<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/NCT03033407</url>
  </required_header>
  <id_info>
    <org_study_id>KBSMC 2014-09-021</org_study_id>
    <nct_id>NCT03033407</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy of Diabetes Management Based on Ubiquitous Healthcare System</brief_title>
  <official_title>A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of the S-Diabetes Care Program Based on Ubiquitous Healthcare System in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kangbuk Samsung Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kangbuk Samsung Hospital</source>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate whether adding tailored mobile coaching system to&#xD;
      present community primary care for diabetes management would result in better glycemic&#xD;
      control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared&#xD;
      with maintaining usual diabetes management only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The incidence and prevalence of type 2 diabetes is increasing rapidly worldwide. Considering&#xD;
      the fact that complications of diabetes result in greater expenditure and reduced&#xD;
      productivity is a socioeconomic concern, adequate glycemic control is important not only as&#xD;
      individual health problem but also as challenge to healthcare systems worldwide. To support&#xD;
      patients' behavior change efforts, including healthy lifestyle choices, disease&#xD;
      self-management, and prevention of diabetes complication, multifaceted professional&#xD;
      interventions are needed. Ubiquitous healthcare based on information and communication&#xD;
      technology is one of these approaches.&#xD;
&#xD;
      The aim of this study is to investigate whether adding tailored mobile coaching system to&#xD;
      present community primary care for diabetes management would result in better glycemic&#xD;
      control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared&#xD;
      with maintaining usual diabetes management only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>It was open label study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>glycated hemoglobin levels</measure>
    <time_frame>at 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in glycated hemoglobin levels within each group</measure>
    <time_frame>between baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in body mass index within each group</measure>
    <time_frame>between baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in low-density lipoprotein cholesterol within each group</measure>
    <time_frame>between baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in high-density lipoprotein cholesterol within each group</measure>
    <time_frame>between baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in triglyceride within each group</measure>
    <time_frame>between baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood pressure within each group</measure>
    <time_frame>between baseline and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention-Maintenance group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. This study was divided into two phases. In six-month phase 1 study, the participants in I-M group received tailored mobile coaching. And during the second half six-month phase 2 study, they could receive only regular information messages without individualized coaching.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control-Intervention group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. In six-month phase 1 study, the participants in Control-Intervention group maintained usual care for diabetes. During the second half six-month phase 2 study, they received tailored mobile coaching.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tailored mobile coaching messages</intervention_name>
    <description>Intervention was adding tailored mobile coaching to current usual diabetes care. The participants received regular mobile messages via Switch app according to entered data, such as self-monitoring of blood glucose, blood pressure, exercise, dietary record, medication record, and body weight. Contents of messages were alert for the unused, weather, behavioral recommendation, education about diabetes, and individualized advices.</description>
    <arm_group_label>Control-Intervention group</arm_group_label>
    <arm_group_label>Intervention-Maintenance group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Korean policyholders with type 2 diabetes;&#xD;
&#xD;
          -  Aged ≥ 19 years;&#xD;
&#xD;
          -  Smartphone users;&#xD;
&#xD;
          -  Glycated hemoglobin (HbA1c) ≥ 6.5% within 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently had serious concomitant disease other than diabetes;&#xD;
&#xD;
          -  Had admission histories due to malignancy, myocardial infarction, cerebral infarction,&#xD;
             or organ transplantation;&#xD;
&#xD;
          -  Pregnant or had plan for pregnancy within 6 months;&#xD;
&#xD;
          -  Planned for attending other clinical;&#xD;
&#xD;
          -  Illiteracy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kangbuk Samsung Hospital</investigator_affiliation>
    <investigator_full_name>Cheol-Young Park</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT03033407
org study id: KBSMC 2014-09-021
nct id: NCT03033407
lead sponsor: 
The aim of this study is to investigate whether adding tailored mobile coaching system to
      present community primary care for diabetes management would result in better glycemic
      control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared
      with maintaining usual diabetes management only.
The incidence and prevalence of type 2 diabetes is increasing rapidly worldwide. Considering
      the fact that complications of diabetes result in greater expenditure and reduced
      productivity is a socioeconomic concern, adequate glycemic control is important not only as
      individual health problem but also as challenge to healthcare systems worldwide. To support
      patients' behavior change efforts, including healthy lifestyle choices, disease
      self-management, and prevention of diabetes complication, multifaceted professional
      interventions are needed. Ubiquitous healthcare based on information and communication
      technology is one of these approaches.

      The aim of this study is to investigate whether adding tailored mobile coaching system to
      present community primary care for diabetes management would result in better glycemic
      control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared
      with maintaining usual diabetes management only.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: It was open label study.
measure: glycated hemoglobin levels
time frame: at 6 months
measure: change in glycated hemoglobin levels within each group
time frame: between baseline and 6 months
measure: change in body mass index within each group
time frame: between baseline and 6 months
measure: change in low-density lipoprotein cholesterol within each group
time frame: between baseline and 6 months
measure: change in high-density lipoprotein cholesterol within each group
time frame: between baseline and 6 months
measure: change in triglyceride within each group
time frame: between baseline and 6 months
measure: change in blood pressure within each group
time frame: between baseline and 6 months
arm group label: Intervention-Maintenance group
arm group type: Experimental
description: Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. This study was divided into two phases. In six-month phase 1 study, the participants in I-M group received tailored mobile coaching. And during the second half six-month phase 2 study, they could receive only regular information messages without individualized coaching.
arm group label: Control-Intervention group
arm group type: Active Comparator
description: Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. In six-month phase 1 study, the participants in Control-Intervention group maintained usual care for diabetes. During the second half six-month phase 2 study, they received tailored mobile coaching.
intervention type: Other
intervention name: Tailored mobile coaching messages
description: Intervention was adding tailored mobile coaching to current usual diabetes care. The participants received regular mobile messages via Switch app according to entered data, such as self-monitoring of blood glucose, blood pressure, exercise, dietary record, medication record, and body weight. Contents of messages were alert for the unused, weather, behavioral recommendation, education about diabetes, and individualized advices.
arm group label: Control-Intervention group
arm group label: Intervention-Maintenance group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kangbuk Samsung Hospital
investigator full name: Cheol-Young Park
investigator title: Prof.
mesh term: Diabetes Mellitus
sharing ipd: No