<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/NCT03025984</url>
  </required_header>
  <id_info>
    <org_study_id>22596</org_study_id>
    <nct_id>NCT03025984</nct_id>
  </id_info>
  <brief_title>Texting for Diabetes</brief_title>
  <official_title>Adherence to a Diabetes Care Regimen Following Text Message Intervention in Pregnant Women With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes is a common complication of pregnancy that increases risks for both the mother and&#xD;
      baby. Poorly controlled diabetes has been associated with very large babies, congenital heart&#xD;
      defects, stillbirth, birth trauma, and maternal infections among other complications.&#xD;
      Patients with diabetes in pregnancy require more frequent prenatal visits and fetal&#xD;
      evaluation, and must shoulder the burden of mastering management of a complicated care&#xD;
      regimen. With the ever-expanding world of technology, more healthcare practices are using&#xD;
      cell phones, texting, and social media to interact with patients. Use of this technology has&#xD;
      been successful in management of chronic diseases and as reminder systems. The investigators&#xD;
      propose a randomized clinical trial to investigate patient adherence to recommended care&#xD;
      regimen after intervention of a text message reminder and education system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a part of routine care, pregnant women without known diabetes undergo screening and&#xD;
      testing for gestational diabetes either with a two-hour glucose tolerance testing or a&#xD;
      one-hour glucose challenge test followed by a three-hour glucose tolerance test in the event&#xD;
      of failure of the one-hour test.&#xD;
&#xD;
      Women who have been given the diagnosis of gestational diabetes mellitus (GDM) by failing&#xD;
      this diabetes testing and who meet the inclusion and exclusion criteria shall be approached&#xD;
      and offered enrollment in the study. Women with known type 2 diabetes mellitus (T2DM)&#xD;
      (pre-gestational diabetes) and women diagnosed elsewhere with GDM who meet the inclusion and&#xD;
      exclusion criteria will be offered enrollment when they establish prenatal care. Patients who&#xD;
      consent to participate in the study shall be randomized to either the intervention or the&#xD;
      contact control group. For randomization purposes, an equal number of notecards will be made&#xD;
      for the two groups. These will all be placed in sealed envelopes and shuffled. At the time of&#xD;
      patient inclusion, an envelope will be selected by the consenting practitioner. If a patient&#xD;
      declines receiving text messages but consents to have her medical record reviewed for&#xD;
      adherence to her diabetes care regimen and glycemic control, she will be enrolled in the&#xD;
      standard of care control group. A baseline hemoglobin A1c (HbA1c) is obtained.&#xD;
&#xD;
      Patients in all groups shall receive initial diabetes education and started on an&#xD;
      individualized diabetic diet regimen. Patients with GDM who develop a requirement for either&#xD;
      oral medication or insulin will remain in the same group to which they were initially&#xD;
      randomized. An HbA1c level is obtained every one to three months during pregnancy as well as&#xD;
      near the time of delivery.&#xD;
&#xD;
      Patients in the intervention group will receive reminders based on their individual disease&#xD;
      treatment. A text message shall be sent one day (12 to 36 hours) before appointments to&#xD;
      remind about the appointment and with instructions to bring glucose and food records to the&#xD;
      appointment. If medication changes are made at the appointment, the patient will receive a&#xD;
      text message reminder the day after her appointment to reinforce the regimen. Postpartum&#xD;
      patients who had GDM will receive a text message reminder to complete their glucose tolerance&#xD;
      test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10&#xD;
      weeks postpartum if the testing is not completed. Women with T2DM will be reminded to bring&#xD;
      glucose and food records to their postpartum visits. Participants will be contacted through&#xD;
      Google Voice which is a Google system requiring a secure login and password.&#xD;
&#xD;
      Patients in the contact control group will be enrolled in the text4baby program with&#xD;
      assistance from a healthcare provider. As the study will conclude upon the patient's&#xD;
      postpartum visit, she will be offered the option of discontinuing messages, which otherwise&#xD;
      would continue through the infant's first year of life.&#xD;
&#xD;
      Hospitalizations Patient hospitalization for diabetic control shall be recorded for data&#xD;
      collection. Patients in the intervention group will not be contacted during their&#xD;
      hospitalization. If medicine adjustments are made during their hospitalization, a reminder&#xD;
      text message with the new regimen shall be sent the day after discharge. Contact will then&#xD;
      resume by the above stated schedule. If a patient is hospitalized temporarily for a reason&#xD;
      other than diabetes, contact will resume upon discharge. If the patient is hospitalized for&#xD;
      the remainder of the pregnancy, the patient will be removed from the study. Triage visits&#xD;
      will not be followed.&#xD;
&#xD;
      Delivery Delivery details will be abstracted from patient charts and shall include&#xD;
      gestational age at delivery, fetal weight, vaginal versus cesarean delivery, incidence of&#xD;
      shoulder dystocia, APGAR scores, and umbilical cord blood gases. The newborn chart shall be&#xD;
      reviewed for the number of days spent in the neonatal intensive care unit, incidence of&#xD;
      hypoglycemia and whether IV dextrose was required, and need for ventilator support or&#xD;
      surfactant administration.&#xD;
&#xD;
      Maternal Complications Incidence of postpartum wound infections or dehiscence shall be&#xD;
      collected.&#xD;
&#xD;
      Postpartum The postpartum glucose tolerance tests of women who had GDM will be reviewed to&#xD;
      determine her glucose tolerance status.&#xD;
&#xD;
      Questionnaires/Surveys The participating patients will be asked to complete a survey upon&#xD;
      entry into the study to identify barriers to their healthcare and their baseline knowledge of&#xD;
      diabetes. A survey at the completion of their study (the postpartum visit or later) will be&#xD;
      requested to evaluate patient perspectives on the study, their pregnancy and any perceived&#xD;
      benefit from participation. The postpartum survey will be either completed at a postpartum&#xD;
      visit, mailed to subjects, completed on line or subjects will be contacted by phone to&#xD;
      complete the survey. If subjects do not return for a postpartum visit or do not complete the&#xD;
      survey at that visit, three attempts will be made to contact subject for completion of the&#xD;
      departure survey.&#xD;
&#xD;
      For participants who did not sign a version of the consent form that allowed for completion&#xD;
      of the departure survey over the phone or online:&#xD;
&#xD;
      If their participation is ongoing, they will be approached at one of their visits and asked&#xD;
      to review and sign an updated version of the consent form.&#xD;
&#xD;
      For subjects who have completed the pregnancy portion of their participation in the study but&#xD;
      who did not complete a departure survey:&#xD;
&#xD;
      Subjects will be contacted over the phone to obtain permission to allow completion of this&#xD;
      survey over the phone, by mail or online. A phone script will be used to contact patients. If&#xD;
      subjects cannot be reached by phone, a letter will be sent to their home address. A maximum&#xD;
      of three phone attempts will be made to contact subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>compliant diabetes care</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Compliant with appointments, maintaining diabetes records, and medications, including glycemic control and pregnancy complications.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">185</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Texting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the &quot;Texting&quot; group will receive reminders based on their individual disease treatment. A text message shall be sent one day (12 to 36 hours) before appointments to remind about the appointment and with instructions to bring glucose and food records to the appointment. If medication changes are made at the appointment, the patient will receive a text message reminder the day after her appointment to reinforce the regimen. Postpartum patients who had GDM will receive a text message reminder to complete their glucose tolerance test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10 weeks postpartum if the testing is not completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No texting</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the contact control group will be enrolled in the text4baby program with assistance from a healthcare provider. As the study will conclude upon the patient's postpartum visit, she will be offered the option of discontinuing messages, which otherwise would continue through the infant's first year of life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Texting</intervention_name>
    <description>patient adherence to her recommended care regimen after intervention of a text message reminder and education system</description>
    <arm_group_label>Texting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient is a pregnant female 18 years of age or older&#xD;
&#xD;
          2. The patient has been diagnosed with gestational diabetes or is a patient with known&#xD;
             diabetes and a confirmed viable pregnancy&#xD;
&#xD;
          3. The pregnancy has a singleton pregnancy&#xD;
&#xD;
          4. The patient has access to a cellular phone with a text messaging plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient does not have a cellular phone&#xD;
&#xD;
          2. The patient becomes hospitalized for a pregnancy complication for the remainder of&#xD;
             pregnancy&#xD;
&#xD;
          3. The fetus has a chromosomal or non-chromosomal malformation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dorothea Mostello, MD</last_name>
    <role>Study Chair</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Mary's Health Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 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>November 11, 2022</last_update_submitted>
  <last_update_submitted_qc>November 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Dorothea Mostello, MD</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03025984
org study id: 22596
nct id: NCT03025984
lead sponsor: 
has dmc: No
Diabetes is a common complication of pregnancy that increases risks for both the mother and
      baby. Poorly controlled diabetes has been associated with very large babies, congenital heart
      defects, stillbirth, birth trauma, and maternal infections among other complications.
      Patients with diabetes in pregnancy require more frequent prenatal visits and fetal
      evaluation, and must shoulder the burden of mastering management of a complicated care
      regimen. With the ever-expanding world of technology, more healthcare practices are using
      cell phones, texting, and social media to interact with patients. Use of this technology has
      been successful in management of chronic diseases and as reminder systems. The investigators
      propose a randomized clinical trial to investigate patient adherence to recommended care
      regimen after intervention of a text message reminder and education system.
As a part of routine care, pregnant women without known diabetes undergo screening and
      testing for gestational diabetes either with a two-hour glucose tolerance testing or a
      one-hour glucose challenge test followed by a three-hour glucose tolerance test in the event
      of failure of the one-hour test.

      Women who have been given the diagnosis of gestational diabetes mellitus (GDM) by failing
      this diabetes testing and who meet the inclusion and exclusion criteria shall be approached
      and offered enrollment in the study. Women with known type 2 diabetes mellitus (T2DM)
      (pre-gestational diabetes) and women diagnosed elsewhere with GDM who meet the inclusion and
      exclusion criteria will be offered enrollment when they establish prenatal care. Patients who
      consent to participate in the study shall be randomized to either the intervention or the
      contact control group. For randomization purposes, an equal number of notecards will be made
      for the two groups. These will all be placed in sealed envelopes and shuffled. At the time of
      patient inclusion, an envelope will be selected by the consenting practitioner. If a patient
      declines receiving text messages but consents to have her medical record reviewed for
      adherence to her diabetes care regimen and glycemic control, she will be enrolled in the
      standard of care control group. A baseline hemoglobin A1c (HbA1c) is obtained.

      Patients in all groups shall receive initial diabetes education and started on an
      individualized diabetic diet regimen. Patients with GDM who develop a requirement for either
      oral medication or insulin will remain in the same group to which they were initially
      randomized. An HbA1c level is obtained every one to three months during pregnancy as well as
      near the time of delivery.

      Patients in the intervention group will receive reminders based on their individual disease
      treatment. A text message shall be sent one day (12 to 36 hours) before appointments to
      remind about the appointment and with instructions to bring glucose and food records to the
      appointment. If medication changes are made at the appointment, the patient will receive a
      text message reminder the day after her appointment to reinforce the regimen. Postpartum
      patients who had GDM will receive a text message reminder to complete their glucose tolerance
      test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10
      weeks postpartum if the testing is not completed. Women with T2DM will be reminded to bring
      glucose and food records to their postpartum visits. Participants will be contacted through
      Google Voice which is a Google system requiring a secure login and password.

      Patients in the contact control group will be enrolled in the text4baby program with
      assistance from a healthcare provider. As the study will conclude upon the patient's
      postpartum visit, she will be offered the option of discontinuing messages, which otherwise
      would continue through the infant's first year of life.

      Hospitalizations Patient hospitalization for diabetic control shall be recorded for data
      collection. Patients in the intervention group will not be contacted during their
      hospitalization. If medicine adjustments are made during their hospitalization, a reminder
      text message with the new regimen shall be sent the day after discharge. Contact will then
      resume by the above stated schedule. If a patient is hospitalized temporarily for a reason
      other than diabetes, contact will resume upon discharge. If the patient is hospitalized for
      the remainder of the pregnancy, the patient will be removed from the study. Triage visits
      will not be followed.

      Delivery Delivery details will be abstracted from patient charts and shall include
      gestational age at delivery, fetal weight, vaginal versus cesarean delivery, incidence of
      shoulder dystocia, APGAR scores, and umbilical cord blood gases. The newborn chart shall be
      reviewed for the number of days spent in the neonatal intensive care unit, incidence of
      hypoglycemia and whether IV dextrose was required, and need for ventilator support or
      surfactant administration.

      Maternal Complications Incidence of postpartum wound infections or dehiscence shall be
      collected.

      Postpartum The postpartum glucose tolerance tests of women who had GDM will be reviewed to
      determine her glucose tolerance status.

      Questionnaires/Surveys The participating patients will be asked to complete a survey upon
      entry into the study to identify barriers to their healthcare and their baseline knowledge of
      diabetes. A survey at the completion of their study (the postpartum visit or later) will be
      requested to evaluate patient perspectives on the study, their pregnancy and any perceived
      benefit from participation. The postpartum survey will be either completed at a postpartum
      visit, mailed to subjects, completed on line or subjects will be contacted by phone to
      complete the survey. If subjects do not return for a postpartum visit or do not complete the
      survey at that visit, three attempts will be made to contact subject for completion of the
      departure survey.

      For participants who did not sign a version of the consent form that allowed for completion
      of the departure survey over the phone or online:

      If their participation is ongoing, they will be approached at one of their visits and asked
      to review and sign an updated version of the consent form.

      For subjects who have completed the pregnancy portion of their participation in the study but
      who did not complete a departure survey:

      Subjects will be contacted over the phone to obtain permission to allow completion of this
      survey over the phone, by mail or online. A phone script will be used to contact patients. If
      subjects cannot be reached by phone, a letter will be sent to their home address. A maximum
      of three phone attempts will be made to contact subject.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: compliant diabetes care
time frame: up to 12 months
description: Compliant with appointments, maintaining diabetes records, and medications, including glycemic control and pregnancy complications.
arm group label: Texting
arm group type: Active Comparator
description: Patients in the "Texting" group will receive reminders based on their individual disease treatment. A text message shall be sent one day (12 to 36 hours) before appointments to remind about the appointment and with instructions to bring glucose and food records to the appointment. If medication changes are made at the appointment, the patient will receive a text message reminder the day after her appointment to reinforce the regimen. Postpartum patients who had GDM will receive a text message reminder to complete their glucose tolerance test. A reminder will be sent at 2 weeks postpartum followed by a reminder at 6 weeks and 10 weeks postpartum if the testing is not completed.
arm group label: No texting
arm group type: No Intervention
description: Patients in the contact control group will be enrolled in the text4baby program with assistance from a healthcare provider. As the study will conclude upon the patient's postpartum visit, she will be offered the option of discontinuing messages, which otherwise would continue through the infant's first year of life.
intervention type: Behavioral
intervention name: Texting
description: patient adherence to her recommended care regimen after intervention of a text message reminder and education system
arm group label: Texting
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Dorothea Mostello, MD
role: Study Chair
affiliation: St. Louis University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Dorothea Mostello, MD
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
sharing ipd: No