<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/NCT03804983</url>
  </required_header>
  <id_info>
    <org_study_id>180030</org_study_id>
    <nct_id>NCT03804983</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin</brief_title>
  <official_title>Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tandem Diabetes Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this proposed study is to assess the use of a new feature of the Control-IQ&#xD;
      system, MyTDI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin&#xD;
      parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with&#xD;
      Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1&#xD;
      diabetes.&#xD;
&#xD;
      Once deemed eligible, participants and their parent(s) will be trained on the use of the&#xD;
      Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system.&#xD;
      Participants will then use the this study equipment with their home insulin parameters at&#xD;
      home for at home for 5 days. Participants will then come to the ski resort to participate in&#xD;
      a 72-hour ski admission. Upon arrival, each participant will be randomized to either the&#xD;
      using the Control-IQ system with their usual insulin parameters during the ski study and the&#xD;
      at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and&#xD;
      the at-home 5 days at home study. Study duration for each participant will require 5 study&#xD;
      visits over about 2 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">February 16, 2019</completion_date>
  <primary_completion_date type="Actual">February 16, 2019</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 trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change between Percent Time in Range at home pre/post intervention at home</measure>
    <time_frame>5 days</time_frame>
    <description>The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in average CGM at home</measure>
    <time_frame>5 days</time_frame>
    <description>number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.&#xD;
Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in average CGM at camp</measure>
    <time_frame>2 days</time_frame>
    <description>number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.&#xD;
Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM below 50mg/dL at home</measure>
    <time_frame>5 days</time_frame>
    <description>the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM below 50mg/dL at camp</measure>
    <time_frame>5 days</time_frame>
    <description>the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM below 54mg/dL at camp</measure>
    <time_frame>2 days</time_frame>
    <description>the number of CGM values falling below 54mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent below 60mg/dL at home</measure>
    <time_frame>5 days</time_frame>
    <description>the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent below 60mg/dL at camp</measure>
    <time_frame>2 days</time_frame>
    <description>the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM below 70mg/dL at home</measure>
    <time_frame>5 days</time_frame>
    <description>the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM below 70mg/dL at camp</measure>
    <time_frame>2 days</time_frame>
    <description>the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM between 70mg/dL and 180mg/dL at camp</measure>
    <time_frame>2 days</time_frame>
    <description>the number of CGM values falling between 70mg/dL and 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM above 180mg/dL at home</measure>
    <time_frame>5 days</time_frame>
    <description>the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM above 180mg/dL at camp</measure>
    <time_frame>2 days</time_frame>
    <description>the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM above 250mg/dL at home</measure>
    <time_frame>5 days</time_frame>
    <description>the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM above 250mg/dL at camp</measure>
    <time_frame>5 days2</time_frame>
    <description>the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM above 300mg/dL at home</measure>
    <time_frame>5 days</time_frame>
    <description>the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Percent CGM above 300mg/dL at camp</measure>
    <time_frame>2 days</time_frame>
    <description>the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total daily insulin at home</measure>
    <time_frame>5 days</time_frame>
    <description>sum of the recorded insulin injection over the time frame in units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total daily insulin at camp</measure>
    <time_frame>2 days</time_frame>
    <description>sum of the recorded insulin injection over the time frame in units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total meal carbohydrates at home</measure>
    <time_frame>5 days</time_frame>
    <description>sum of the meal sized recorded over the time frame</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total meal carbohydrates at camp</measure>
    <time_frame>2 days</time_frame>
    <description>sum of the meal sized recorded over the time frame</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of hypoglycemic events at home</measure>
    <time_frame>5 days</time_frame>
    <description>Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Number of hypoglycemic events at camp</measure>
    <time_frame>2 days</time_frame>
    <description>Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of Hypoglycemia treatment at home</measure>
    <time_frame>5 days</time_frame>
    <description>Sum of the number of CHO treatments recorded over the time frame</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of Hypoglycemia treatment at camp</measure>
    <time_frame>2 days</time_frame>
    <description>Sum of the number of CHO treatments recorded over the time frame</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at home</measure>
    <time_frame>5 days</time_frame>
    <description>Sum of the amount of carbohydrates used for treatments recorded over the time frame</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at camp</measure>
    <time_frame>2 days</time_frame>
    <description>Sum of the amount of carbohydrates used for treatments recorded over the time frame</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Hybrid Closed Loop (HCL)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control-IQ with MyTDI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:&#xD;
A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day&#xD;
A single correction factor (CF) of 1650/TDI will be implemented across the whole day&#xD;
Carbohydrate ratios (CR) will be set at:&#xD;
00:00-04:00 CR=450/TDI&#xD;
04:00-11:00 CR=360/TDI&#xD;
11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hybrid Closed Loop (HCL)</intervention_name>
    <description>Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.</description>
    <arm_group_label>Hybrid Closed Loop (HCL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control-IQ with MyTDI</intervention_name>
    <description>Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.</description>
    <arm_group_label>Control-IQ with MyTDI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Criteria for documented hyperglycemia (at least 1 must be met):&#xD;
&#xD;
               -  Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody&#xD;
                  determinations are not required)&#xD;
&#xD;
               -  Diagnosis of type 1 diabetes is based on the investigator's judgement&#xD;
&#xD;
          -  Criteria for requiring insulin at diagnosis (both criteria must be met):&#xD;
&#xD;
               -  Daily insulin therapy for ≥ 6 months&#xD;
&#xD;
               -  Insulin pump therapy for ≥ 3 months&#xD;
&#xD;
          -  Age 12-18 years&#xD;
&#xD;
          -  Currently using no insulins other than one of the following rapid-acting insulins at&#xD;
             the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin&#xD;
             glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or&#xD;
             aspart.&#xD;
&#xD;
          -  Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists,&#xD;
             Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and&#xD;
             naturaceuticals) is permitted if stable on current dose for at least 1 month.&#xD;
&#xD;
          -  Willingness to wear a continuous glucose sensor and physiological monitor for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  For females, not pregnant or breastfeeding. Female subjects who are sexually active&#xD;
             should agree to use birth control during the study.&#xD;
&#xD;
          -  Total daily insulin dose (TDD) at least 10 U/day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetic ketoacidosis in the past 6 months&#xD;
&#xD;
          -  Hypoglycemic seizure or loss of consciousness in the past 6 months&#xD;
&#xD;
          -  History of seizure disorder&#xD;
&#xD;
          -  History of any heart disease including coronary artery disease, heart failure, or&#xD;
             arrhythmias&#xD;
&#xD;
          -  History of altitude sickness&#xD;
&#xD;
          -  Chronic pulmonary conditions that could impair oxygenation&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Current use of oral glucocorticoids, beta-blockers or other medications, which in the&#xD;
             judgement of the investigator, would be a contraindication to participation in the&#xD;
             study.&#xD;
&#xD;
          -  History of ongoing renal disease (other than microalbuminuria).&#xD;
&#xD;
          -  Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir, or&#xD;
             Glargine).&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Presence of a febrile illness within 24 hours of the Ski Admission&#xD;
&#xD;
          -  Medical or psychiatric conditions that in the judgement of the investigator might&#xD;
             interfere with the completion of the protocol such as:&#xD;
&#xD;
               -  Inpatient psychiatric treatment in the past 6 months&#xD;
&#xD;
               -  Uncontrolled adrenal insufficiency&#xD;
&#xD;
               -  Alcohol abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc D. Breton, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia Center for Diabetes Technology</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Chernavvsky DR, Breton MD. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Aug;22(8):594-601. doi: 10.1089/dia.2019.0471. Epub 2020 Mar 2.</citation>
    <PMID>32119790</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Marc Breton</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Artificial Pancreas (AP)</keyword>
  <keyword>Insulin Pump</keyword>
  <keyword>Continuous Glucose Monitor (CGM)</keyword>
  <keyword>MyTDI</keyword>
  <keyword>Hybrid Closed Loop (HCL)</keyword>
  <keyword>Total Daily Insulin (TDI)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Generally, data will be made available after the primary publications of each study.</ipd_time_frame>
    <ipd_access_criteria>Complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to &quot;…generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems&quot; in the target population of people with type 1 diabetes.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>August 11, 2022</submitted>
    <returned>September 7, 2022</returned>
    <submitted>September 21, 2022</submitted>
    <returned>October 19, 2022</returned>
    <submitted>February 13, 2023</submitted>
    <returned>March 9, 2023</returned>
    <submitted>May 16, 2023</submitted>
    <returned>June 9, 2023</returned>
  </pending_results>
  <!-- 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/NCT03804983
org study id: 180030
nct id: NCT03804983
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ
      system, MyTDI.
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin
      parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with
      Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1
      diabetes.

      Once deemed eligible, participants and their parent(s) will be trained on the use of the
      Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system.
      Participants will then use the this study equipment with their home insulin parameters at
      home for at home for 5 days. Participants will then come to the ski resort to participate in
      a 72-hour ski admission. Upon arrival, each participant will be randomized to either the
      using the Control-IQ system with their usual insulin parameters during the ski study and the
      at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and
      the at-home 5 days at home study. Study duration for each participant will require 5 study
      visits over about 2 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) System t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
primary purpose: Other
masking: None (Open Label)
measure: change between Percent Time in Range at home pre/post intervention at home
time frame: 5 days
description: The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in average CGM at home
time frame: 5 days
description: number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.
measure: Change in average CGM at camp
time frame: 2 days
description: number of CGM values falling in this interval divided by the total number of available Average of CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
Days of analysis will be defined as 7am-6:59am. Days will then be averaged over the time frame.
measure: Change in Percent CGM below 50mg/dL at home
time frame: 5 days
description: the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM below 50mg/dL at camp
time frame: 5 days
description: the number of CGM values falling below 50mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM below 54mg/dL at camp
time frame: 2 days
description: the number of CGM values falling below 54mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent below 60mg/dL at home
time frame: 5 days
description: the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent below 60mg/dL at camp
time frame: 2 days
description: the number of CGM values falling below 60mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM below 70mg/dL at home
time frame: 5 days
description: the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM below 70mg/dL at camp
time frame: 2 days
description: the number of CGM values falling below 70mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM between 70mg/dL and 180mg/dL at camp
time frame: 2 days
description: the number of CGM values falling between 70mg/dL and 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM above 180mg/dL at home
time frame: 5 days
description: the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM above 180mg/dL at camp
time frame: 2 days
description: the number of CGM values falling above 180mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM above 250mg/dL at home
time frame: 5 days
description: the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM above 250mg/dL at camp
time frame: 5 days2
description: the number of CGM values falling above 250mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM above 300mg/dL at home
time frame: 5 days
description: the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Percent CGM above 300mg/dL at camp
time frame: 2 days
description: the number of CGM values falling above 300mg/dL divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
measure: Change in Total daily insulin at home
time frame: 5 days
description: sum of the recorded insulin injection over the time frame in units
measure: Change in Total daily insulin at camp
time frame: 2 days
description: sum of the recorded insulin injection over the time frame in units
measure: Change in Total meal carbohydrates at home
time frame: 5 days
description: sum of the meal sized recorded over the time frame
measure: Change in Total meal carbohydrates at camp
time frame: 2 days
description: sum of the meal sized recorded over the time frame
measure: Change in Number of hypoglycemic events at home
time frame: 5 days
description: Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
measure: Change in Number of hypoglycemic events at camp
time frame: 2 days
description: Sum of hypoglycemic events within the time frame. An event is defined by a group of consecutive CGM values below 70 mg/dL)
measure: Change in number of Hypoglycemia treatment at home
time frame: 5 days
description: Sum of the number of CHO treatments recorded over the time frame
measure: Change in number of Hypoglycemia treatment at camp
time frame: 2 days
description: Sum of the number of CHO treatments recorded over the time frame
measure: Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at home
time frame: 5 days
description: Sum of the amount of carbohydrates used for treatments recorded over the time frame
measure: Change in Total amount of carbohydrates corresponding to hypoglycemia treatment at camp
time frame: 2 days
description: Sum of the amount of carbohydrates used for treatments recorded over the time frame
arm group label: Hybrid Closed Loop (HCL)
arm group type: Active Comparator
description: Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ with Hybrid Closed Loop (HCL) or the Control-IQ with MyTDI. Participants randomized to Control-IQ, participants will continue using their home insulin parameters during the ski admission and then 5 additional days at home.
arm group label: Control-IQ with MyTDI
arm group type: Experimental
description: Eligible participants will be screened and enter the data collection period for approximately 5 days at home. Prior to participating in the 72-hour ski admission, participants will be randomized 1:1 to the use of Control-IQ or the Control-IQ with MyTDI. Participants randomized to Control-IQ with MyTDI, participants will be adjusted as noted below during the ski admission and will then continue these parameters for 5 additional days at home:
A single basal rate equal to total daily insulin (TDI)/48 will be implemented across the whole day
A single correction factor (CF) of 1650/TDI will be implemented across the whole day
Carbohydrate ratios (CR) will be set at:
00:00-04:00 CR=450/TDI
04:00-11:00 CR=360/TDI
11:00-00:00 CR=450/TDI TDI will be set at the internal Control-IQ estimation total daily dose; if not available, total daily dose over the last 5 days will be used.
intervention type: Device
intervention name: Hybrid Closed Loop (HCL)
description: Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
arm group label: Hybrid Closed Loop (HCL)
intervention type: Device
intervention name: Control-IQ with MyTDI
description: Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
arm group label: Control-IQ with MyTDI
criteria: 
gender: All
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Marc D. Breton, PhD
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
citation: Schoelwer MJ, Robic JL, Gautier T, Fabris C, Carr K, Clancy-Oliveri M, Brown SA, Anderson SM, DeBoer MD, Chernavvsky DR, Breton MD. Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2020 Aug;22(8):594-601. doi: 10.1089/dia.2019.0471. Epub 2020 Mar 2.
PMID: 32119790
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Marc Breton
investigator title: Principal Investigator
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Generally, data will be made available after the primary publications of each study.
ipd access criteria: Complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "…generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems" in the target population of people with type 1 diabetes.
submitted: August 11, 2022
returned: September 7, 2022
submitted: September 21, 2022
returned: October 19, 2022
submitted: February 13, 2023
returned: March 9, 2023
submitted: May 16, 2023
returned: June 9, 2023