<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/NCT03794934</url>
  </required_header>
  <id_info>
    <org_study_id>2018-12-108</org_study_id>
    <nct_id>NCT03794934</nct_id>
  </id_info>
  <brief_title>Structured Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus</brief_title>
  <acronym>Education</acronym>
  <official_title>Development and Efficacy of Individualized Professional Education Based on New Glucose Management Devices in Patients With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</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>
      Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved&#xD;
      and highly recommended in the treatment of type 1 diabetes patients worldwide, and related&#xD;
      technology development and market are growing rapidly.&#xD;
&#xD;
      In order to maximize the medical and socioeconomic effects of the latest blood glucose&#xD;
      devices including CGM and insulin pump, structured education is necessary. In this study, we&#xD;
      will develop patient-oriented structured education for patients with type 1 diabetes mellitus&#xD;
      when applying CGM, and we will assess the efficacy of this education protocol for patients&#xD;
      with type 1 diabetes using CGM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose&#xD;
      level is not well controlled, and who are undergoing multiple daily insulin injection therapy&#xD;
      or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal&#xD;
      continuous glucose levels for 1 week (window period of 2 week).&#xD;
&#xD;
      These 50 patients are 1:1 randomly assigned to 2 groups including control group and&#xD;
      intervention group. Control group (n=25) applied CGM without structured education and after 3&#xD;
      months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and&#xD;
      other glycometabolic parameters are collected. As a sequential extension clinical trial,&#xD;
      those 25 patients in control group are provided structured education, followed by applying&#xD;
      CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and&#xD;
      other glycometabolic parameters are collected.&#xD;
&#xD;
      In Intervention group (n=25), structured education program is provided for each patient from&#xD;
      the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for&#xD;
      2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>CGM apply followed by structured education of CGM</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of time in target range 70-180 mg/dL</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in level 2 hypoglycemia (&lt;54mg/dL)</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Percentage of time in level 2 hypoglycemia (&lt;54mg/dL) by continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in level 1 hypoglycemia (&lt;70-54mg/dL)</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Percentage of time in level 1 hypoglycemia (&lt;70-54mg/dL) by continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in level 1 hyperglycemia (&gt;180mg/dL)</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Percentage of time in level 1 hyperglycemia (&gt;180mg/dL) by continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in level 2 hyperglycemia (&gt;250mg/dL)</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Percentage of time in level 2 hyperglycemia (&gt;250mg/dL) by continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability, reported as coefficient of variance (CV)</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability, reported as standard deviation (SD)</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean glucose by continuous glucose monitoring system</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Mean glucose by continuous glucose monitoring system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1C</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>HbA1C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>glycated albumin</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>glycated albumin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personalized education time for each patient</measure>
    <time_frame>baseline (intervention group) and 3months (for extension study in control group)</time_frame>
    <description>Personalized education time for each patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of hypoglycemia</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Frequency of hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>3months (control and intervention groups) and 6months (for extension study in control group)</time_frame>
    <description>Adverse event occurred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of time in target range 70-180 mg/dL</measure>
    <time_frame>6months (for extension study in control group)</time_frame>
    <description>Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Without structured education when applying CGM for 3months, and as a sequential extension clinical trial, after 3 months, structured education is provided, followed by CGM apply</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>provide structured education when applying CGM for 3 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured Education for new glucose management devices</intervention_name>
    <description>Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old - under 70 years old patients with Type 1 diabetes&#xD;
&#xD;
          -  Those who plan to use CGM G5&#xD;
&#xD;
          -  Patients who consented to use CGM G5 in conjunction with Clarity&#xD;
&#xD;
          -  Those who are using multiple insulin injections or insulin pumps for at least 3 months&#xD;
&#xD;
          -  Those whose fasting c-peptide &lt;0.6 ng / dL, or stimulated c-peptide &lt;1.8 ng / dL&#xD;
&#xD;
          -  Those with a glycated hemoglobin of 7.0% or more within the last 3 months&#xD;
&#xD;
          -  Those who have never used a CGM for more than a month&#xD;
&#xD;
          -  For women of childbearing age, those who agree to use appropriate contraception during&#xD;
             the trial&#xD;
&#xD;
          -  Those who voluntarily signed the agreement after the explanation of the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with a history of severe hypoglycemia and acute ketoacidosis within the last 3&#xD;
             months&#xD;
&#xD;
          -  Patients with chronic renal function greater than or equal to stage 4 (estimated&#xD;
             glomerular filtration rate [assessed by MDRD (modification of diet in renal disease]&#xD;
             &lt;30 )&#xD;
&#xD;
          -  Patients with acute myocardial infarction, unstable angina, coronary artery disease or&#xD;
             stroke within the last 3 months&#xD;
&#xD;
          -  Patients with adrenal insufficiency, pituitary dysfunction, medically uncontrolled&#xD;
             hyperthyroidism or hypothyroidism&#xD;
&#xD;
          -  Those taking medications that can affect the glucose metabolism (eg, corticosteroids,&#xD;
             immunostimulants, etc.)&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  A person who is deemed unsuitable for participation in clinical trials by examiners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jae Hyeon Kim, MD PhD</last_name>
    <phone>82-2-3410-3439</phone>
    <email>jaehyeonmd.kim@samsung.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae Hyeon Kim, M.D.,Ph. D</last_name>
      <phone>82-2-3410-1580</phone>
      <email>jaehyeonmd.kim@samsung.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Jae Hyeon Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Type 1 Diabetes Mellitus</keyword>
  <keyword>Continuous Glucose Monitoring</keyword>
  <keyword>Insulin pump</keyword>
  <keyword>Structured Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</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/NCT03794934
org study id: 2018-12-108
nct id: NCT03794934
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Continuous glucose monitoring (CGM) and insulin pump, a new medical device, have been proved
      and highly recommended in the treatment of type 1 diabetes patients worldwide, and related
      technology development and market are growing rapidly.

      In order to maximize the medical and socioeconomic effects of the latest blood glucose
      devices including CGM and insulin pump, structured education is necessary. In this study, we
      will develop patient-oriented structured education for patients with type 1 diabetes mellitus
      when applying CGM, and we will assess the efficacy of this education protocol for patients
      with type 1 diabetes using CGM.
In 50 patients with type 1 diabetes with over 7% of glycated hemoglobin, whose blood glucose
      level is not well controlled, and who are undergoing multiple daily insulin injection therapy
      or insulin pump therapy, continuous glucose monitoring (CGM) is applied to obtain basal
      continuous glucose levels for 1 week (window period of 2 week).

      These 50 patients are 1:1 randomly assigned to 2 groups including control group and
      intervention group. Control group (n=25) applied CGM without structured education and after 3
      months of applying CGM, continuous glucose data for 2 consecutive weeks and HbA1c level, and
      other glycometabolic parameters are collected. As a sequential extension clinical trial,
      those 25 patients in control group are provided structured education, followed by applying
      CGM for 3 months. Continuous glucose levels for 2 consecutive weeks and HbA1c level, and
      other glycometabolic parameters are collected.

      In Intervention group (n=25), structured education program is provided for each patient from
      the time of enrollment, followed by applying CGM for 3 months. Continuous glucose levels for
      2 consecutive weeks and HbA1c level and other blood tests are performed after the 3 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: CGM apply followed by structured education of CGM
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of time in target range 70-180 mg/dL
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
measure: Percentage of time in level 2 hypoglycemia (<54mg/dL)
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Percentage of time in level 2 hypoglycemia (<54mg/dL) by continuous glucose monitoring system
measure: Percentage of time in level 1 hypoglycemia (<70-54mg/dL)
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Percentage of time in level 1 hypoglycemia (<70-54mg/dL) by continuous glucose monitoring system
measure: Percentage of time in level 1 hyperglycemia (>180mg/dL)
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Percentage of time in level 1 hyperglycemia (>180mg/dL) by continuous glucose monitoring system
measure: Percentage of time in level 2 hyperglycemia (>250mg/dL)
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Percentage of time in level 2 hyperglycemia (>250mg/dL) by continuous glucose monitoring system
measure: Glycemic variability, reported as coefficient of variance (CV)
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Glycemic variability, reported as coefficient of variance (CV) by continuous glucose monitoring system
measure: Glycemic variability, reported as standard deviation (SD)
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Glycemic variability, reported as standard deviation (SD) by continuous glucose monitoring system
measure: Mean glucose by continuous glucose monitoring system
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Mean glucose by continuous glucose monitoring system
measure: HbA1C
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: HbA1C
measure: glycated albumin
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: glycated albumin
measure: Personalized education time for each patient
time frame: baseline (intervention group) and 3months (for extension study in control group)
description: Personalized education time for each patient
measure: Frequency of hypoglycemia
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Frequency of hypoglycemia
measure: Adverse event
time frame: 3months (control and intervention groups) and 6months (for extension study in control group)
description: Adverse event occurred
measure: Percentage of time in target range 70-180 mg/dL
time frame: 6months (for extension study in control group)
description: Percentage of time in target range 70-180 mg/dL by continuous glucose monitoring system
arm group label: Control
arm group type: Placebo Comparator
description: Without structured education when applying CGM for 3months, and as a sequential extension clinical trial, after 3 months, structured education is provided, followed by CGM apply
arm group label: Intervention
arm group type: Active Comparator
description: provide structured education when applying CGM for 3 months
intervention type: Behavioral
intervention name: Structured Education for new glucose management devices
description: Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jae Hyeon Kim, MD PhD
phone: 82-2-3410-3439
email: jaehyeonmd.kim@samsung.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Jae Hyeon Kim
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No