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/NCT06018324</url>
    </required_header>
    <id_info>
      <org_study_id>DIA-2023-01</org_study_id>
      <nct_id>NCT06018324</nct_id>
    </id_info>
    <brief_title>CloudCare in the Treatment of Type 1 Diabetes in Pediatrics</brief_title>
    <official_title>CloudCare Patient Reported Outcomes in the Treatment of Type 1 Diabetes in Pediatrics A Prospective Cohort Study in Europe</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Diabeter Nederland BV</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Diabeter Nederland BV</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective cohort study aims to estimate the effect of the CloudCare application in&#xD;
        daily practice on treatment satisfaction and emotional burden for pediatric patients and&#xD;
        their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional&#xD;
        satisfaction, and the impact on costs.&#xD;
  &#xD;
        A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the&#xD;
        study.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi center prospective cohort study in Europe with pre- and post-measurements in&#xD;
        type 1 diabetes with 12 months follow-up. This study will only include pediatric patients for&#xD;
        which CloudCare is part of their (new) standard care of type 1 diabetes. Participants will be&#xD;
        enrolled in several hospitals/healthcare organisations in Europe. Participant's data will be&#xD;
        retrieved from their medical records and from uploaded data of their medical devices used for&#xD;
        their type 1 diabetes treatment.&#xD;
  &#xD;
        The study will consist of two periods. A 3 months' retrospective period in which data will be&#xD;
        retrieved from patients' dossier followed by a 12 months' prospective period after&#xD;
        introduction of CloudCare as part of patients' standard care by the treating physician.&#xD;
  &#xD;
        The 3 months' retrospective period is the control period for the prospective period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>DTSQc</measure>
      <time_frame>6 months</time_frame>
      <description>Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>DTSQs</measure>
      <time_frame>0, 6, 12 months</time_frame>
      <description>Change in mean treatment satisfaction score at 0- 6- and 12-months using status version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) for Teens and Parents</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean % HbA1c</measure>
      <time_frame>-3 months to 3, 6 and 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean TIR</measure>
      <time_frame>-3 months to 3, 6 and 12 months</time_frame>
      <description>Time in Range</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean TAR</measure>
      <time_frame>-3 months to 3, 6 and 12 months</time_frame>
      <description>Time Above Range</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean TBR</measure>
      <time_frame>-3 months to 3, 6 and 12 months</time_frame>
      <description>Time Below Range</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean PAID-teens and PAID-parent</measure>
      <time_frame>0, 3, 6 and 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean QoL score and mean QoL diabetes related score</measure>
      <time_frame>0, 3, 6 and 12 months</time_frame>
      <description>Quality of Life; 2 questions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire</measure>
      <time_frame>0, 3, 6 and 12 months</time_frame>
      <description>Non-validated satisfaction questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment costs</measure>
      <time_frame>0, 3, 6 and 12 months</time_frame>
      <description>Treatment costs of complications requiring hospitalizations&#xD;
  Number of contacts with HCP&#xD;
  Type of contacts with HCP (Face to face, Email/Telephone)&#xD;
  Time spent by the HCP</description>
    </secondary_outcome>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Type1diabetes</condition>
    <condition>Pediatric ALL</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric patients with type 1 diabetes (1-15 years). All participants must be treated with&#xD;
          multiple daily injections of insulin (MDI) or continuous subcutaneous insulin infusion&#xD;
          (CSII) with continuous or flash glucose monitoring (CGM/FGM) for at least three months&#xD;
          without CloudCare and will get CloudCare as part of their standard care.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Parents/caregivers and, depending on local laws and regulations, also the patient are&#xD;
               willing to sign the study informed consent form prior to any data collection for this&#xD;
               study&#xD;
  &#xD;
            -  Clinical diagnosis, based on investigator assessment, of type 1 diabetes and using&#xD;
               insulin with or without metformin for at least 6 months.&#xD;
  &#xD;
            -  Age between 1 and 15 years old.&#xD;
  &#xD;
            -  Use of multiple daily injections of insulin (MDI, with a basal insulin injection and&#xD;
               bolus injections) or continuous subcutaneous insulin infusion (CSII) with Flash or&#xD;
               Continuous Glucose Monitoring (FGM/CGM), but without CloudCare for at least three&#xD;
               months.&#xD;
  &#xD;
            -  Receiving CloudCare as part of their standard care for at least 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with type 1 diabetes on glucose lowering treatments other than insulin with&#xD;
               or without metformin.&#xD;
  &#xD;
            -  Any known factor, condition, or disease that might interfere with study conduct or&#xD;
               interpretation of the results, as deemed by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Henk-Jan Aanstoot, MD, PhD</last_name>
      <phone>+0031 620372667</phone>
      <email>h.j.aanstoot@diabeter.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Diabeter</name>
        <address>
          <city>Rotterdam</city>
          <state>Zuid-Holland</state>
          <zip>3011 TA</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06018324
  org study id: DIA-2023-01
  nct id: NCT06018324
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This prospective cohort study aims to estimate the effect of the CloudCare application in
        daily practice on treatment satisfaction and emotional burden for pediatric patients and
        their parents/caregivers, patients' glycemic control (glucometrics), healthcare professional
        satisfaction, and the impact on costs.
  
        A total of 600 pediatric patients (1-15 years) with type 1 diabetes will be enrolled into the
        study.
  This is a multi center prospective cohort study in Europe with pre- and post-measurements in
        type 1 diabetes with 12 months follow-up. This study will only include pediatric patients for
        which CloudCare is part of their (new) standard care of type 1 diabetes. Participants will be
        enrolled in several hospitals/healthcare organisations in Europe. Participant's data will be
        retrieved from their medical records and from uploaded data of their medical devices used for
        their type 1 diabetes treatment.
  
        The study will consist of two periods. A 3 months' retrospective period in which data will be
        retrieved from patients' dossier followed by a 12 months' prospective period after
        introduction of CloudCare as part of patients' standard care by the treating physician.
  
        The 3 months' retrospective period is the control period for the prospective period.
  observational model: Cohort
  time perspective: Prospective
  measure: DTSQc
  time frame: 6 months
  description: Change in mean treatment satisfaction score at 6 months using change version of the Diabetes Treatment Satisfaction Questionnaire (DTSQc) for Teens and Parents
  measure: DTSQs
  time frame: 0, 6, 12 months
  description: Change in mean treatment satisfaction score at 0- 6- and 12-months using status version of the Diabetes Treatment Satisfaction Questionnaire (DTSQs) for Teens and Parents
  measure: Change in mean % HbA1c
  time frame: -3 months to 3, 6 and 12 months
  measure: Change in mean TIR
  time frame: -3 months to 3, 6 and 12 months
  description: Time in Range
  measure: Change in mean TAR
  time frame: -3 months to 3, 6 and 12 months
  description: Time Above Range
  measure: Change in mean TBR
  time frame: -3 months to 3, 6 and 12 months
  description: Time Below Range
  measure: Change in mean PAID-teens and PAID-parent
  time frame: 0, 3, 6 and 12 months
  measure: Change in mean QoL score and mean QoL diabetes related score
  time frame: 0, 3, 6 and 12 months
  description: Quality of Life; 2 questions
  measure: Change in mean treatment satisfaction score of the HCP satisfaction Questionnaire
  time frame: 0, 3, 6 and 12 months
  description: Non-validated satisfaction questionnaire
  measure: Treatment costs
  time frame: 0, 3, 6 and 12 months
  description: Treatment costs of complications requiring hospitalizations
  Number of contacts with HCP
  Type of contacts with HCP (Face to face, Email/Telephone)
  Time spent by the HCP
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 15 Years
  healthy volunteers: No
  last name: Henk-Jan Aanstoot, MD, PhD
  phone: +0031 620372667
  email: h.j.aanstoot@diabeter.nl
  facility: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: Undecided