<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/NCT04458649</url>
  </required_header>
  <id_info>
    <org_study_id>191263</org_study_id>
    <nct_id>NCT04458649</nct_id>
  </id_info>
  <brief_title>Continuous Glucose Monitoring in Infants</brief_title>
  <official_title>Continuous Glucose Monitoring in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to employ continuous glucose monitoring to measure glucose&#xD;
      profiles in newborn infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will place a continuous glucose monitor on the infant within 2 hours of birth and record&#xD;
      blood glucose values every 5 minutes via the monitor; in addition, the infant will receive&#xD;
      blood glucose checks via heel stick according to the standard hospital glucose monitoring&#xD;
      protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 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>Time spent with glucose &lt;40 mg/dL</measure>
    <time_frame>The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.</time_frame>
    <description>The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as &lt;40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of &lt;40 mg/dL.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Neonatal Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>No increased risk of hypoglycemia</arm_group_label>
    <description>Infants born with no obvious risk factors for hypoglycemia in the neonatal period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Increased risk of hypoglycemia</arm_group_label>
    <description>Infants considered at increased risk for hypoglycemia after birth including the following criteria:&#xD;
Infant born to a diabetic mother&#xD;
Very large for gestational age (VLGA) infant with weight &gt;97%</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom continuous glucose monitor</intervention_name>
    <description>Measurement of interstitial glucose</description>
    <arm_group_label>Increased risk of hypoglycemia</arm_group_label>
    <arm_group_label>No increased risk of hypoglycemia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and&#xD;
        postpartum care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mother at least 18 years of age&#xD;
&#xD;
          -  Infants born either appropriate for gestational age (AGA) or large for gestational age&#xD;
             (LGA)&#xD;
&#xD;
          -  Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin&#xD;
             calipers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants born small for gestational age (SGA)&#xD;
&#xD;
          -  Infant birth weight &lt;2.5 kg&#xD;
&#xD;
          -  Infant BMI &lt;10th percentile on Olsen chart&#xD;
&#xD;
          -  Infants born &lt;38 weeks gestation&#xD;
&#xD;
          -  Infants with concern for intrauterine growth restriction (IUGR) and short femur length&#xD;
             based on ultrasound&#xD;
&#xD;
          -  Mother is non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Hour</minimum_age>
    <maximum_age>2 Hours</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jane Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California San Diego/Rady Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Valentina Stanley, BS</last_name>
    <phone>(858) 249-5985</phone>
    <email>vstanley@health.ucsd.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jane Kim, MD</last_name>
    <phone>(858) 966-4032</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UCSD Medical Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valentina Stanley, BS</last_name>
      <phone>858-966-4032</phone>
      <email>vstanley@health.ucsd.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jane Kim, MD</last_name>
      <phone>858-966-4032</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.</citation>
    <PMID>28364046</PMID>
  </reference>
  <reference>
    <citation>Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319.</citation>
    <PMID>26780301</PMID>
  </reference>
  <reference>
    <citation>Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061.</citation>
    <PMID>19952738</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Dr Jane Kim</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoglycemia</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/NCT04458649
org study id: 191263
nct id: NCT04458649
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to employ continuous glucose monitoring to measure glucose
      profiles in newborn infants.
We will place a continuous glucose monitor on the infant within 2 hours of birth and record
      blood glucose values every 5 minutes via the monitor; in addition, the infant will receive
      blood glucose checks via heel stick according to the standard hospital glucose monitoring
      protocol.
observational model: Cohort
time perspective: Prospective
measure: Time spent with glucose <40 mg/dL
time frame: The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.
description: The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as <40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of <40 mg/dL.
arm group label: No increased risk of hypoglycemia
description: Infants born with no obvious risk factors for hypoglycemia in the neonatal period.
arm group label: Increased risk of hypoglycemia
description: Infants considered at increased risk for hypoglycemia after birth including the following criteria:
Infant born to a diabetic mother
Very large for gestational age (VLGA) infant with weight >97%
intervention type: Device
intervention name: Dexcom continuous glucose monitor
description: Measurement of interstitial glucose
arm group label: Increased risk of hypoglycemia
arm group label: No increased risk of hypoglycemia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Hour
maximum age: 2 Hours
healthy volunteers: Accepts Healthy Volunteers
last name: Jane Kim, MD
role: Principal Investigator
affiliation: University of California San Diego/Rady Children's Hospital
last name: Valentina Stanley, BS
phone: (858) 249-5985
email: vstanley@health.ucsd.edu
last name: Jane Kim, MD
phone: (858) 966-4032
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Thompson-Branch A, Havranek T. Neonatal Hypoglycemia. Pediatr Rev. 2017 Apr;38(4):147-157. doi: 10.1542/pir.2016-0063.
PMID: 28364046
citation: Adamkin DH. Neonatal hypoglycemia. Curr Opin Pediatr. 2016 Apr;28(2):150-5. doi: 10.1097/MOP.0000000000000319.
PMID: 26780301
citation: Straussman S, Levitsky LL. Neonatal hypoglycemia. Curr Opin Endocrinol Diabetes Obes. 2010 Feb;17(1):20-4. doi: 10.1097/MED.0b013e328334f061.
PMID: 19952738
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Dr Jane Kim
investigator title: Professor of Pediatrics
mesh term: Hypoglycemia
sharing ipd: No