<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/NCT03026218</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00071275</org_study_id>
    <nct_id>NCT03026218</nct_id>
  </id_info>
  <brief_title>Group and Mobile Care for Gestational Diabetes</brief_title>
  <official_title>Group and Mobile Care for Gestational Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A critical variation in the provision of prenatal care to women with GDM is the need to keep&#xD;
      patients engaged with their care between visits by tracking glucose levels using finger&#xD;
      sticks and making dietary and other lifestyle modifications to keep these levels at or close&#xD;
      to normal. Multiple studies have demonstrated that the use of mobile devices can improve&#xD;
      medical outcomes. In order to keep patients engaged between appointments and improve&#xD;
      self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition&#xD;
      therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with&#xD;
      GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give&#xD;
      the user positive feedback and rewards for using the system. This model of group care with&#xD;
      mobile phone monitoring and reminders for women with GDM has not been previously studied. A&#xD;
      randomized control trial is purposed to determine if this approach improves patient care. The&#xD;
      investigators hypothesize that group prenatal care along with inter-session mobile therapy&#xD;
      will increase dietary compliance and therefore reduce the number of individuals requiring&#xD;
      pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care&#xD;
      (GPC) will provide a community foundation to improve learning and increase the motivation of&#xD;
      patients to learn and change. This motivation will be further strengthened by the use of the&#xD;
      GlucoseMama monitoring system which will provide each patient with glucose tracking and&#xD;
      individualized nutritional support.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2017</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 15, 2018</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>Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in the number of neonates born large for gestational age.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increased number of individuals who are screened in the postpartum period for type 2 diabetes.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction in the number of infants with neonatal hypoglycemia.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Group and Glucose Mama</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects with have GlucoseMama application and group care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group and No Glucose Mama</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional and glucoseMama</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enrolled subjects will have traditional care and glucoseMama</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional and no GlucoseMama</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>enrolled subjects will not have access to group care or GlucoseMama.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GlucoseMama application with blood sugar monitoring and carb monitoring.</intervention_name>
    <description>We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.</description>
    <arm_group_label>Group and Glucose Mama</arm_group_label>
    <arm_group_label>Traditional and glucoseMama</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group prenatal care for GDM.</intervention_name>
    <description>group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.</description>
    <arm_group_label>Group and Glucose Mama</arm_group_label>
    <arm_group_label>Group and No Glucose Mama</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Gestational Diabetes&#xD;
&#xD;
          -  Planning on delivering at home institution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to participate.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>51 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Maryland, Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Sarah Crimmins</investigator_full_name>
    <investigator_title>Assistant Professor</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>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- 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/NCT03026218
org study id: HP-00071275
nct id: NCT03026218
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A critical variation in the provision of prenatal care to women with GDM is the need to keep
      patients engaged with their care between visits by tracking glucose levels using finger
      sticks and making dietary and other lifestyle modifications to keep these levels at or close
      to normal. Multiple studies have demonstrated that the use of mobile devices can improve
      medical outcomes. In order to keep patients engaged between appointments and improve
      self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition
      therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with
      GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give
      the user positive feedback and rewards for using the system. This model of group care with
      mobile phone monitoring and reminders for women with GDM has not been previously studied. A
      randomized control trial is purposed to determine if this approach improves patient care. The
      investigators hypothesize that group prenatal care along with inter-session mobile therapy
      will increase dietary compliance and therefore reduce the number of individuals requiring
      pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care
      (GPC) will provide a community foundation to improve learning and increase the motivation of
      patients to learn and change. This motivation will be further strengthened by the use of the
      GlucoseMama monitoring system which will provide each patient with glucose tracking and
      individualized nutritional support.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes
time frame: 2 years
measure: Reduction in the number of neonates born large for gestational age.
time frame: 2 years
measure: Increased number of individuals who are screened in the postpartum period for type 2 diabetes.
time frame: 2 years
measure: Reduction in the number of infants with neonatal hypoglycemia.
time frame: 2 years
arm group label: Group and Glucose Mama
arm group type: Experimental
description: Enrolled subjects with have GlucoseMama application and group care.
arm group label: Group and No Glucose Mama
arm group type: Placebo Comparator
description: Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application.
arm group label: Traditional and glucoseMama
arm group type: Experimental
description: Enrolled subjects will have traditional care and glucoseMama
arm group label: Traditional and no GlucoseMama
arm group type: No Intervention
description: enrolled subjects will not have access to group care or GlucoseMama.
intervention type: Other
intervention name: GlucoseMama application with blood sugar monitoring and carb monitoring.
description: We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.
arm group label: Group and Glucose Mama
arm group label: Traditional and glucoseMama
intervention type: Other
intervention name: Group prenatal care for GDM.
description: group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.
arm group label: Group and Glucose Mama
arm group label: Group and No Glucose Mama
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 51 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Sarah Crimmins
investigator title: Assistant Professor
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus