<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/NCT03293082</url>
  </required_header>
  <id_info>
    <org_study_id>CGM-GV-Preschool- SI-01</org_study_id>
    <nct_id>NCT03293082</nct_id>
  </id_info>
  <brief_title>Preschool CGM Use and Glucose Variability in Type 1 Diabetes</brief_title>
  <official_title>The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ljubljana, Faculty of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Ljubljana, Faculty of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this clinical study is to evaluate the efficacy continuous glucose&#xD;
      monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with&#xD;
      CSII.&#xD;
&#xD;
      Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed&#xD;
      for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other&#xD;
      glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG&#xD;
      data) and compared to periods when CGM was not used (SMBG only data).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Glucose variability</measure>
    <time_frame>Three years</time_frame>
    <description>Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean intersticial glucose</measure>
    <time_frame>Three years</time_frame>
    <description>Mean glucose as measured with CGM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean blood glucose</measure>
    <time_frame>Three years</time_frame>
    <description>Mean glucose as measured with SMBG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>Three years</time_frame>
    <description>glycosilated hemoglobin</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CGM ON</intervention_name>
    <description>The period of time when continuous glucose monitoring was used, in edition to SMBG</description>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CGM OFF</intervention_name>
    <description>The period of time when continuous glucose monitoring was not used, only SMBG</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population of preschool children with type 1 diabetes aged up to 7 years that were&#xD;
        prescribed sensor use in the observational period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject with Type 1 diabetes (&amp;gt; 6 months since diagnosis)&#xD;
&#xD;
          2. Insulin infusion pump CSII therapy for at least 3 months&#xD;
&#xD;
          3. Age ≤ 7 years&#xD;
&#xD;
          4. HbA1c at inclusion ≥ 6.5 and &lt; 10&#xD;
&#xD;
          5. BMI SDS - below the 95th percentile for age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Concomitant diseases that influence metabolic control&#xD;
&#xD;
          2. Participation in any other interventional study&#xD;
&#xD;
          3. Known or suspected allergy to trial products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>7 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>UMC - University Children's Hospital Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</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>
  <!-- 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/NCT03293082
org study id: CGM-GV-Preschool- SI-01
nct id: NCT03293082
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objectives of this clinical study is to evaluate the efficacy continuous glucose
      monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with
      CSII.

      Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed
      for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other
      glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG
      data) and compared to periods when CGM was not used (SMBG only data).
observational model: Cohort
time perspective: Cross-Sectional
measure: Glucose variability
time frame: Three years
description: Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose
measure: Mean intersticial glucose
time frame: Three years
description: Mean glucose as measured with CGM
measure: Mean blood glucose
time frame: Three years
description: Mean glucose as measured with SMBG
measure: HbA1c
time frame: Three years
description: glycosilated hemoglobin
intervention type: Device
intervention name: CGM ON
description: The period of time when continuous glucose monitoring was used, in edition to SMBG
intervention type: Device
intervention name: CGM OFF
description: The period of time when continuous glucose monitoring was not used, only SMBG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 7 Years
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1