<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/NCT03235934</url>
  </required_header>
  <id_info>
    <org_study_id>15-9329</org_study_id>
    <nct_id>NCT03235934</nct_id>
  </id_info>
  <brief_title>Glycemic Impact on Glioblastoma Outcomes</brief_title>
  <official_title>Glycemic Impact on Glioblastoma Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sinai Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</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 pilot study aims to evaluate the feasibility of close glucose monitoring and management&#xD;
      of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art&#xD;
      flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized&#xD;
      based on individual blood glucose levels. Although the glycemic interventions used in this&#xD;
      study include standard medications and methods of glucose monitoring used for patients with&#xD;
      diabetes, this pilot study will specifically evaluate the feasibility of using these&#xD;
      approaches in patients with GBM, appreciating their additional medical, functional and social&#xD;
      challenges.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this pilot study is to determine the feasibility of using close monitoring and&#xD;
      management of glucose levels in patients undergoing radiation and chemotherapy for&#xD;
      glioblastoma.&#xD;
&#xD;
      The glucose management will include the use of standard metformin a common treatment for&#xD;
      patients with early type 2 diabetes that has also shown anti-tumor effects in GBM, and will&#xD;
      be further personalized based on individual blood glucose levels. Additional&#xD;
      anti-hyperglycemic management will be provided at the discretion of the Endocrinologist.&#xD;
&#xD;
      Close glucose monitoring will include flash glucose monitoring (FGM) with a device called an&#xD;
      FreeStyle Libre Pro Flash Glucose Monitoring System, finger-prick glucose measures (standard&#xD;
      approach for patients with diabetes) and weekly blood tests (our current standard for&#xD;
      patients with GBM).&#xD;
&#xD;
      In addition to determining the feasibility of using these approaches, this pilot study will&#xD;
      help identify the simplest and most effective approach of managing glucose levels in patients&#xD;
      with GBM appreciating their additional medical, functional and social challenges.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Logistical Issues&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2018</start_date>
  <completion_date type="Actual">January 24, 2020</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</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>Total time spent in target glucose level</measure>
    <time_frame>1 week</time_frame>
    <description>total time spent in target range of 4-10 mmol/L based on FGM data during week 6 of radiotherapy and temozolomide therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the curve for glycemic exposure and variability</measure>
    <time_frame>baseline, week 1, 2, 3, 4, 5, 6, 10-13, 3 months</time_frame>
    <description>Glucose levels measured using FGM vs conventional clinical measures (e.g. capillary blood glucose)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive Function</measure>
    <time_frame>Baseline</time_frame>
    <description>To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive Function</measure>
    <time_frame>After week 10 and before week 13</time_frame>
    <description>To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive Function</measure>
    <time_frame>3 month follow up visit</time_frame>
    <description>To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prevalence of sensor site problems</measure>
    <time_frame>From baseline to week 6 - the time from sensor insertion through completion of study intervention</time_frame>
    <description>infection, irritation, and secondary complication in the study cohort</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Glioblastoma Multiforme</condition>
  <condition>Hyperglycemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who are newly diagnosed with glioblastoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (&gt; 18 years old) with a new histologically-confirmed diagnosis of&#xD;
             glioblastoma who are planned to receive a 6-week course of concurrent radiation and&#xD;
             temozolomide&#xD;
&#xD;
          -  Has evidence of random glucose of at least 7.8 mmol/L or fasting blood glucose of at&#xD;
             least 6.1 mmol/L (meeting criteria for oral diabetic medications)&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Able to understand and follow instructions regarding self-administered capillary&#xD;
             glucose measurements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI with gadolinium&#xD;
&#xD;
          -  Taking anti-hyperglycemic medications at the time of study eligibility screen&#xD;
&#xD;
          -  Unable to participate in neurocognitive evaluation in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>October 21, 2021</last_update_submitted>
  <last_update_submitted_qc>October 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glucose monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Hyperglycemia</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/NCT03235934
org study id: 15-9329
nct id: NCT03235934
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study aims to evaluate the feasibility of close glucose monitoring and management
      of patients (targeting fasting and pre-meal glucose of 4-7 mmol/L) using state-of-the-art
      flash glucose monitoring (FGM) technology. The glycemic intervention will be personalized
      based on individual blood glucose levels. Although the glycemic interventions used in this
      study include standard medications and methods of glucose monitoring used for patients with
      diabetes, this pilot study will specifically evaluate the feasibility of using these
      approaches in patients with GBM, appreciating their additional medical, functional and social
      challenges.
The purpose of this pilot study is to determine the feasibility of using close monitoring and
      management of glucose levels in patients undergoing radiation and chemotherapy for
      glioblastoma.

      The glucose management will include the use of standard metformin a common treatment for
      patients with early type 2 diabetes that has also shown anti-tumor effects in GBM, and will
      be further personalized based on individual blood glucose levels. Additional
      anti-hyperglycemic management will be provided at the discretion of the Endocrinologist.

      Close glucose monitoring will include flash glucose monitoring (FGM) with a device called an
      FreeStyle Libre Pro Flash Glucose Monitoring System, finger-prick glucose measures (standard
      approach for patients with diabetes) and weekly blood tests (our current standard for
      patients with GBM).

      In addition to determining the feasibility of using these approaches, this pilot study will
      help identify the simplest and most effective approach of managing glucose levels in patients
      with GBM appreciating their additional medical, functional and social challenges.
observational model: Cohort
time perspective: Prospective
measure: Total time spent in target glucose level
time frame: 1 week
description: total time spent in target range of 4-10 mmol/L based on FGM data during week 6 of radiotherapy and temozolomide therapy
measure: Area under the curve for glycemic exposure and variability
time frame: baseline, week 1, 2, 3, 4, 5, 6, 10-13, 3 months
description: Glucose levels measured using FGM vs conventional clinical measures (e.g. capillary blood glucose)
measure: Neurocognitive Function
time frame: Baseline
description: To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests
measure: Neurocognitive Function
time frame: After week 10 and before week 13
description: To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests
measure: Neurocognitive Function
time frame: 3 month follow up visit
description: To explore the association between glycemia and neurocognitive functions patients will undergo standardized tests
measure: prevalence of sensor site problems
time frame: From baseline to week 6 - the time from sensor insertion through completion of study intervention
description: infection, irritation, and secondary complication in the study cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Hyperglycemia
sharing ipd: No