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/NCT06041971</url>
    </required_header>
    <id_info>
      <org_study_id>23-1684</org_study_id>
      <nct_id>NCT06041971</nct_id>
    </id_info>
    <brief_title>Fully Closed Loop at Home (FCL@Home)</brief_title>
    <official_title>Safety and Feasibility Testing of a Fully Closed Loop System in Adolescents and Adults With Higher Baseline HbA1c Values</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gregory Forlenza</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Virginia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Colorado, Denver</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>
        Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing&#xD;
        a session with up to 6 participants with a lower HbA1c (&lt;8.0%) in one of 3 age categories&#xD;
        (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with&#xD;
        a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The&#xD;
        trial will aim to complete a total of 36 participants: 12 total participants within each age&#xD;
        category and 18 participants within each HbA1c category; 12 participants at each site. The&#xD;
        study may enroll up to 70 participants to account for dropouts across the study. The study&#xD;
        will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel&#xD;
        session, participants will undergo a 7 day/6-night remote monitored at-home use session. The&#xD;
        study will also conduct a two-week control period gathering data on glycemic control and&#xD;
        insulin administration with the participants usual care therapy. Participants will be&#xD;
        randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET&#xD;
        use) or group B (control period after AIDANET use).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Treatment Groups Randomized Crossover: Participants will be randomized 1:1 within each age cohort to either conduct the two-week control period before use of the AIDANET system (group A) or after use of the AIDANET system (group B).</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean Sensor Glucose Value</measure>
      <time_frame>Change between second week of the control period and the one-week at home period</time_frame>
      <description>The primary metric for analysis will be change in mean sensor glucose value between the second week of the control usual-care period and the one-week remote monitored at-home FCL period.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Type 1 Diabetes</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Two-week control period before the use of the AIDANET system.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Two-week control period after the use of the AIDANET system.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AIDANET system</intervention_name>
      <description>The study will involve testing a new AID system designed to enable full closed loop control and consisting of the following elements: the diabetes assistant (DiAs) prototyping platform (MAF 2019), connected to a Tandem t:AP research insulin pump and a Dexcom G6 CGM, and implementing the University of Virginia (UVA) AIDANET algorithm.</description>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_label>Group B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age either 14-17, 18-25, or 26-60 years at time of consent.&#xD;
  &#xD;
            2. Clinical diagnosis of T1D, based on investigator assessment, of at least 1 year&#xD;
               duration.&#xD;
  &#xD;
            3. HbA1c either &lt;8.0 or 8.0-12.0% at time of consent.&#xD;
  &#xD;
            4. Currently using insulin for at least 6 months.&#xD;
  &#xD;
            5. Willingness to follow the protocol and sign the informed consent (and assent as&#xD;
               applicable).&#xD;
  &#xD;
            6. Living with one or more parent/guardian or supportive companions knowledgeable about&#xD;
               emergency procedures for severe hypoglycemia and able to contact emergency services&#xD;
               and study staff.&#xD;
  &#xD;
            7. For females, not currently known to be pregnant or breastfeeding.&#xD;
  &#xD;
            8. If female and sexually active, must agree to use a form of contraception to prevent&#xD;
               pregnancy while a participant in the study. A negative serum or urine pregnancy test&#xD;
               will be required for all females of childbearing potential. Participants who become&#xD;
               pregnant will be discontinued from the study. Also, participants who during the study&#xD;
               develop and express the intention to become pregnant within the timespan of the study&#xD;
               will be discontinued.&#xD;
  &#xD;
            9. Willingness to switch to use a commercially approved personal insulin (e.g., lispro or&#xD;
               aspart, or biosimilar approved products) within the study pump as directed by the&#xD;
               study team.&#xD;
  &#xD;
           10. Currently using an insulin pump for at least the prior 6 months. Any commercially&#xD;
               approved pump, either open loop or hybrid closed loop may be used.&#xD;
  &#xD;
           11. Willingness to suspend use of any personal CGM other than Dexcom G6 once the DiAs&#xD;
               system is in use. Participants may use their own Dexcom G6 during the study period.&#xD;
  &#xD;
           12. Willingness to use the study FCL system (CGM, pump, and phone) during the relevant&#xD;
               study period.&#xD;
  &#xD;
           13. Willingness not to start any new non-insulin glucose-lowering agent during the course&#xD;
               of the trial.&#xD;
  &#xD;
           14. Willingness to participate in all study procedures including the house/hotel session,&#xD;
               exercise challenges (e.g., one hour per day during hotel), and to consume&#xD;
               approximately 3 unannounced meals per day during the relevant portion of the&#xD;
               supervised hotel session.&#xD;
  &#xD;
           15. Access to internet at home and willingness to upload data during the study as needed.&#xD;
  &#xD;
           16. Investigator has confidence that the participant can successfully operate all study&#xD;
               devices and is capable of adhering to the protocol.&#xD;
  &#xD;
           17. Participant is proficient in reading and writing English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor&#xD;
               agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable&#xD;
               dose of such an agent for at least the past month.&#xD;
  &#xD;
            2. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.&#xD;
  &#xD;
            3. Hemophilia or any other bleeding disorder.&#xD;
  &#xD;
            4. History of severe hypoglycemic event with seizure or loss of consciousness in the last&#xD;
               12 months.&#xD;
  &#xD;
            5. History of DKA event in the last 12 months.&#xD;
  &#xD;
            6. History of chronic renal disease (CKD3b or 4) or currently on peritoneal or&#xD;
               hemodialysis.&#xD;
  &#xD;
            7. History of adrenal insufficiency.&#xD;
  &#xD;
            8. Currently being treated for a seizure disorder.&#xD;
  &#xD;
            9. Hypothyroidism or hyperthyroidism that is not adequately treated.&#xD;
  &#xD;
           10. Coronary artery disease or other heart condition that would prevent participation in&#xD;
               moderate intensity exercise.&#xD;
  &#xD;
           11. Use of oral or injectable steroids at the time of enrollment or within the last 4&#xD;
               weeks.&#xD;
  &#xD;
           12. Planned surgery during the study period.&#xD;
  &#xD;
           13. Known ongoing adhesive intolerance that is not well managed.&#xD;
  &#xD;
           14. A condition, which in the opinion of the investigator or designee, would put the&#xD;
               participant or study at risk.&#xD;
  &#xD;
           15. Participation in another interventional trial at the time of enrollment.&#xD;
  &#xD;
           16. Participant does not have a direct supervisor involved in the conduct of the trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gregory P Forlenza, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Colorado Anschutz - Barbara Davis Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lindsey Towers</last_name>
      <phone>303-724-8620</phone>
      <email>Lindsey.Towers@cuanschutz.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Estella Escobar</last_name>
      <phone>303-724-7775</phone>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Colorado, Denver</investigator_affiliation>
      <investigator_full_name>Gregory Forlenza</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <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>No</sharing_ipd>
    </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/NCT06041971
  org study id: 23-1684
  nct id: NCT06041971
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing
        a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories
        (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with
        a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The
        trial will aim to complete a total of 36 participants: 12 total participants within each age
        category and 18 participants within each HbA1c category; 12 participants at each site. The
        study may enroll up to 70 participants to account for dropouts across the study. The study
        will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel
        session, participants will undergo a 7 day/6-night remote monitored at-home use session. The
        study will also conduct a two-week control period gathering data on glycemic control and
        insulin administration with the participants usual care therapy. Participants will be
        randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET
        use) or group B (control period after AIDANET use).
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Treatment Groups Randomized Crossover: Participants will be randomized 1:1 within each age cohort to either conduct the two-week control period before use of the AIDANET system (group A) or after use of the AIDANET system (group B).
  primary purpose: Other
  masking: None (Open Label)
  measure: Mean Sensor Glucose Value
  time frame: Change between second week of the control period and the one-week at home period
  description: The primary metric for analysis will be change in mean sensor glucose value between the second week of the control usual-care period and the one-week remote monitored at-home FCL period.
  arm group label: Group A
  arm group type: Experimental
  description: Two-week control period before the use of the AIDANET system.
  arm group label: Group B
  arm group type: Experimental
  description: Two-week control period after the use of the AIDANET system.
  intervention type: Device
  intervention name: AIDANET system
  description: The study will involve testing a new AID system designed to enable full closed loop control and consisting of the following elements: the diabetes assistant (DiAs) prototyping platform (MAF 2019), connected to a Tandem t:AP research insulin pump and a Dexcom G6 CGM, and implementing the University of Virginia (UVA) AIDANET algorithm.
  arm group label: Group A
  arm group label: Group B
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Gregory P Forlenza, MD
  role: Principal Investigator
  affiliation: University of Colorado Anschutz - Barbara Davis Center
  last name: Lindsey Towers
  phone: 303-724-8620
  email: Lindsey.Towers@cuanschutz.edu
  last name: Estella Escobar
  phone: 303-724-7775
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Colorado, Denver
  investigator full name: Gregory Forlenza
  investigator title: Associate Professor
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No