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/NCT06024928</url>
    </required_header>
    <id_info>
      <org_study_id>230316</org_study_id>
      <nct_id>NCT06024928</nct_id>
    </id_info>
    <brief_title>Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes</brief_title>
    <acronym>AID-BIT</acronym>
    <official_title>Short Use of Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Virginia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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 clinical trial is to test the safety and feasibility of using an&#xD;
        Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections&#xD;
        to achieve safe and fast basal insulin titration. Participants will be randomized to either&#xD;
        the control group or the experimental group. If in the experimental group, the participant&#xD;
        will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days.&#xD;
        Researchers will compare the glycemic control of the experimental group to the control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will involve 20 people with Type 2 Diabetes who are 18 years or older. The study&#xD;
        will be performed at the University of Virginia (UVA), with screening procedures taking place&#xD;
        either virtually or at the Clinical Research Unit (CRU) at UVA. All participants will undergo&#xD;
        a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor (CGM).&#xD;
        Participants will be randomized (1:1) to either the Control (CTR) Group or the Experimental&#xD;
        (EXP) Group. In the EXP Group, participants will use an Automated Insulin Device (AID) for 10&#xD;
        days in the Basal Insulin Titration (BIT) Phase then return to their original therapy (basal&#xD;
        insulin using pen) using the new setting in the Maintenance Phase (MP). The total daily&#xD;
        insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.&#xD;
        During the same 10 days, in the CTR group, participants will use an unblinded CGM and will be&#xD;
        contacted by a study physician as per standard care to adjust their insulin doses if needed.&#xD;
        Both groups will then go into a 10-days maintenance period using a blinded CGM. Outcomes will&#xD;
        be measured in the last 7 days of the BIT and Maintenance Phases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 14, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This study is a randomized controlled parallel design trial where participants will be randomized 1:1 to either a control group or an experimental group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>System Testing survey</measure>
      <time_frame>14 days</time_frame>
      <description>Receiving feedback from the participants regarding system functionality.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percent Time in Range</measure>
      <time_frame>14 days</time_frame>
      <description>The percent of time spent within glycemic range of 70 to 180 mg/mL.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent Time Below Range</measure>
      <time_frame>14 days</time_frame>
      <description>The percent of time spent below 70 mg/mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Time Above Range</measure>
      <time_frame>14 days</time_frame>
      <description>The percent of time spent above 180 mg/mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Time in Tighter Range</measure>
      <time_frame>14 days</time_frame>
      <description>The percent of time spent within glycemic range of 70 to 140 mg/mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Time Below Range (Hypoglycemia)</measure>
      <time_frame>14 days</time_frame>
      <description>The percent of time spent below 54 mg/mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Time Above Range (Hyperglycemia)</measure>
      <time_frame>14 days</time_frame>
      <description>The percent of time spent above 250 mg/mL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean glucose reading measured by Continuous Glucose Monitor (CGM)</measure>
      <time_frame>14 days</time_frame>
      <description>Glucose variability measured by coefficient of variation.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Automated Insulin Delivery in the Basal Insulin Titration Phase</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will use Automated Insulin Delivery (AID) for 10 days in the Basal Insulin Titration (BIT) Phase. This group will then return to their original home therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP) with a blinded CGM. The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Care with Study Continuous Glucose Monitor</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will use a study Continuous Glucose Monitor (CGM) along with their original home therapy and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. This group will then transition into a 10-day Maintenance Phase (MP) using a blinded CGM, where the basal dose will be maintained.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Control-IQ use in Type 2 Diabetes under basal insulin injections</intervention_name>
      <description>Testing the safety and feasibility of using Automated Insulin Delivery (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration.</description>
      <arm_group_label>Automated Insulin Delivery in the Basal Insulin Titration Phase</arm_group_label>
      <other_name>Tandem Diabetes Care</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18.0 years old at time of consent.&#xD;
  &#xD;
            2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least&#xD;
               one year.&#xD;
  &#xD;
            3. HbA1c ≥ 7.5%.&#xD;
  &#xD;
            4. Currently using an approved long-acting insulin for at least six months (e.g., insulin&#xD;
               glargine, insulin degludec)&#xD;
  &#xD;
            5. Willingness to discontinue a personal CGM during the duration of the study.&#xD;
  &#xD;
            6. Access to the internet and willingness to upload data during the study as needed.&#xD;
  &#xD;
            7. 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;
            8. Willingness not to start any new non-insulin glucose-lowering agent during the trial&#xD;
               (including metformin/biguanides, Glucagon-like peptide (GLP)-1 receptor agonists,&#xD;
               pramlintide, Dipeptidyl peptidase (DPP)-4 inhibitors, sulfonylureas and&#xD;
               nutraceuticals).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Treatment with meglitinides/sulfonylureas.&#xD;
  &#xD;
            2. Currently using an approved intermediate (e.g., insulin Neutral Protamine Hagedorn&#xD;
               (NPH)) or rapid insulin for at least six months (e.g., insulin aspart, insulin lispro,&#xD;
               insulin regular).&#xD;
  &#xD;
            3. Currently being treated for a seizure disorder.&#xD;
  &#xD;
            4. A known medical condition that in the judgment of the investigator might interfere&#xD;
               with the completion of the protocol, such as but not limited to, the following&#xD;
               examples: a) Inpatient psychiatric treatment in the past 6 months, b) Presence of a&#xD;
               known adrenal disorder, c) Uncontrolled thyroid disease.&#xD;
  &#xD;
            5. Currently pregnant or intent to become pregnant during the trial.&#xD;
  &#xD;
            6. Currently breastfeeding.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anas El Fathi, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Virginia Center for Diabetes Technology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ralf M Nass, MD</last_name>
      <phone>434-982-0868</phone>
      <email>rmn9a@uvahealth.org</email>
    </overall_contact>
    <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>
      <contact>
        <last_name>Ralf M Nass, MD</last_name>
        <phone>434-982-0868</phone>
        <email>rmn9a@uvahealth.org</email>
      </contact>
      <contact_backup>
        <last_name>Lianna H Smith</last_name>
        <phone>434-466-4856</phone>
        <email>lhs7px@uvahealth.org</email>
      </contact_backup>
      <investigator>
        <last_name>Ralf M Nass, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Boris Kovatchev, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Anas El Fathi, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Virginia</investigator_affiliation>
      <investigator_full_name>Anas El Fathi</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Automated Insulin Delivery (AID)</keyword>
    <keyword>Continuous Glucose Monitor (CGM)</keyword>
    <keyword>Tandem t:slim Insulin Pump with Control-IQ Technology (CIQ)</keyword>
    <keyword>Basal Insulin Titration (BIT)</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 2</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin</mesh_term>
    </intervention_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 the study.</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/NCT06024928
  org study id: 230316
  nct id: NCT06024928
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  The purpose of this clinical trial is to test the safety and feasibility of using an
        Automated Insulin Device (AID) in people with Type 2 Diabetes under basal insulin injections
        to achieve safe and fast basal insulin titration. Participants will be randomized to either
        the control group or the experimental group. If in the experimental group, the participant
        will use an insulin pump with Control-IQ Technology (Tandem Diabetes Care) for ten days.
        Researchers will compare the glycemic control of the experimental group to the control group.
  The study will involve 20 people with Type 2 Diabetes who are 18 years or older. The study
        will be performed at the University of Virginia (UVA), with screening procedures taking place
        either virtually or at the Clinical Research Unit (CRU) at UVA. All participants will undergo
        a 10-day run-in phase with a blinded Dexcom Generation 6 Continuous Glucose Monitor (CGM).
        Participants will be randomized (1:1) to either the Control (CTR) Group or the Experimental
        (EXP) Group. In the EXP Group, participants will use an Automated Insulin Device (AID) for 10
        days in the Basal Insulin Titration (BIT) Phase then return to their original therapy (basal
        insulin using pen) using the new setting in the Maintenance Phase (MP). The total daily
        insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.
        During the same 10 days, in the CTR group, participants will use an unblinded CGM and will be
        contacted by a study physician as per standard care to adjust their insulin doses if needed.
        Both groups will then go into a 10-days maintenance period using a blinded CGM. Outcomes will
        be measured in the last 7 days of the BIT and Maintenance Phases.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is a randomized controlled parallel design trial where participants will be randomized 1:1 to either a control group or an experimental group.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: System Testing survey
  time frame: 14 days
  description: Receiving feedback from the participants regarding system functionality.
  measure: Percent Time in Range
  time frame: 14 days
  description: The percent of time spent within glycemic range of 70 to 180 mg/mL.
  measure: Percent Time Below Range
  time frame: 14 days
  description: The percent of time spent below 70 mg/mL.
  measure: Percent Time Above Range
  time frame: 14 days
  description: The percent of time spent above 180 mg/mL.
  measure: Percent Time in Tighter Range
  time frame: 14 days
  description: The percent of time spent within glycemic range of 70 to 140 mg/mL.
  measure: Percent Time Below Range (Hypoglycemia)
  time frame: 14 days
  description: The percent of time spent below 54 mg/mL.
  measure: Percent Time Above Range (Hyperglycemia)
  time frame: 14 days
  description: The percent of time spent above 250 mg/mL.
  measure: Mean glucose reading measured by Continuous Glucose Monitor (CGM)
  time frame: 14 days
  description: Glucose variability measured by coefficient of variation.
  arm group label: Automated Insulin Delivery in the Basal Insulin Titration Phase
  arm group type: Experimental
  description: Participants will use Automated Insulin Delivery (AID) for 10 days in the Basal Insulin Titration (BIT) Phase. This group will then return to their original home therapy (basal insulin using pen) using the new setting in the Maintenance Phase (MP) with a blinded CGM. The total daily insulin (TDI) requirement during the BIT Phase will be translated to a basal insulin dose.
  arm group label: Standard Care with Study Continuous Glucose Monitor
  arm group type: No Intervention
  description: Participants will use a study Continuous Glucose Monitor (CGM) along with their original home therapy and will be contacted by a study physician as per standard care to adjust their insulin doses if needed. This group will then transition into a 10-day Maintenance Phase (MP) using a blinded CGM, where the basal dose will be maintained.
  intervention type: Device
  intervention name: Control-IQ use in Type 2 Diabetes under basal insulin injections
  description: Testing the safety and feasibility of using Automated Insulin Delivery (AID) in people with Type 2 Diabetes under basal insulin injections to achieve safe and fast basal insulin titration.
  arm group label: Automated Insulin Delivery in the Basal Insulin Titration Phase
  other name: Tandem Diabetes Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anas El Fathi, PhD
  role: Principal Investigator
  affiliation: University of Virginia Center for Diabetes Technology
  last name: Ralf M Nass, MD
  phone: 434-982-0868
  email: rmn9a@uvahealth.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Virginia
  investigator full name: Anas El Fathi
  investigator title: Principal Investigator
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Insulin
  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 the study.
  ipd access criteria: The Data Sharing Agreements will be formulated by the study team.