<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/NCT04424238</url>
  </required_header>
  <id_info>
    <org_study_id>JS-1012</org_study_id>
    <nct_id>NCT04424238</nct_id>
  </id_info>
  <brief_title>the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes</brief_title>
  <official_title>Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A multicenter, randomized controlled trial was conducted to investigate whether health&#xD;
      education and life style management through WeChat group chat was more effective in&#xD;
      controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most gestational diabetes mellitus (GDM) can be well controlled by health education and life&#xD;
      style management, expecting a better pregnancy outcome. But standard clinic prenatal care&#xD;
      which consist of clinic visit every two weeks may not give full play to the effects of GDM&#xD;
      management. Telemedicine shows its potential to fill this gap. A multicenter, randomized&#xD;
      controlled trial was designed to investigate whether health education and life style&#xD;
      management through WeChat group chat was more effective in controlling blood glucose (BG)&#xD;
      than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral&#xD;
      glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group&#xD;
      chat-based blood glucose management group or routine clinic prenatal care. In PUMCH,&#xD;
      investigators also equip CGM for m-health group allowing a more detailed BG information. The&#xD;
      primary outcome was change of glycemic qualification rate during follow up period in both&#xD;
      groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to&#xD;
      compare the glucose control status between rice-richen meal and wheaten-richen meal, and all&#xD;
      other macronutrients and micronutrients are all calculated and same between two groups, which&#xD;
      may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 15, 2016</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>glycemic qualification rate</measure>
    <time_frame>From enrollment to 42 days postpartum</time_frame>
    <description>Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)&lt;95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)&lt;120 mg/dL (6.7 mmol/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pregnancy outcome</measure>
    <time_frame>delivery</time_frame>
    <description>delivery mode, premature rupture of the membranes, preterm birth, birthweight and postpartum hemorrhage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>GDM</condition>
  <condition>Blood Glucose</condition>
  <condition>Compliance, Patient</condition>
  <condition>Diet Habit</condition>
  <arm_group>
    <arm_group_label>Standard Clinic Prenatal Care (Control Group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>m-health group (Intervention Group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants were managed continuously through WeChat group chat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>m-health management</intervention_name>
    <description>Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care.</description>
    <arm_group_label>m-health group (Intervention Group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 18 and 45 years.&#xD;
&#xD;
          -  With singleton pregnancy&#xD;
&#xD;
          -  Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is&#xD;
             not required assessed by multi-disciplinary consultation.&#xD;
&#xD;
          -  Be able to use smart phone for chatting, read and write basic Chinese.&#xD;
&#xD;
          -  Volunteer for research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancies with diagnosed chronic disease&#xD;
&#xD;
          -  Pregnancies with other pregnancy complications except GDM&#xD;
&#xD;
          -  Pregnancies had recent trauma and treatment of glucocorticoids&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liangkun Ma</last_name>
    <role>Study Chair</role>
    <affiliation>Chinese Academy of Medical Science &amp; Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GDM</keyword>
  <keyword>CGM</keyword>
  <keyword>m-health</keyword>
  <keyword>diet modification</keyword>
  <keyword>blood glucose</keyword>
  <keyword>compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</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/NCT04424238
org study id: JS-1012
nct id: NCT04424238
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A multicenter, randomized controlled trial was conducted to investigate whether health
      education and life style management through WeChat group chat was more effective in
      controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.
Most gestational diabetes mellitus (GDM) can be well controlled by health education and life
      style management, expecting a better pregnancy outcome. But standard clinic prenatal care
      which consist of clinic visit every two weeks may not give full play to the effects of GDM
      management. Telemedicine shows its potential to fill this gap. A multicenter, randomized
      controlled trial was designed to investigate whether health education and life style
      management through WeChat group chat was more effective in controlling blood glucose (BG)
      than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral
      glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group
      chat-based blood glucose management group or routine clinic prenatal care. In PUMCH,
      investigators also equip CGM for m-health group allowing a more detailed BG information. The
      primary outcome was change of glycemic qualification rate during follow up period in both
      groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to
      compare the glucose control status between rice-richen meal and wheaten-richen meal, and all
      other macronutrients and micronutrients are all calculated and same between two groups, which
      may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: glycemic qualification rate
time frame: From enrollment to 42 days postpartum
description: Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)<95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)<120 mg/dL (6.7 mmol/L)
measure: pregnancy outcome
time frame: delivery
description: delivery mode, premature rupture of the membranes, preterm birth, birthweight and postpartum hemorrhage
arm group label: Standard Clinic Prenatal Care (Control Group)
arm group type: No Intervention
description: pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered.
arm group label: m-health group (Intervention Group)
arm group type: Experimental
description: participants were managed continuously through WeChat group chat.
intervention type: Behavioral
intervention name: m-health management
description: Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care.
arm group label: m-health group (Intervention Group)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Liangkun Ma
role: Study Chair
affiliation: Chinese Academy of Medical Science & Peking Union Medical College Hospital
responsible party type: Sponsor
mesh term: Diabetes, Gestational
sharing ipd: No