<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/NCT03838380</url>
  </required_header>
  <id_info>
    <org_study_id>KBSMC2016-11-049</org_study_id>
    <nct_id>NCT03838380</nct_id>
  </id_info>
  <brief_title>Smartphone Application for the Management of Gestational Diabetes Mellitus</brief_title>
  <official_title>Peripartum Management of Gestational Diabetes Using a Digital Healthcare Service: a Pilot, Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kangbuk Samsung Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kangbuk Samsung 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>
      The prevalence of gestational diabetes mellitus (GDM) has been progressively increasing. It&#xD;
      is important to recognize and treat GDM to minimize the risk of maternal and neonatal&#xD;
      complications. Multifaceted professional interventions are effective in the management of GDM&#xD;
      and mobile healthcare can be an effective approach. The purpose of the current study was to&#xD;
      develop and evaluate a model for prevention and management of GDM using mobile healthcare.&#xD;
      Subjects with no previous history of diabetes, who were diagnosed with GDM during 24-28 weeks&#xD;
      of gestation, were randomly divided into a conventional management group and a mobile&#xD;
      management group. The conventional mangement group received conventional GDM management and&#xD;
      could freely use the mobile healthcare application. The mobile management group received&#xD;
      mobile healthcare services including tailored mobile coaching. The effectiveness of the&#xD;
      management using the application were evaluated through the result values of the laboratory&#xD;
      tests, anthropometric measurement performed during the study period and perinatal outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hemoglobin A1c levels</measure>
    <time_frame>up to 4 to 12weeks after delivery</time_frame>
    <description>serum glycated hemoglobin levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body weight</measure>
    <time_frame>up to 4 to 12weeks after delivery</time_frame>
    <description>the changes in body weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body mass index</measure>
    <time_frame>up to 4 to 12weeks after delivery</time_frame>
    <description>the changes in body mass index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percent body fat</measure>
    <time_frame>up to 4 to 12weeks after delivery</time_frame>
    <description>the changes in percent body fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA IR(homeostatic model assessment insulin resistance)</measure>
    <time_frame>up to 4 to 12weeks after delivery</time_frame>
    <description>the changes in insulin resistance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA-ß (homeostatic model assessment ß-cell dysfunction )</measure>
    <time_frame>up to 4 to 12weeks after delivery</time_frame>
    <description>the changes in ß-cell dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonate large for gestational age</measure>
    <time_frame>at the day of delivery</time_frame>
    <description>Birth weight of neonates of GDM patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>at the day of delivery</time_frame>
    <description>Rate of cesarean section</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>conventional management group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The conventional management group received standard GDM management and could freely use the smartphone healthcare application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mobile management group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Smartphone application</intervention_name>
    <description>Mobile management group participants were given monitoring system devices including a glucometer with Bluetooth connectivity and an accelerometer to detect physical activity level. The mobile phone application specifically designed for this study was installed at enrollment for the mobile management group to collect clinical data and messages from the patients. The application consisted of four sections: clinical data, nutrition and diet, medication, and messaging system and information. Patients allocated to the mobile management group recorded their blood glucose level and diet via the smartphone application, and health care providers regularly scanned clinical data and messages from patients and sent return messages with tailored medical and nutritional guidance.</description>
    <arm_group_label>mobile management group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnant women diagnosed as GDM at 24 to 28 weeks of gestation were&#xD;
             included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients after 30th week of gestation and patients with pregestational diabetes were&#xD;
             excluded from participating in the study. Patients who were unable to understand&#xD;
             Korean, were unfamiliar with mobile phones, who did not have access to a mobile phone,&#xD;
             or who were already receiving services from another mobile healthcare agency were also&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kangbuk Samsung hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</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>Professor, Division of Endocrionology and metabolism, Department of Internal medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <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/NCT03838380
org study id: KBSMC2016-11-049
nct id: NCT03838380
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence of gestational diabetes mellitus (GDM) has been progressively increasing. It
      is important to recognize and treat GDM to minimize the risk of maternal and neonatal
      complications. Multifaceted professional interventions are effective in the management of GDM
      and mobile healthcare can be an effective approach. The purpose of the current study was to
      develop and evaluate a model for prevention and management of GDM using mobile healthcare.
      Subjects with no previous history of diabetes, who were diagnosed with GDM during 24-28 weeks
      of gestation, were randomly divided into a conventional management group and a mobile
      management group. The conventional mangement group received conventional GDM management and
      could freely use the mobile healthcare application. The mobile management group received
      mobile healthcare services including tailored mobile coaching. The effectiveness of the
      management using the application were evaluated through the result values of the laboratory
      tests, anthropometric measurement performed during the study period and perinatal outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: hemoglobin A1c levels
time frame: up to 4 to 12weeks after delivery
description: serum glycated hemoglobin levels
measure: body weight
time frame: up to 4 to 12weeks after delivery
description: the changes in body weight
measure: body mass index
time frame: up to 4 to 12weeks after delivery
description: the changes in body mass index
measure: percent body fat
time frame: up to 4 to 12weeks after delivery
description: the changes in percent body fat
measure: HOMA IR(homeostatic model assessment insulin resistance)
time frame: up to 4 to 12weeks after delivery
description: the changes in insulin resistance
measure: HOMA-ß (homeostatic model assessment ß-cell dysfunction )
time frame: up to 4 to 12weeks after delivery
description: the changes in ß-cell dysfunction
measure: Neonate large for gestational age
time frame: at the day of delivery
description: Birth weight of neonates of GDM patients
measure: Mode of delivery
time frame: at the day of delivery
description: Rate of cesarean section
arm group label: conventional management group
arm group type: No Intervention
description: The conventional management group received standard GDM management and could freely use the smartphone healthcare application.
arm group label: mobile management group
arm group type: Experimental
description: The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.
intervention type: Other
intervention name: Smartphone application
description: Mobile management group participants were given monitoring system devices including a glucometer with Bluetooth connectivity and an accelerometer to detect physical activity level. The mobile phone application specifically designed for this study was installed at enrollment for the mobile management group to collect clinical data and messages from the patients. The application consisted of four sections: clinical data, nutrition and diet, medication, and messaging system and information. Patients allocated to the mobile management group recorded their blood glucose level and diet via the smartphone application, and health care providers regularly scanned clinical data and messages from patients and sent return messages with tailored medical and nutritional guidance.
arm group label: mobile management group
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kangbuk Samsung Hospital
investigator full name: Cheol-Young Park
investigator title: Professor, Division of Endocrionology and metabolism, Department of Internal medicine
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: No