<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/NCT01715649</url>
  </required_header>
  <id_info>
    <org_study_id>1208042ex</org_study_id>
    <nct_id>NCT01715649</nct_id>
  </id_info>
  <brief_title>Telehealth Remote Patient Monitoring Study in People With Type 2 Diabetes</brief_title>
  <official_title>Evaluation of a Telehealth Intervention Combining Structured Self-Monitoring of Blood Glucose and Nurse Care Coordination Among People With Type 2 Diabetes Noninsulin-Treated</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sutter Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LifeScan</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sutter Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Telehealth remote patient monitoring is a means of using communications technology - such as&#xD;
      telephones, computers, and the Internet - to connect patients remotely with their healthcare&#xD;
      team from their homes. The investigators hope to learn more about improving healthy behaviors&#xD;
      and blood glucose among persons with diabetes using telehealth remote patient monitoring&#xD;
      technology to connect directly with nurse care coordinators.&#xD;
&#xD;
      The purpose of this study is to evaluate a process for improving blood glucose and healthy&#xD;
      behaviors among people with type 2 diabetes using telehealth remote patient monitoring&#xD;
      technology with nurse care coordinators. Some of the people in this study will work with a&#xD;
      nurse care coordinator who will review your blood glucose weekly and call you at home every&#xD;
      month for 3 months, while some of the people in this study will simply receive their normal&#xD;
      care. At the end of the study, every participant will be asked questions about how they feel&#xD;
      about their health care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>Lab test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Empowerment</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Diabetes Empowerment Scale completed by survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior Change</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Summary of Diabetes Self-Care Behaviors scale completed by survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge</measure>
    <time_frame>Change from baseline to 3 months</time_frame>
    <description>Michigan Diabetes Knowledge Test completed by survey</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Feasibility of incorporating the intervention into the existing program</measure>
    <time_frame>3 months</time_frame>
    <description>Will include # of participants that complete intervention, #of nurse hours required to analyze data and interact with participant,and number of technology issues impacting use</description>
  </other_outcome>
  <other_outcome>
    <measure>Participant engagement with telehealth technology</measure>
    <time_frame>3 months</time_frame>
    <description># of participants that complete the 12 week program, # of participants that upload the blood glucose meter values to the technology</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Control-usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Nurse care coordination in a telephonic diabetes disease management program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention paired testing and remote monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Telehealth remote patient monitoring, structured blood glucose and usual care Paired testing-weekly remote monitoring Data analysis Virtual visits in EHR</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose</intervention_name>
    <description>In the intervention arm you will test your blood glucose 2 times a day (before and after a meal, activity or other event) using the glucose meter provided to you for use in this study and connect it to the Telehealth Unit. Every week the study team will review your blood glucose levels through the remote patient monitoring secure portal and send you a reminder through the Telehealth Unit with suggestions based on your blood glucose patterns. Once every month a study nurse will call you to review your blood glucose goals and discuss how you may be able to make changes in your health behaviors to improve your blood glucose levels. The study team will work with you to help you make changes to your behaviors that may improve your blood glucose.</description>
    <arm_group_label>Intervention paired testing and remote monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in diabetes disease management program&#xD;
&#xD;
          -  ages 30-70&#xD;
&#xD;
          -  HbA1c between 7.5% and 10.9% in the previous six months&#xD;
&#xD;
          -  an Internet or 3G connection and email address;&#xD;
&#xD;
          -  a working phone line (land line or cellular); and&#xD;
&#xD;
          -  ability to read and understand the English language.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  taking insulin;&#xD;
&#xD;
          -  inability to independently engage in self-management behaviors (diagnosis of dementia,&#xD;
             severe depression, schizophrenia, or cognitive impairment);&#xD;
&#xD;
          -  severe complications, which would preclude achieving an HbA1c goal of 7% including&#xD;
             diagnosis of the following:&#xD;
&#xD;
          -  severe stroke;&#xD;
&#xD;
          -  heart failure;&#xD;
&#xD;
          -  end-stage renal disease;&#xD;
&#xD;
          -  kidney dialysis; and&#xD;
&#xD;
          -  legally blind.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sutter Health</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95833</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>November 17, 2014</last_update_submitted>
  <last_update_submitted_qc>November 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sutter Health</investigator_affiliation>
    <investigator_full_name>Deborah Greenwood</investigator_full_name>
    <investigator_title>Diabetes Clinical Nurse Specialist</investigator_title>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>self-management</keyword>
  <keyword>remote patient monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01715649
org study id: 1208042ex
nct id: NCT01715649
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
Telehealth remote patient monitoring is a means of using communications technology - such as
      telephones, computers, and the Internet - to connect patients remotely with their healthcare
      team from their homes. The investigators hope to learn more about improving healthy behaviors
      and blood glucose among persons with diabetes using telehealth remote patient monitoring
      technology to connect directly with nurse care coordinators.

      The purpose of this study is to evaluate a process for improving blood glucose and healthy
      behaviors among people with type 2 diabetes using telehealth remote patient monitoring
      technology with nurse care coordinators. Some of the people in this study will work with a
      nurse care coordinator who will review your blood glucose weekly and call you at home every
      month for 3 months, while some of the people in this study will simply receive their normal
      care. At the end of the study, every participant will be asked questions about how they feel
      about their health care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hemoglobin A1c
time frame: Change from baseline to 6 months
description: Lab test
measure: Empowerment
time frame: Change from baseline to 3 months
description: Diabetes Empowerment Scale completed by survey
measure: Behavior Change
time frame: Change from baseline to 3 months
description: Summary of Diabetes Self-Care Behaviors scale completed by survey
measure: Knowledge
time frame: Change from baseline to 3 months
description: Michigan Diabetes Knowledge Test completed by survey
measure: Feasibility of incorporating the intervention into the existing program
time frame: 3 months
description: Will include # of participants that complete intervention, #of nurse hours required to analyze data and interact with participant,and number of technology issues impacting use
measure: Participant engagement with telehealth technology
time frame: 3 months
description: # of participants that complete the 12 week program, # of participants that upload the blood glucose meter values to the technology
arm group label: Control-usual care
arm group type: No Intervention
description: Nurse care coordination in a telephonic diabetes disease management program
arm group label: Intervention paired testing and remote monitoring
arm group type: Experimental
description: Telehealth remote patient monitoring, structured blood glucose and usual care Paired testing-weekly remote monitoring Data analysis Virtual visits in EHR
intervention type: Behavioral
intervention name: Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose
description: In the intervention arm you will test your blood glucose 2 times a day (before and after a meal, activity or other event) using the glucose meter provided to you for use in this study and connect it to the Telehealth Unit. Every week the study team will review your blood glucose levels through the remote patient monitoring secure portal and send you a reminder through the Telehealth Unit with suggestions based on your blood glucose patterns. Once every month a study nurse will call you to review your blood glucose goals and discuss how you may be able to make changes in your health behaviors to improve your blood glucose levels. The study team will work with you to help you make changes to your behaviors that may improve your blood glucose.
arm group label: Intervention paired testing and remote monitoring
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sutter Health
investigator full name: Deborah Greenwood
investigator title: Diabetes Clinical Nurse Specialist
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2