<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/NCT03819725</url>
  </required_header>
  <id_info>
    <org_study_id>CER-VD / 2017-02090</org_study_id>
    <nct_id>NCT03819725</nct_id>
  </id_info>
  <brief_title>Monitoring of Postprandial Glycemic Variability in Healthy Young Infants</brief_title>
  <acronym>IGVM</acronym>
  <official_title>Monitoring of Postprandial Glycemic Variability in Healthy Young Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Lausanne Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Lausanne Hospitals</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To measure and quantify the postprandial glucose variations in response to a meal in the&#xD;
      healthy 6-12 months old child and correlate this response with the composition of this meal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet&#xD;
      including infant formula, solid foods such as mixed meat and vegetable preparation or&#xD;
      marketed preparations will be recruited. Children will be recruited in the Lausanne Childrens&#xD;
      hospital and only be included in the study whenin good general health.&#xD;
&#xD;
      FreeStyle® Libre Pro Interstitial Glucose Meter will be applied on the last day before&#xD;
      discharge from the hospital after skin preparation with anesthetic cream (Emla®) during&#xD;
      hospitalization and measurements will be recorded during 2-5 days.&#xD;
&#xD;
      It is not intended to measure capillary or venous blood glucose levels during this study.&#xD;
      However, if blood is collected during hospitalization, blood glucose will be measured in&#xD;
      parallel with the interstitial glucose measured with the device.&#xD;
&#xD;
      The child will follow his usual diet without modifications. The amount of food consumed by&#xD;
      the child as well as the length of the meals will be recorded by the parents. For meals made&#xD;
      by the parents they will be asked to keep a sample not seen to analyze their carbohydrate&#xD;
      content. The total carbohydrate content will be measured .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prandial glucose variations</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Change of preprandial to postprandial glucose measurements, expressed in mmol/l</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Infant Conditions</condition>
  <condition>Glucose Intolerance</condition>
  <arm_group>
    <arm_group_label>Glucose monitoring</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla® ) and glucose measurements will be monitored during 2-5 days. Oral food intake will be recorded.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Glucose monitoring</intervention_name>
    <description>FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla®) . Interstitial glucose measurements will be recorded during 2-5 days and during meals.</description>
    <arm_group_label>Glucose monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Term infants (boys and girls)&#xD;
&#xD;
          -  6 to 12 months old&#xD;
&#xD;
          -  In good general health&#xD;
&#xD;
          -  Nourished with diverse nutrition including infant formula, solid foods such as mixed&#xD;
             meat and vegetable preparation or marketed preparations&#xD;
&#xD;
          -  Infant child: if the child is breastfed partially, it can be included in the study. In&#xD;
             this case, only samples of a food supplement will be collected for evaluation of the&#xD;
             composition.&#xD;
&#xD;
          -  Hospitalized at the Lausanne Children's Hospital for non-severe reasons that do not&#xD;
             affect or suspect to affect glucose metabolism&#xD;
&#xD;
          -  Measures of feeding (time and compositions with samples) feasible for 3 consecutive&#xD;
             days by the parents at home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child born premature&#xD;
&#xD;
          -  One or both parents with type 2 diabetes or gestational diabetes&#xD;
&#xD;
          -  Child totally breastfed&#xD;
&#xD;
          -  Chronic skin condition such as eczema, excessive dryness.&#xD;
&#xD;
          -  Allergy known to adhesive plaster&#xD;
&#xD;
          -  Infectious diseases affecting the skin (eg chickenpox, scarlet fever,)&#xD;
&#xD;
          -  disorders of cutaneous microcirculation&#xD;
&#xD;
          -  Infants suffering from diseases affecting nutrition or digestion (diarrheal&#xD;
             gastroenteritis) and children undergoing antibiotic treatment that may affect&#xD;
             gastrointestinal absorption&#xD;
&#xD;
          -  Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or Diathermy Therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Hauschild, MF</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHUV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Endocrinology, Diabetology and Obesity Unit, Service of Pediatrics, Lausanne University Hospital</name>
      <address>
        <city>Lausanne</city>
        <state>Vaud</state>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>June 21, 2021</last_update_submitted>
  <last_update_submitted_qc>June 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
    <investigator_full_name>Michael Hauschild</investigator_full_name>
    <investigator_title>Dr. Michael Hauschild, MD</investigator_title>
  </responsible_party>
  <keyword>Glucose variation</keyword>
  <keyword>Infant</keyword>
  <keyword>Nutrition</keyword>
  <keyword>interstitial glucose variation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03819725
org study id: CER-VD / 2017-02090
nct id: NCT03819725
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To measure and quantify the postprandial glucose variations in response to a meal in the
      healthy 6-12 months old child and correlate this response with the composition of this meal.
14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet
      including infant formula, solid foods such as mixed meat and vegetable preparation or
      marketed preparations will be recruited. Children will be recruited in the Lausanne Childrens
      hospital and only be included in the study whenin good general health.

      FreeStyle® Libre Pro Interstitial Glucose Meter will be applied on the last day before
      discharge from the hospital after skin preparation with anesthetic cream (Emla®) during
      hospitalization and measurements will be recorded during 2-5 days.

      It is not intended to measure capillary or venous blood glucose levels during this study.
      However, if blood is collected during hospitalization, blood glucose will be measured in
      parallel with the interstitial glucose measured with the device.

      The child will follow his usual diet without modifications. The amount of food consumed by
      the child as well as the length of the meals will be recorded by the parents. For meals made
      by the parents they will be asked to keep a sample not seen to analyze their carbohydrate
      content. The total carbohydrate content will be measured .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Prandial glucose variations
time frame: up to 5 days
description: Change of preprandial to postprandial glucose measurements, expressed in mmol/l
arm group label: Glucose monitoring
arm group type: Other
description: FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla® ) and glucose measurements will be monitored during 2-5 days. Oral food intake will be recorded.
intervention type: Device
intervention name: Glucose monitoring
description: FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla®) . Interstitial glucose measurements will be recorded during 2-5 days and during meals.
arm group label: Glucose monitoring
criteria: 
gender: All
minimum age: 6 Months
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Hauschild, MF
role: Principal Investigator
affiliation: CHUV
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Lausanne Hospitals
investigator full name: Michael Hauschild
investigator title: Dr. Michael Hauschild, MD
mesh term: Glucose Intolerance
sharing ipd: Undecided