<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/NCT04503174</url>
  </required_header>
  <id_info>
    <org_study_id>CLIO Study</org_study_id>
    <nct_id>NCT04503174</nct_id>
  </id_info>
  <brief_title>Control-IQ Observational (CLIO) Post-Approval Study</brief_title>
  <acronym>CLIO</acronym>
  <official_title>Control-IQ Observational (CLIO) Post-Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tandem Diabetes Care, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tandem Diabetes Care, Inc.</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_ppsd>Yes</is_ppsd>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-approval study designed to collect primarily safety data on the US FDA-cleared product,&#xD;
      t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-approval study designed to collect primarily safety data on the US FDA-cleared product,&#xD;
      t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate&#xD;
      of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of&#xD;
      use. Secondary endpoints assessing the effectiveness of this product in real-world use by&#xD;
      assessing the impact on patients' glycemic outcomes and user experience will also be&#xD;
      collected. The Control-IQ system will be used as intended and in accordance with FDA-approved&#xD;
      labeling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Actual">June 26, 2023</completion_date>
  <primary_completion_date type="Actual">June 2, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Incidence rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA)</measure>
    <time_frame>12 months</time_frame>
    <description>Overall incidence rate of X events per 100 patient years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety of the automatic population of CGM readings into the bolus calculator of the Control-IQ system</measure>
    <time_frame>12 months</time_frame>
    <description>Correlating the incidence of AE with the use of the calculator and associated CGM readings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic Outcomes as a measure of efficacy of the Control-IQ system</measure>
    <time_frame>12 months</time_frame>
    <description>means/medians as appropriate based on the data extracted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported satisfaction with and trust in the Control-IQ system, usability of the system, and sleep quality</measure>
    <time_frame>12 months</time_frame>
    <description>means/medians as appropriate based on the data extracted</description>
  </secondary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Actual">3198</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Pump Naiive</arm_group_label>
    <description>New to insulin pump use</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6-13 YO</arm_group_label>
    <description>Subjects between the age of 6-13 years old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>14-17 YO</arm_group_label>
    <description>Subjects between the age of 14-17 years old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adults (18+)</arm_group_label>
    <description>Subjects are 18 years old and older.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CGM Naiive</arm_group_label>
    <description>Subjects have not used CGM in the 30 days prior to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HbA1c more than or equal to 8.5%</arm_group_label>
    <description>Subjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HbA1c less than or equal to 8.5%</arm_group_label>
    <description>Subjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>t:slim X2 pump with Control-IQ technology</intervention_name>
    <description>Real-world use</description>
    <arm_group_label>14-17 YO</arm_group_label>
    <arm_group_label>6-13 YO</arm_group_label>
    <arm_group_label>Adults (18+)</arm_group_label>
    <arm_group_label>CGM Naiive</arm_group_label>
    <arm_group_label>HbA1c less than or equal to 8.5%</arm_group_label>
    <arm_group_label>HbA1c more than or equal to 8.5%</arm_group_label>
    <arm_group_label>Pump Naiive</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects who start therapy with the Control-IQ System once the study is approved to&#xD;
        start, that meet the indications for use and the study eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with self-reported type 1 diabetes who have been prescribed the Control-IQ&#xD;
             system.&#xD;
&#xD;
          -  At least 6 years of age&#xD;
&#xD;
          -  Using Humalog or Novolog insulin&#xD;
&#xD;
          -  For females, not pregnant or planning pregnancy in the next 12 months.&#xD;
&#xD;
          -  Agreement to use the t:slim X2 with Control-IQ technology, and to continue use for at&#xD;
             least 12 consecutive months after study enrollment.&#xD;
&#xD;
          -  Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.&#xD;
&#xD;
          -  Ability to respond to alerts and alarms, and to provide basic diabetes&#xD;
             self-management.&#xD;
&#xD;
          -  Patients who reside full-time in the United States.&#xD;
&#xD;
          -  Willingness to download the t:connect Mobile application to their Smartphone and keep&#xD;
             it active throughout the study. Patients unable to use t:connect Mobile application&#xD;
             must be willing to manually upload their insulin pump data to t:connect every three&#xD;
             months and at the completion of the study.&#xD;
&#xD;
          -  Subject has read, understood and agreed to participate in the study, and has&#xD;
             electronically signed the Informed Consent Form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-reported type 2 diabetes&#xD;
&#xD;
          -  &lt; 6 years of age&#xD;
&#xD;
          -  Use of any glucose-lowering therapy other than Humalog or Novolog insulin&#xD;
&#xD;
          -  Inability to respond to alerts and alarms, or to provide basic diabetes&#xD;
             self-management.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Subjects who have not signed the ICF.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jordan Pinsker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tandem Diabetes Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tandem Diabetes</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>


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/NCT04503174
org study id: CLIO Study
nct id: NCT04503174
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is ppsd: Yes
Post-approval study designed to collect primarily safety data on the US FDA-cleared product,
      t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).
Post-approval study designed to collect primarily safety data on the US FDA-cleared product,
      t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate
      of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of
      use. Secondary endpoints assessing the effectiveness of this product in real-world use by
      assessing the impact on patients' glycemic outcomes and user experience will also be
      collected. The Control-IQ system will be used as intended and in accordance with FDA-approved
      labeling.
observational model: Case-Control
time perspective: Other
measure: Incidence rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA)
time frame: 12 months
description: Overall incidence rate of X events per 100 patient years
measure: Safety of the automatic population of CGM readings into the bolus calculator of the Control-IQ system
time frame: 12 months
description: Correlating the incidence of AE with the use of the calculator and associated CGM readings.
measure: Glycemic Outcomes as a measure of efficacy of the Control-IQ system
time frame: 12 months
description: means/medians as appropriate based on the data extracted
measure: Patient-reported satisfaction with and trust in the Control-IQ system, usability of the system, and sleep quality
time frame: 12 months
description: means/medians as appropriate based on the data extracted
arm group label: Pump Naiive
description: New to insulin pump use
arm group label: 6-13 YO
description: Subjects between the age of 6-13 years old.
arm group label: 14-17 YO
description: Subjects between the age of 14-17 years old.
arm group label: Adults (18+)
description: Subjects are 18 years old and older.
arm group label: CGM Naiive
description: Subjects have not used CGM in the 30 days prior to enrollment.
arm group label: HbA1c more than or equal to 8.5%
description: Subjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment.
arm group label: HbA1c less than or equal to 8.5%
description: Subjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment.
intervention type: Device
intervention name: t:slim X2 pump with Control-IQ technology
description: Real-world use
arm group label: 14-17 YO
arm group label: 6-13 YO
arm group label: Adults (18+)
arm group label: CGM Naiive
arm group label: HbA1c less than or equal to 8.5%
arm group label: HbA1c more than or equal to 8.5%
arm group label: Pump Naiive
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Jordan Pinsker, MD
role: Principal Investigator
affiliation: Tandem Diabetes Care, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No