<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/NCT03804658</url>
  </required_header>
  <id_info>
    <org_study_id>CG18308A</org_study_id>
    <nct_id>NCT03804658</nct_id>
  </id_info>
  <brief_title>The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes</brief_title>
  <official_title>The Effects of Glucose Monitor on Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taichung Veterans General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taichung Veterans General Hospital</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>
      To assess the effect of glucose monitors on glucose control and cardiovascular risks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will enroll patients with diabetes. The answered questionnaire and blood&#xD;
      samples will be collected at baseline. After change the methods or frequency of glucose&#xD;
      monitor, the blood samples will be collected again. The investigators will analyze the&#xD;
      factors which may affect the glucose control after changes in methods of glucose monitor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 13, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Glucose variability</measure>
    <time_frame>3 months</time_frame>
    <description>Data from continue glucose monitor system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>brain-derived neurotrophic factor</measure>
    <time_frame>3 months</time_frame>
    <description>Biomarker of cognition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orexin</measure>
    <time_frame>3 months</time_frame>
    <description>Biomarker of cognition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renalase</measure>
    <time_frame>3 months</time_frame>
    <description>Biomarker of cognition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular endothelial cell adhesion molecule 1</measure>
    <time_frame>3 months</time_frame>
    <description>Biomarker for inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Literacy</measure>
    <time_frame>3 months</time_frame>
    <description>Questionnaire of health</description>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Glucose Variability</condition>
  <condition>Cognitive Decline</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continue glucose monitor system</intervention_name>
    <description>The cardiovascular risks and data from continue glucose monitor system</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, Plasma and urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with diabetes both in outpatient and inpatient&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incooperative patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>I-Te Lee, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taichung Veterans General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>I-Te Lee, MD,PhD</last_name>
    <phone>+886-4-23592525</phone>
    <phone_ext>4006</phone_ext>
    <email>itlee@vghtc.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Endocrinology and Metabolism in Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>407</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>I-Te Lee, MD</last_name>
      <phone>886-4-23741340</phone>
      <email>itlee@vghtc.gov.tw</email>
    </contact>
    <investigator>
      <last_name>I-Te Lee, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>October 18, 2020</last_update_submitted>
  <last_update_submitted_qc>October 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain-derived neurotrophic factor</keyword>
  <keyword>Vascular cell adhesion molecule 1</keyword>
  <keyword>Renalase</keyword>
  <keyword>Orexin</keyword>
  <keyword>Continue glucose monitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not to share individual participant data</ipd_description>
  </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/NCT03804658
org study id: CG18308A
nct id: NCT03804658
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the effect of glucose monitors on glucose control and cardiovascular risks.
The investigators will enroll patients with diabetes. The answered questionnaire and blood
      samples will be collected at baseline. After change the methods or frequency of glucose
      monitor, the blood samples will be collected again. The investigators will analyze the
      factors which may affect the glucose control after changes in methods of glucose monitor.
observational model: Cohort
time perspective: Prospective
measure: Glucose variability
time frame: 3 months
description: Data from continue glucose monitor system
measure: brain-derived neurotrophic factor
time frame: 3 months
description: Biomarker of cognition
measure: Orexin
time frame: 3 months
description: Biomarker of cognition
measure: Renalase
time frame: 3 months
description: Biomarker of cognition
measure: Vascular endothelial cell adhesion molecule 1
time frame: 3 months
description: Biomarker for inflammation
measure: Health Literacy
time frame: 3 months
description: Questionnaire of health
intervention type: Device
intervention name: Continue glucose monitor system
description: The cardiovascular risks and data from continue glucose monitor system
Serum, Plasma and urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: I-Te Lee, MD,PhD
role: Principal Investigator
affiliation: Taichung Veterans General Hospital
last name: I-Te Lee, MD,PhD
phone: +886-4-23592525
phone ext: 4006
email: itlee@vghtc.gov.tw
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: Not to share individual participant data