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/NCT05969106</url>
    </required_header>
    <id_info>
      <org_study_id>VastraGotaland - 2022-00332-01</org_study_id>
      <nct_id>NCT05969106</nct_id>
    </id_info>
    <brief_title>Tandem Control-IQ Evaluation Regarding Glucose Metrics, Sleep, and Health Economics</brief_title>
    <acronym>STARCARE</acronym>
    <official_title>A Study Comparing Tandem Control-IQ With Real-time Continuous Glucose Monitoring (rtCGM) Used Together With Insulin Pens and Insulin Pumps for 18 Months</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vastra Gotaland Region</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vastra Gotaland Region</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_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and&#xD;
        insulin pump treatment in children and adolescents regarding glucose control, sleep and&#xD;
        health economics for 18 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health&#xD;
        economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily&#xD;
        insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM&#xD;
        (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the&#xD;
        three modalities for at least six months were included in the analysis. Inclusion required&#xD;
        all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only&#xD;
        insulin treatment differentiated the three groups. Comparisons were conducted regarding&#xD;
        Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1&#xD;
        month before the study started until 18 months. Sleep quality and quantity were assessed&#xD;
        using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct&#xD;
        costs in all healthcare systems and additional information on sick leaves were collected from&#xD;
        the Swedish Social Insurance Agency. Comparisons were then made between the three treatment&#xD;
        alternatives.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Actual">December 30, 2022</completion_date>
    <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Glycemic metrics</measure>
      <time_frame>Change from baseline to 6, 12 and 18 months</time_frame>
      <description>Time in range (TIR), Time below range (TBR) Level 1 and 2, Time above range (TAR) Level 1 and 2, Time in tighter range (TITR)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep</measure>
      <time_frame>At study completion at 12 months.</time_frame>
      <description>Quantity and quality are defined in the questionnaire. Assessment by a 10-point Likert scale (1= &quot;Worst possible&quot;, 10= &quot;Best possible&quot;)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Costs - direct</measure>
      <time_frame>From baseline until study completion at 18 months</time_frame>
      <description>Cost for the insulin administration devices and continuous glucose monitoring devices per person/year (direct). All costa are calculated in Swedish currency (SEK).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Costs - indirect</measure>
      <time_frame>From baseline until study completion at 18 months</time_frame>
      <description>Cost for comorbidities and all health-care related costs (indirect), including societal costs based on days with sick-leaves (indirect). All costs are calculated in Swedish currency (SEK).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality Adjusted Life Year (QALY)</measure>
      <time_frame>From baseline until study completion at 18 months.</time_frame>
      <description>Quality Adjusted Life Year is estimated for each health state by literature search and for each of the three treatment alternatives. QALY is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). Thus, a higher value means a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cost/QALY</measure>
      <time_frame>From baseline until study completion at 18 months.</time_frame>
      <description>Cost/QALY is estimated for each health state by literature search and for each of the three treatment alternatives. Cost/QALY is illustrating the cost per disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the cost per value of medical interventions. A lower value means a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incremental Cost Efficiency Rate (ICER)</measure>
      <time_frame>From baseline until study completion at 18 months.</time_frame>
      <description>Based on glucose control cost-effect pairs is generated for Tandem Control-IQ vs. MDI respectively Tandem-Control-IQ vs. CSII. An ICER is calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome or effect (incremental effect) to provide a ratio of 'extra cost per extra unit of health effect' - for therapy A vs therapy B. A higher value means a better outcome. A prediction is added 10-, 20-, and 30-years ahead. ICER is estimated for these three time intervals.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Glucose control at start of the study</measure>
      <time_frame>At Baseline</time_frame>
      <description>In all participants, Hemoglobin A1c (HbA1c) is measured before the start of the study and comparisons are made between the three treatment groups regarding mean HbA1c and how dispersed the data is in relation to the mean (standard deviation). A lower HbA1c means a better glucose control and a lower standard deviation means less variability within the group.</description>
    </other_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">84</enrollment>
    <condition>Type 1 Diabetes</condition>
    <arm_group>
      <arm_group_label>rtCGM + MDI</arm_group_label>
      <description>Real-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>rtCGM + CSII</arm_group_label>
      <description>Real-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tandem Control-IQ</arm_group_label>
      <description>Realtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tandem Control-IQ</intervention_name>
      <description>AID-system</description>
      <arm_group_label>Tandem Control-IQ</arm_group_label>
      <arm_group_label>rtCGM + CSII</arm_group_label>
      <arm_group_label>rtCGM + MDI</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals diagnosed with Type 1 diabetes at two different pediatric diabetes centres.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 2-19 years at the start&#xD;
  &#xD;
            -  Diagnosed with Type 1 diabetes&#xD;
  &#xD;
            -  Min duration three months&#xD;
  &#xD;
            -  Willingness to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Unwillingness to share and upload CGM data&#xD;
  &#xD;
            -  Reluctance to come to visit and to follow protocol&#xD;
  &#xD;
            -  History of allergic reaction to Dexcom CGM materials or adhesives in contact with the&#xD;
               skin.&#xD;
  &#xD;
            -  Abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn,&#xD;
               inflammation, infection, rash, and/or tattoo)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>19 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Peter Adolfsson, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Västra Götalandsregionen, Gothenburg University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The hospital of Halland Kungsbacka</name>
        <address>
          <city>Kungsbacka</city>
          <state>Region Of Halland</state>
          <zip>43480</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Vastra Gotaland Region</investigator_affiliation>
      <investigator_full_name>Johan Peter Adolfsson</investigator_full_name>
      <investigator_title>Principal Investigator</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/NCT05969106
  org study id: VastraGotaland - 2022-00332-01
  nct id: NCT05969106
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  To evaluate Tandem Control-IQ compared with rtCGM and insulin pen respectively rtCGM and
        insulin pump treatment in children and adolescents regarding glucose control, sleep and
        health economics for 18 months.
  In this obesrvational study, the investigators assessed glycemic outcomes, sleep and health
        economics associated with AID treatment (Tandem Control-IQ) compared with multiple daily
        insulin injections with rtCGM (MDI+rtCGM) and a standalone insulin pump with rtCGM
        (CSII+rtCGM). Participants from two clinical sites in Sweden who continuously used one of the
        three modalities for at least six months were included in the analysis. Inclusion required
        all participants to use the Dexcom G6 rtCGM sensor for glucose monitoring, which meant only
        insulin treatment differentiated the three groups. Comparisons were conducted regarding
        Hemoglobon A1c (HbA1c) at the start of the study and rtCGM-generated glycemic metrics from 1
        month before the study started until 18 months. Sleep quality and quantity were assessed
        using a questionnaire for the persons with diabetes and the caretakers. Indirect and direct
        costs in all healthcare systems and additional information on sick leaves were collected from
        the Swedish Social Insurance Agency. Comparisons were then made between the three treatment
        alternatives.
  observational model: Case-Control
  time perspective: Prospective
  measure: Glycemic metrics
  time frame: Change from baseline to 6, 12 and 18 months
  description: Time in range (TIR), Time below range (TBR) Level 1 and 2, Time above range (TAR) Level 1 and 2, Time in tighter range (TITR)
  measure: Sleep
  time frame: At study completion at 12 months.
  description: Quantity and quality are defined in the questionnaire. Assessment by a 10-point Likert scale (1= "Worst possible", 10= "Best possible")
  measure: Costs - direct
  time frame: From baseline until study completion at 18 months
  description: Cost for the insulin administration devices and continuous glucose monitoring devices per person/year (direct). All costa are calculated in Swedish currency (SEK).
  measure: Costs - indirect
  time frame: From baseline until study completion at 18 months
  description: Cost for comorbidities and all health-care related costs (indirect), including societal costs based on days with sick-leaves (indirect). All costs are calculated in Swedish currency (SEK).
  measure: Quality Adjusted Life Year (QALY)
  time frame: From baseline until study completion at 18 months.
  description: Quality Adjusted Life Year is estimated for each health state by literature search and for each of the three treatment alternatives. QALY is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). Thus, a higher value means a better outcome.
  measure: Cost/QALY
  time frame: From baseline until study completion at 18 months.
  description: Cost/QALY is estimated for each health state by literature search and for each of the three treatment alternatives. Cost/QALY is illustrating the cost per disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the cost per value of medical interventions. A lower value means a better outcome.
  measure: Incremental Cost Efficiency Rate (ICER)
  time frame: From baseline until study completion at 18 months.
  description: Based on glucose control cost-effect pairs is generated for Tandem Control-IQ vs. MDI respectively Tandem-Control-IQ vs. CSII. An ICER is calculated by dividing the difference in total costs (incremental cost) by the difference in the chosen measure of health outcome or effect (incremental effect) to provide a ratio of 'extra cost per extra unit of health effect' - for therapy A vs therapy B. A higher value means a better outcome. A prediction is added 10-, 20-, and 30-years ahead. ICER is estimated for these three time intervals.
  measure: Glucose control at start of the study
  time frame: At Baseline
  description: In all participants, Hemoglobin A1c (HbA1c) is measured before the start of the study and comparisons are made between the three treatment groups regarding mean HbA1c and how dispersed the data is in relation to the mean (standard deviation). A lower HbA1c means a better glucose control and a lower standard deviation means less variability within the group.
  arm group label: rtCGM + MDI
  description: Real-time CGM Dexcom G6 used in parallel to Multiple Daily Injections (MDI)
  arm group label: rtCGM + CSII
  description: Real-time CGM Dexcom G6 used in parallel to freestanding Continuous Subcutaneous Insulin Infusion (CSII)
  arm group label: Tandem Control-IQ
  description: Realtime CGM Dexcom G6 used as part of the Automated Insulin Delivery (AID) system
  intervention type: Device
  intervention name: Tandem Control-IQ
  description: AID-system
  arm group label: Tandem Control-IQ
  arm group label: rtCGM + CSII
  arm group label: rtCGM + MDI
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 19 Years
  healthy volunteers: No
  last name: Peter Adolfsson, MD PhD
  role: Principal Investigator
  affiliation: Västra Götalandsregionen, Gothenburg University
  facility: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Vastra Gotaland Region
  investigator full name: Johan Peter Adolfsson
  investigator title: Principal Investigator
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No