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/NCT06017089</url>
    </required_header>
    <id_info>
      <org_study_id>230262</org_study_id>
      <secondary_id>U01DK127551-03</secondary_id>
      <nct_id>NCT06017089</nct_id>
    </id_info>
    <brief_title>The Pediatric Artificial Pancreas Automated Initialization Trial</brief_title>
    <acronym>PEDAP-AI</acronym>
    <official_title>The Pediatric Artificial Pancreas Automated Initialization Trial (PEDAP-AI): A Pilot Study of AI Advisor-Driven Pump Initiation and Parameter Adaptation in Young Children With Type 1 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marc Breton</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jaeb Center for Health Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Virginia</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this clinical trial is to obtain safety data and exploratory glycemic control&#xD;
        data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ&#xD;
        Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young&#xD;
        children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and&#xD;
        efficacy of the use of the AI-driven pump parameters. Participants will use the study system&#xD;
        (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and&#xD;
        parameter adaptation in youth age 2 to &lt;6 years old, participants will use the Tandem t:slim&#xD;
        X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to&#xD;
        the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home. The&#xD;
        key safety outcomes are time spent below 54mg/dL and time spent above 250mg/dL compared with&#xD;
        baseline and with a matched historical control population over the same time period from the&#xD;
        prior PEDAP study that did not involve the use of any AI-driven pump parameters. Severe&#xD;
        hypoglycemia and diabetic ketoacidosis episodes will also be reported. Glycemic outcomes&#xD;
        including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and&#xD;
        hyperglycemia will be assessed and compared with baseline and the PEDAP historical control&#xD;
        mentioned above. Up to 45 screened participants with the goal of at least 30 participants&#xD;
        completing the study pump use period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Safety Endpoint (Hyperglycemia)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The percent of time spent above 250 mg/dL between the 8 weeks follow-up and baseline</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Primary Safety Endpoint (Hypoglycemia)</measure>
      <time_frame>8 weeks</time_frame>
      <description>The percent of time spent below 54 mg/dL between the 8 weeks follow-up and baseline</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CGM Measured Time in Range</measure>
      <time_frame>8 weeks</time_frame>
      <description>The percent of time spent within range, 70 mg/dL-180 mg/dL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CGM Measured Mean Glucose</measure>
      <time_frame>8 weeks</time_frame>
      <description>The average of the CGM values measured and collected within the 8-week data collection period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CGM Measured Hypoglycemia</measure>
      <time_frame>8 weeks</time_frame>
      <description>The percent of time spent below 70 mg/dL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CGM Measured Glucose Coefficient of Variation</measure>
      <time_frame>8 weeks</time_frame>
      <description>Observed glucose variability ((standard deviation/mean)x100)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binary outcome 1</measure>
      <time_frame>8 weeks</time_frame>
      <description>% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥5%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binary outcome 2</measure>
      <time_frame>8 weeks</time_frame>
      <description>% Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥10%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binary outcome 3</measure>
      <time_frame>8 weeks</time_frame>
      <description>% Time in range 70-180 mg/dL &gt;70% and % time &lt;70 mg/dL &lt;4%</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total daily insulin</measure>
      <time_frame>8 weeks</time_frame>
      <description>Total daily insulin (units/kg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Basal Insulin</measure>
      <time_frame>8 weeks</time_frame>
      <description>Percentage of total insulin delivered via basal administration.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Type 1 Diabetes</condition>
    <arm_group>
      <arm_group_label>AI Advisor-driven at-home closed loop system initiation and parameter adaptation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AI-based Advisor system</intervention_name>
      <description>Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system.</description>
      <arm_group_label>AI Advisor-driven at-home closed loop system initiation and parameter adaptation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least&#xD;
               3 months&#xD;
  &#xD;
            2. Familiarity and use of a carbohydrate ratio for meal boluses&#xD;
  &#xD;
            3. Age ≥2 and &lt;6 years old&#xD;
  &#xD;
            4. Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior&#xD;
               28 days&#xD;
  &#xD;
            5. Living with one or more parent/legal guardian knowledgeable about emergency procedures&#xD;
               for severe hypoglycemia and able to contact emergency services and study staff&#xD;
  &#xD;
            6. Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically&#xD;
               Android 10 or above or iPhone Operating System (iOS) 15 or above)&#xD;
  &#xD;
            7. Willingness to use the t:connect Mobile App as needed during the study and ensure&#xD;
               connectivity for a data upload at least once per day&#xD;
  &#xD;
            8. Investigator has confidence that the parent can successfully operate all study devices&#xD;
               and is capable of adhering to the protocol&#xD;
  &#xD;
            9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already,&#xD;
               and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the&#xD;
               study for participants using a study162 provided Tandem pump during the study&#xD;
  &#xD;
           10. Total daily insulin dose (TDD) at least 5 Units/day&#xD;
  &#xD;
           11. Body weight at least 20 pounds (lbs)&#xD;
  &#xD;
           12. Willingness not to start any new non-insulin glucose-lowering agent during the course&#xD;
               of the trial&#xD;
  &#xD;
           13. Participant and parent(s)/guardian(s) willingness to participate in all training&#xD;
               sessions as directed by study staff&#xD;
  &#xD;
           14. Parent/guardian proficient in reading and writing English&#xD;
  &#xD;
           15. Live in the United States, with no plans to move outside the United States during the&#xD;
               study period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Currently using an insulin pump&#xD;
  &#xD;
            2. Concurrent use of any non-insulin glucose-lowering agent (including glucagon- like&#xD;
               peptide (GLP)-1 agonists, Symlin, dipeptidyl peptidase (DPP)-4 inhibitors,&#xD;
               sodium-glucose cotransporter (SGLT)-2 inhibitors, sulfonylureas)&#xD;
  &#xD;
            3. Hemophilia or any other bleeding disorder&#xD;
  &#xD;
            4. History of &gt;1 severe hypoglycemic event with seizure or loss of consciousness in the&#xD;
               last 3 months&#xD;
  &#xD;
            5. History of &gt;1 Diabetic Ketoacidosis (DKA) event in the last 6 months not related to&#xD;
               illness, infusion set failure, or initial diagnosis&#xD;
  &#xD;
            6. History of chronic renal disease or currently on hemodialysis&#xD;
  &#xD;
            7. History of adrenal insufficiency&#xD;
  &#xD;
            8. Hypothyroidism that is not adequately treated in the opinion of the investigator&#xD;
  &#xD;
            9. Use of oral or injectable steroids within the last 8 weeks&#xD;
  &#xD;
           10. Known, ongoing adhesive intolerance&#xD;
  &#xD;
           11. Plans to receive blood transfusions or erythropoietin injections during the course of&#xD;
               the study&#xD;
  &#xD;
           12. A condition, which in the opinion of the investigator or designee, would put the&#xD;
               participant or study at risk&#xD;
  &#xD;
           13. Participation in another pharmaceutical or device trial at the time of enrollment or&#xD;
               during the study&#xD;
  &#xD;
           14. Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom,&#xD;
               Inc., or having a direct supervisor at place of employment who is also directly&#xD;
               involved in conducting the clinical trial (as a study investigator, coordinator,&#xD;
               etc.); or having a first-degree relative who is directly involved in conducting the&#xD;
               clinical trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John Lum, MS</last_name>
      <role>Study Director</role>
      <affiliation>Jaeb Center for Health Research</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Raj Paul Wadwa, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Barbara Davis Center, University of Colorado</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Marc D Breton, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>University of Virginia Center for Diabetes Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marc D Breton, Ph.D.</last_name>
      <phone>4349826484</phone>
      <email>mb6nt@virginia.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Emma G Emory, RN</last_name>
      <phone>4342433992</phone>
      <email>ee9m@uvahealth.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford University</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Bruce Buckingham, MD</last_name>
        <phone>650-723-5791</phone>
        <email>buckingham@stanford.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Barbara Davis Center, University of Colorado</name>
        <address>
          <city>Aurora</city>
          <state>Colorado</state>
          <zip>80045</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Raj Paul Wadwa, MD</last_name>
        <email>paul.wadwa@cuanschutz.edu</email>
      </contact>
      <investigator>
        <last_name>Raj Paul Wadwa, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Virginia</name>
        <address>
          <city>Charlottesville</city>
          <state>Virginia</state>
          <zip>22903</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Marc D Breton, Ph.D.</last_name>
        <phone>434-982-6484</phone>
        <email>mb6nt@virginia.edu</email>
      </contact>
      <investigator>
        <last_name>Marc D Breton, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mark D DeBoer, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Melissa J Schoelwer, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-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>Type 1 Diabetes</keyword>
    <keyword>Continuous Glucose Monitor (CGM)</keyword>
    <keyword>Tandem t:slim Insulin Pump with Control-IQ Technology</keyword>
    <keyword>Control-IQ Technology (CIQ)</keyword>
    <keyword>Artificial Pancreas (AP)</keyword>
    <keyword>Artificial Intelligence (AI)</keyword>
    <keyword>Closed loop control (CLC)</keyword>
    <keyword>Diabetes Assistant (DiAs)</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 in 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>Data will be made available after the primary publications of each study site.</ipd_time_frame>
      <ipd_access_criteria>The Data Sharing Agreements will be formulated by the study team.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT06017089
  org study id: 230262
  secondary id: U01DK127551-03
  nct id: NCT06017089
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The goal of this clinical trial is to obtain safety data and exploratory glycemic control
        data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ
        Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young
        children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and
        efficacy of the use of the AI-driven pump parameters. Participants will use the study system
        (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
  In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and
        parameter adaptation in youth age 2 to <6 years old, participants will use the Tandem t:slim
        X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to
        the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home. The
        key safety outcomes are time spent below 54mg/dL and time spent above 250mg/dL compared with
        baseline and with a matched historical control population over the same time period from the
        prior PEDAP study that did not involve the use of any AI-driven pump parameters. Severe
        hypoglycemia and diabetic ketoacidosis episodes will also be reported. Glycemic outcomes
        including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and
        hyperglycemia will be assessed and compared with baseline and the PEDAP historical control
        mentioned above. Up to 45 screened participants with the goal of at least 30 participants
        completing the study pump use period.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Primary Safety Endpoint (Hyperglycemia)
  time frame: 8 weeks
  description: The percent of time spent above 250 mg/dL between the 8 weeks follow-up and baseline
  measure: Primary Safety Endpoint (Hypoglycemia)
  time frame: 8 weeks
  description: The percent of time spent below 54 mg/dL between the 8 weeks follow-up and baseline
  measure: CGM Measured Time in Range
  time frame: 8 weeks
  description: The percent of time spent within range, 70 mg/dL-180 mg/dL.
  measure: CGM Measured Mean Glucose
  time frame: 8 weeks
  description: The average of the CGM values measured and collected within the 8-week data collection period.
  measure: CGM Measured Hypoglycemia
  time frame: 8 weeks
  description: The percent of time spent below 70 mg/dL.
  measure: CGM Measured Glucose Coefficient of Variation
  time frame: 8 weeks
  description: Observed glucose variability ((standard deviation/mean)x100)
  measure: Binary outcome 1
  time frame: 8 weeks
  description: % Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥5%
  measure: Binary outcome 2
  time frame: 8 weeks
  description: % Time in range 70-180 mg/dL improvement from baseline to 8 weeks ≥10%
  measure: Binary outcome 3
  time frame: 8 weeks
  description: % Time in range 70-180 mg/dL >70% and % time <70 mg/dL <4%
  measure: Total daily insulin
  time frame: 8 weeks
  description: Total daily insulin (units/kg)
  measure: Basal Insulin
  time frame: 8 weeks
  description: Percentage of total insulin delivered via basal administration.
  arm group label: AI Advisor-driven at-home closed loop system initiation and parameter adaptation
  arm group type: Experimental
  description: In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system.
  intervention type: Device
  intervention name: AI-based Advisor system
  description: Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system.
  arm group label: AI Advisor-driven at-home closed loop system initiation and parameter adaptation
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 5 Years
  healthy volunteers: No
  last name: John Lum, MS
  role: Study Director
  affiliation: Jaeb Center for Health Research
  last name: Raj Paul Wadwa, MD
  role: Principal Investigator
  affiliation: Barbara Davis Center, University of Colorado
  last name: Marc D Breton, Ph.D.
  role: Study Chair
  affiliation: University of Virginia Center for Diabetes Technology
  last name: Marc D Breton, Ph.D.
  phone: 4349826484
  email: mb6nt@virginia.edu
  last name: Emma G Emory, RN
  phone: 4342433992
  email: ee9m@uvahealth.org
  facility: 
  contact: 
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor-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 in 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: Data will be made available after the primary publications of each study site.
  ipd access criteria: The Data Sharing Agreements will be formulated by the study team.