<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/NCT03037671</url>
  </required_header>
  <id_info>
    <org_study_id>16-2250.cc</org_study_id>
    <nct_id>NCT03037671</nct_id>
  </id_info>
  <brief_title>Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric HSCT Population</brief_title>
  <official_title>Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</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>
      This study is designed to determine feasibility of using a continuous glucose monitor in&#xD;
      pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients,&#xD;
      and to identify the incidence and risk factors for malglycemia in primary admission for&#xD;
      pediatric, adolescent and young adult HSCT patients as well as to characterize the&#xD;
      relationship between outcomes and malglycemia in this population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective observational cohort analysis examining the rate of malglycemia&#xD;
      in the pediatric HSCT population and the effect of malglycemia on important post-HSCT&#xD;
      outcomes. In addition to usual care during the peri-HSCT period, participants in this trial&#xD;
      will be asked to wear a continuous glucose monitor for the duration of their initial hospital&#xD;
      admission. Participants will wear this monitor while admitted to the hospital for up to one&#xD;
      week prior to transplant, and up to 60 days after transplant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Anticipated">January 2024</completion_date>
  <primary_completion_date type="Actual">January 17, 2020</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>The number of patients with Malgylcemia</measure>
    <time_frame>1 week prior to transplant through maximum 60 days post-transplant; inpatient only</time_frame>
    <description>Hypoglycemia (BG &lt; 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL). Participants will wear a continous glucose monitor (CGM) to measure glycemia levels. This will service both as an exposure and and outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number patients that contract an infection</measure>
    <time_frame>0-100 days post-transplant</time_frame>
    <description>Infection, defined by clinically significant positive microbiology or radiology result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The length of hospital stays for all participants</measure>
    <time_frame>Through study completion to 1 year of follow-up</time_frame>
    <description>Days in the hospital post-transplant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The length of hospital stays in the ICU for all participants</measure>
    <time_frame>Through study completion to 1 year of follow-up</time_frame>
    <description>Number of days in the intensive care unit (ICU) during primary HSCT admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Graft-versus-host-disease (GVHD) status of all participants</measure>
    <time_frame>Through study completion to 1 year of follow-up</time_frame>
    <description>Graft-versus-host status and time to graft-versus-host will be analyzed</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>CGM Monitored Cohort</arm_group_label>
    <description>The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitor (CGM)</intervention_name>
    <description>Participants will wear the continuous glucose monitor (GCM) device during the peri-HSCT period for the duration of their initial hospital admission. No intervention based on results.</description>
    <arm_group_label>CGM Monitored Cohort</arm_group_label>
    <other_name>Abbot Freestyle Libre Pro</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will enroll 23-30 subjects undergoing hematopoietic stem cell transplant at&#xD;
        Children's Hospital Colorado.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients age 2 to 30 years old at time of transplant.&#xD;
&#xD;
          2. Patients undergoing hematopoietic stem cell transplantation at CHCO.&#xD;
&#xD;
          3. Subject willing to wear a continuous glucose monitor for the duration of the study.&#xD;
&#xD;
          4. Subject willing to follow study protocols.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Preexisting diagnosis of type 1 diabetes, type 2 diabetes, or an insulin requirement&#xD;
             in the 2 weeks preceding transplant.&#xD;
&#xD;
          2. Preexisting condition requiring use of steroids (other than HSCT)&#xD;
&#xD;
          3. Severe psychiatric disease or developmental delays that might interfere with ability&#xD;
             to provide informed consent.&#xD;
&#xD;
          4. Any other medical condition which in the opinion of the investigators impairs the&#xD;
             person's ability to safely participate in the trial.&#xD;
&#xD;
          5. Subject has an active skin condition that would affect sensor placement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenna M Sopfe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Colorado</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malglycemia</keyword>
  <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/NCT03037671
org study id: 16-2250.cc
nct id: NCT03037671
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is designed to determine feasibility of using a continuous glucose monitor in
      pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients,
      and to identify the incidence and risk factors for malglycemia in primary admission for
      pediatric, adolescent and young adult HSCT patients as well as to characterize the
      relationship between outcomes and malglycemia in this population.
This study is a prospective observational cohort analysis examining the rate of malglycemia
      in the pediatric HSCT population and the effect of malglycemia on important post-HSCT
      outcomes. In addition to usual care during the peri-HSCT period, participants in this trial
      will be asked to wear a continuous glucose monitor for the duration of their initial hospital
      admission. Participants will wear this monitor while admitted to the hospital for up to one
      week prior to transplant, and up to 60 days after transplant.
observational model: Cohort
time perspective: Prospective
measure: The number of patients with Malgylcemia
time frame: 1 week prior to transplant through maximum 60 days post-transplant; inpatient only
description: Hypoglycemia (BG < 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL). Participants will wear a continous glucose monitor (CGM) to measure glycemia levels. This will service both as an exposure and and outcome.
measure: The number patients that contract an infection
time frame: 0-100 days post-transplant
description: Infection, defined by clinically significant positive microbiology or radiology result
measure: The length of hospital stays for all participants
time frame: Through study completion to 1 year of follow-up
description: Days in the hospital post-transplant
measure: The length of hospital stays in the ICU for all participants
time frame: Through study completion to 1 year of follow-up
description: Number of days in the intensive care unit (ICU) during primary HSCT admission
measure: The Graft-versus-host-disease (GVHD) status of all participants
time frame: Through study completion to 1 year of follow-up
description: Graft-versus-host status and time to graft-versus-host will be analyzed
arm group label: CGM Monitored Cohort
description: The continuous glucose monitor (CGM) used during this study will be the Abbot Freestyle Libre Professional Continuous Glucose Monitoring System.
intervention type: Device
intervention name: Continuous Glucose Monitor (CGM)
description: Participants will wear the continuous glucose monitor (GCM) device during the peri-HSCT period for the duration of their initial hospital admission. No intervention based on results.
arm group label: CGM Monitored Cohort
other name: Abbot Freestyle Libre Pro
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 30 Years
healthy volunteers: No
last name: Jenna M Sopfe, MD
role: Principal Investigator
affiliation: Children's Hospital Colorado
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No