xml: <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/NCT06005987</url>
    </required_header>
    <id_info>
      <org_study_id>1992519</org_study_id>
      <nct_id>NCT06005987</nct_id>
    </id_info>
    <brief_title>Mobile App Logging for Diabetes in Pregnancy</brief_title>
    <official_title>Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Carolyn Zahler-Miller</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Augusta University</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>
        To determine the effect of using a mobile app versus paper logs on compliance and percentage&#xD;
        in range blood sugars in monitoring blood sugar in pregnant women with diabetes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and&#xD;
        record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is&#xD;
        often the first time they've had to keep such strict logs. Patients are provided with paper&#xD;
        logs to record their blood sugars, however these can be lost or damaged and often they are&#xD;
        not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study&#xD;
        will be comparing compliance with recording blood sugar values as prescribed with paper logs&#xD;
        versus a mobile app. Subjects will be recruited from the Augusta University downtown location&#xD;
        obstetric clinics.&#xD;
  &#xD;
        Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy&#xD;
        of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational&#xD;
        diabetes diagnosed by 1h glucose tolerance test (GTT) &gt; 200mg/dL or 3h GTT with 2 or more&#xD;
        abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be&#xD;
        remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application&#xD;
        to track blood sugar readings, and type 1 diabetes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Patients will be randomized to two arms. First is traditional logging of blood glucoses with standard paper form in the clinic. The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Cannot mask participant who needs to use the mobile application, or their care provider, or the investigator who will need to teach the patient how to use the application.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Compliance</measure>
      <time_frame>4 weeks</time_frame>
      <description>percentage of actual blood glucose values logged compared to expected.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of in-range blood glucose levels</measure>
      <time_frame>4 weeks</time_frame>
      <description>Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Mobile App arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Paper Log Arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>OneTouch Reveal application</intervention_name>
      <description>Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging</description>
      <arm_group_label>Mobile App arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years and older&#xD;
  &#xD;
            -  Verified intrauterine pregnancy&#xD;
  &#xD;
            -  At least 12 weeks gestation&#xD;
  &#xD;
            -  Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with less than 4 weeks anticipated to be remaining in pregnancy&#xD;
  &#xD;
            -  Pre-existing use of a continuous glucose monitor or other mobile application for&#xD;
               glucose tracking&#xD;
  &#xD;
            -  Type 1 diabetes mellitus&#xD;
  &#xD;
            -  Non-English speaking patients&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Patients must be pregnant.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rebecca Keipper, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Augusta University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rebecca Keipper, MD</last_name>
      <phone>7067212541</phone>
      <email>rkeipper@augusta.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carolyn M Zahler-Miller, MD</last_name>
      <phone>7067212543</phone>
      <email>czahlermiller@augusta.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Augusta University</investigator_affiliation>
      <investigator_full_name>Carolyn Zahler-Miller</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>technology in medicine</keyword>
    <keyword>mobile applications</keyword>
    <keyword>blood glucose monitoring</keyword>
    <keyword>diabetes in pregnancy</keyword>
    <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>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>After study completion and for 2 years afterwards</ipd_time_frame>
      <ipd_access_criteria>contact study PI</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005987
  org study id: 1992519
  nct id: NCT06005987
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To determine the effect of using a mobile app versus paper logs on compliance and percentage
        in range blood sugars in monitoring blood sugar in pregnant women with diabetes.
  Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and
        record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is
        often the first time they've had to keep such strict logs. Patients are provided with paper
        logs to record their blood sugars, however these can be lost or damaged and often they are
        not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study
        will be comparing compliance with recording blood sugar values as prescribed with paper logs
        versus a mobile app. Subjects will be recruited from the Augusta University downtown location
        obstetric clinics.
  
        Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy
        of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational
        diabetes diagnosed by 1h glucose tolerance test (GTT) > 200mg/dL or 3h GTT with 2 or more
        abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be
        remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application
        to track blood sugar readings, and type 1 diabetes.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomized to two arms. First is traditional logging of blood glucoses with standard paper form in the clinic. The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Cannot mask participant who needs to use the mobile application, or their care provider, or the investigator who will need to teach the patient how to use the application.
  measure: Compliance
  time frame: 4 weeks
  description: percentage of actual blood glucose values logged compared to expected.
  measure: Percentage of in-range blood glucose levels
  time frame: 4 weeks
  description: Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.
  arm group label: Mobile App arm
  arm group type: Experimental
  description: Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app
  arm group label: Paper Log Arm
  arm group type: No Intervention
  description: Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.
  intervention type: Behavioral
  intervention name: OneTouch Reveal application
  description: Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging
  arm group label: Mobile App arm
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Patients must be pregnant.
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rebecca Keipper, MD
  role: Principal Investigator
  affiliation: Augusta University
  last name: Rebecca Keipper, MD
  phone: 7067212541
  email: rkeipper@augusta.edu
  last name: Carolyn M Zahler-Miller, MD
  phone: 7067212543
  email: czahlermiller@augusta.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: Augusta University
  investigator full name: Carolyn Zahler-Miller
  investigator title: Associate Professor
  mesh term: Diabetes, Gestational
  mesh term: Pregnancy in Diabetics
  mesh term: Diabetes Mellitus
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: After study completion and for 2 years afterwards
  ipd access criteria: contact study PI