Optimization Algorithm Adjusted Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our lab at McGill University has developed an optimization algorithm for T1D MDI patients&#xD;
      that estimates optimal basal-bolus parameters (basal injections and insulin-to-carbohydrate&#xD;
      ratios) using glucose sensor data and insulin dosing data over several days. The algorithm&#xD;
      examines daily glucose, insulin, and meal data to make changes in patients' basal injections&#xD;
      and ICRs. The investigators hope that this algorithm will be able to optimize the patients'&#xD;
      individual basal injections and ICRs in order to improve glycemic control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this project is to compare our basal-bolus optimization algorithm with&#xD;
      physician adjusted basal-bolus parameters using a randomized parallel clinical trial in&#xD;
      children and adolescents at a Camp Carowanis. The investigators hypothesize that using this&#xD;
      optimization algorithm will be non-inferior to the physician-adjusted basal-bolus parameters&#xD;
      regarding time spent in target glucose range (3.9 mmol/L - 10mmol/L).&#xD;
&#xD;
      Between 40 and 68 children and adolescent type 1 diabetes patients undergoing MDI treatment&#xD;
      at Camp Carowanis will randomly undergo one of two interventions:&#xD;
&#xD;
        1. MDI with Physician Adjusted Basal-Bolus Parameters: Participants will be wearing the&#xD;
           Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their&#xD;
           conventional multiple daily injection (MDI) therapy. At breakfast, the research team&#xD;
           will download the sensor data. Camp physicians will review each participant's sensor and&#xD;
           insulin data and make changes to their parameters based on their clinical judgement, as&#xD;
           they would for all campers, regardless of study participation. These new parameters will&#xD;
           be entered into the patient's camp file.&#xD;
&#xD;
        2. MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters:&#xD;
           Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care).&#xD;
           At breakfast, the data from the glucose sensor and injection information will be entered&#xD;
           into a computer and the optimization algorithm will be run. Camp physicians will review&#xD;
           the algorithm's recommendations before they are entered into the patient's camp file.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2018</start_date>
  <completion_date type="Actual">August 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 10, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>This is an open-label, randomized, two-way, parallel study to compare the glucose control between physician adjusted basal-bolus parameters and our computer basal-bolus optimizing algorithm. Children and adolescent type 1 diabetes patients at Camp Carowanis, a camp for diabetes, will be enrolled in the study, where they will randomly undergo one of two interventions:&#xD;
MDI with Physician Adjusted Basal-Bolus Parameters&#xD;
MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters (OA)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of time of sensor glucose levels spent in target range (defined to be between 3.9 mmol/L and 10.0 mmol/L).</measure>
    <time_frame>the last 7 days of the study.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of time of sensor glucose levels spent:</measure>
    <time_frame>last 7 days of the study</time_frame>
    <description>a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of overnight time (23:00-7:00) of sensor glucose levels</measure>
    <time_frame>last 7 days of the study</time_frame>
    <description>a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of daytime (7:00-23:00) of sensor glucose levels</measure>
    <time_frame>last 7 days of the study</time_frame>
    <description>a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard deviation of glucose levels as a measure of glucose variability</measure>
    <time_frame>last 7 days of the study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total insulin delivery.</measure>
    <time_frame>last 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean sensor glucose level during</measure>
    <time_frame>last 7 days</time_frame>
    <description>a. the overall study period; b. the daytime period; c. overnight period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing hypoglycemia requiring oral treatment during</measure>
    <time_frame>last 7 days</time_frame>
    <description>a. the overall study period; b. the daytime period; c. overnight period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Diabete Mellitus</condition>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>MDI with Physician Adjusted Basal-Bolus Parameters</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MDI with Basal-Bolus Optimization Algorithm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Once daily, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. Once daily, participants' parameters may be changed based on the algorithm's recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multiple Daily Injections: Slow acting insulin and Rapid acting insulin</intervention_name>
    <description>Multiple daily injections (MDI) therapy involves four or more daily insulin injections. Once or twice daily, a long acting insulin is injected as a basal dose. These long acting insulins are designed to dissipate slowly and evenly into the bloodstream for 24 to 36 hours following injection. This basal injection aims to mimic the physiological healthy basal insulin released from a healthy pancreas all day. Furthermore, multiple insulin bolus doses are injected at every meal each day using rapid or short acting insulin. These injections are administered before meals and are calculated using patients' ICRs and meal carbohydrate quantities.</description>
    <arm_group_label>MDI with Basal-Bolus Optimization Algorithm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females between 8 and 18 years old.&#xD;
&#xD;
          2. 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; C peptide level and antibody&#xD;
             determinations are not needed.&#xD;
&#xD;
          3. Undergoing multiple daily injection therapy.&#xD;
&#xD;
          4. HbA1c ≤ 11%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. 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;
          2. Failure to comply with the study protocol or with team's recommendations.&#xD;
&#xD;
          3. Injection of isophane insulin (NPH) or any intermediate-acting insulin&#xD;
&#xD;
          4. More than one injection of slow-acting insulin per day.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Camp Carowanis</name>
      <address>
        <city>Sainte-Agathe-des-Monts</city>
        <state>Quebec</state>
        <zip>J8C 2Z7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Daily Injections</keyword>
  <keyword>type 1 diabetes</keyword>
  <keyword>pediatrics</keyword>
  <keyword>optimization algorithm</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>Insulin</mesh_term>
    <mesh_term>Insulin, Short-Acting</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/NCT03764280
org study id: MDI Optimization Algorithm
nct id: NCT03764280
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Our lab at McGill University has developed an optimization algorithm for T1D MDI patients
      that estimates optimal basal-bolus parameters (basal injections and insulin-to-carbohydrate
      ratios) using glucose sensor data and insulin dosing data over several days. The algorithm
      examines daily glucose, insulin, and meal data to make changes in patients' basal injections
      and ICRs. The investigators hope that this algorithm will be able to optimize the patients'
      individual basal injections and ICRs in order to improve glycemic control.
The objective of this project is to compare our basal-bolus optimization algorithm with
      physician adjusted basal-bolus parameters using a randomized parallel clinical trial in
      children and adolescents at a Camp Carowanis. The investigators hypothesize that using this
      optimization algorithm will be non-inferior to the physician-adjusted basal-bolus parameters
      regarding time spent in target glucose range (3.9 mmol/L - 10mmol/L).

      Between 40 and 68 children and adolescent type 1 diabetes patients undergoing MDI treatment
      at Camp Carowanis will randomly undergo one of two interventions:

        1. MDI with Physician Adjusted Basal-Bolus Parameters: Participants will be wearing the
           Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their
           conventional multiple daily injection (MDI) therapy. At breakfast, the research team
           will download the sensor data. Camp physicians will review each participant's sensor and
           insulin data and make changes to their parameters based on their clinical judgement, as
           they would for all campers, regardless of study participation. These new parameters will
           be entered into the patient's camp file.

        2. MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters:
           Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care).
           At breakfast, the data from the glucose sensor and injection information will be entered
           into a computer and the optimization algorithm will be run. Camp physicians will review
           the algorithm's recommendations before they are entered into the patient's camp file.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is an open-label, randomized, two-way, parallel study to compare the glucose control between physician adjusted basal-bolus parameters and our computer basal-bolus optimizing algorithm. Children and adolescent type 1 diabetes patients at Camp Carowanis, a camp for diabetes, will be enrolled in the study, where they will randomly undergo one of two interventions:
MDI with Physician Adjusted Basal-Bolus Parameters
MDI with Basal-Bolus Optimization Algorithm Adjusted Basal-Bolus Parameters (OA)
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of time of sensor glucose levels spent in target range (defined to be between 3.9 mmol/L and 10.0 mmol/L).
time frame: the last 7 days of the study.
measure: Percentage of time of sensor glucose levels spent:
time frame: last 7 days of the study
description: a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
measure: Percentage of overnight time (23:00-7:00) of sensor glucose levels
time frame: last 7 days of the study
description: a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
measure: Percentage of daytime (7:00-23:00) of sensor glucose levels
time frame: last 7 days of the study
description: a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
measure: Standard deviation of glucose levels as a measure of glucose variability
time frame: last 7 days of the study
measure: Total insulin delivery.
time frame: last 7 days
measure: Mean sensor glucose level during
time frame: last 7 days
description: a. the overall study period; b. the daytime period; c. overnight period.
measure: Number of participants experiencing hypoglycemia requiring oral treatment during
time frame: last 7 days
description: a. the overall study period; b. the daytime period; c. overnight period.
arm group label: MDI with Physician Adjusted Basal-Bolus Parameters
arm group type: No Intervention
description: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy.
arm group label: MDI with Basal-Bolus Optimization Algorithm
arm group type: Experimental
description: Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Once daily, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. Once daily, participants' parameters may be changed based on the algorithm's recommendations.
intervention type: Other
intervention name: Multiple Daily Injections: Slow acting insulin and Rapid acting insulin
description: Multiple daily injections (MDI) therapy involves four or more daily insulin injections. Once or twice daily, a long acting insulin is injected as a basal dose. These long acting insulins are designed to dissipate slowly and evenly into the bloodstream for 24 to 36 hours following injection. This basal injection aims to mimic the physiological healthy basal insulin released from a healthy pancreas all day. Furthermore, multiple insulin bolus doses are injected at every meal each day using rapid or short acting insulin. These injections are administered before meals and are calculated using patients' ICRs and meal carbohydrate quantities.
arm group label: MDI with Basal-Bolus Optimization Algorithm
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Short-Acting