<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/NCT01698008</url>
  </required_header>
  <id_info>
    <org_study_id>396-12-FB</org_study_id>
    <nct_id>NCT01698008</nct_id>
  </id_info>
  <brief_title>Effect of Mobile Phone Telemedicine on Diabetes Care</brief_title>
  <official_title>Effect of Mobile Phone Telemedicine on Diabetes Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nebraska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nebraska</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adult patients with diabetes on insulin are eligible for the study. They will be randomized&#xD;
      to a group using standard of care communication and a group using an I phone intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are&#xD;
      between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in the&#xD;
      study. Subjects will be randomized to two groups - iPhone versus standard of care and seen in&#xD;
      our clinic at an initial/baseline and three month clinical visit. The control group will&#xD;
      e-mail, fax, or call their blood glucose log results once a month for an insulin regimen&#xD;
      adjustment through verbal communication with a certified diabetic educator once a month as is&#xD;
      already implemented at the Diabetes Center. This group will be compared to the intervention&#xD;
      group who will submit their blood glucose log results through an iPhone mobile application,&#xD;
      called Diabetes Doctor, once a month for an insulin regimen adjustment by a physician with a&#xD;
      text message response. The two groups will have their HbA1c, hypoglycemic events, blood&#xD;
      glucose dispersion compliance, quality of life, usability and satisfaction with the use of a&#xD;
      mobile application will be assessed at each visit with surveys.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">September 25, 2013</completion_date>
  <primary_completion_date type="Actual">September 25, 2013</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>One group is standard of care. The other is given the opportunity to use a new mobile app for reporting blood sugars.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence for Improved Diabetic Care With Mobile Phone Application Use</measure>
    <time_frame>Six months</time_frame>
    <description>Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Mobile application Diabetes Doctor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will send in blood glucoses once a month using the mobile phone app, Diabetes Doctor. All subjects will be evaluated at initial, 3 month, and 6 month visits. They will receive HbA1c on each visit. After 3 months, a Diabetes Quality of Life (QOL) survey will be completed. A Usability and Satisfaction of Diabetes Doctor (USDD) survey will also be obtained. At the 3 month visit, they will also be given the chance to discontinue the mobile app and switch to standard of care. At 6 months, all mobile app users will complete the USDD and satisfaction and QOL survey. If they are not using the mobile app, then they will complete the QOL survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The standard of care arm will not use the mobile application Diabetes Doctor to communicate with their physician about their blood sugars. They will attend clinic visits and have evaluations initially, and at 3 and 6 months. They will also receive a HbAIc at each visit. They will do the same QOL survey at 3 months. At 6 months, they will be given the QOL survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diabetes Doctor Mobile app</intervention_name>
    <description>Diabetes Doctor is a mobile application software. The mobile phone application allows a subject to register blood glucose values obtained from their fingerstick glucose meter readings, the type and amount of insulin they are administering, any notes they would like to document, and the date and time of each entry. All data will be entered by the subject manually. The data will be submitted through encryption coded private servers and can be retrievable by a physician on a password protected website for privacy. A physician will evaluate this information to recommend a change of the subject's insulin regimen. The recommended insulin regimen will be delivered to the patient using the same website and received by the subject on the same mobile application software.</description>
    <arm_group_label>Mobile application Diabetes Doctor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 or type 2 Diabetes Mellitus on insulin basal/bolus injection&#xD;
&#xD;
          -  Own and are able to operate an iPhone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetics using only oral medications&#xD;
&#xD;
          -  Do not own or know how to operate an iPhone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Whitney S Goldner, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>January 29, 2018</results_first_submitted>
  <results_first_submitted_qc>March 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 2, 2018</results_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nebraska</investigator_affiliation>
    <investigator_full_name>Whitney Goldner, 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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mobile Application Diabetes Doctor</title>
          <description>This group was given the opportunity to use the mobile app: Diabetes Doctor to send in blood sugars to communicate with their physician.</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care Group</title>
          <description>This group continued to communicate with their physician regarding their blood sugars as per standard of care and routine clinic follow ups. No intervention was made.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All patients have type 1 diabetes.</population>
      <group_list>
        <group group_id="B1">
          <title>Mobile Application Diabetes Doctor</title>
          <description>The intervention group sent blood glucoses once a month using the mobile phone app, Diabetes Doctor. Subjects were seen at initial, 3 month, and 6 month visits. They received HbA1c on each visit. After 3 months, a Diabetes Quality of Life (QOL)survey was completed. A Usability and Satisfaction of Diabetes Doctor (USDD) survey was given to assess use of the mobile app. At the 3 month interval the control group will be given the opportunity to use the mobile application. QOL and USDD was given at the conclusion of the study.</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care Group</title>
          <description>This group did not use the mobile app to communicate with their physician about their blood sugars. They continued with their current care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Evidence for Improved Diabetic Care With Mobile Phone Application Use</title>
        <description>Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.</description>
        <time_frame>Six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Application Diabetes Doctor</title>
            <description>This group was given the opportunity to use the mobile app Diabetes Doctor to communicate with their physician about their blood sugars.</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>This group followed standard of care, did not use the mobile app Diabetes Doctor.</description>
          </group>
        </group_list>
        <measure>
          <title>Evidence for Improved Diabetic Care With Mobile Phone Application Use</title>
          <description>Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The data were collected for the duration of the study, 6 months.</time_frame>
      <desc>no difference than clinicaltrials.gov</desc>
      <group_list>
        <group group_id="E1">
          <title>Mobile Application Diabetes Doctor</title>
          <description>This group used the mobile app Diabetes Doctor to communicate with their physicians about their blood sugars.</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>This group did not use the mobile app Diabetes Doctor to communicate with their physicians.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Overall, there were difficulties with this study. We only had a small number of patients interested in participating and those that were given standard of care treatment did not continue on with the study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Whitney Goldner, MD</name_or_title>
      <organization>University of Nebraska Medical Center</organization>
      <phone>402-559-3579</phone>
      <email>wgoldner@unmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01698008
org study id: 396-12-FB
nct id: NCT01698008
lead sponsor: 
has dmc: Yes
Adult patients with diabetes on insulin are eligible for the study. They will be randomized
      to a group using standard of care communication and a group using an I phone intervention.
Type 1 or type 2 diabetes mellitus subjects who know how to operate and own an iPhone, are
      between the age of 19 to 75, and are on a basal/bolus insulin regimen will be included in the
      study. Subjects will be randomized to two groups - iPhone versus standard of care and seen in
      our clinic at an initial/baseline and three month clinical visit. The control group will
      e-mail, fax, or call their blood glucose log results once a month for an insulin regimen
      adjustment through verbal communication with a certified diabetic educator once a month as is
      already implemented at the Diabetes Center. This group will be compared to the intervention
      group who will submit their blood glucose log results through an iPhone mobile application,
      called Diabetes Doctor, once a month for an insulin regimen adjustment by a physician with a
      text message response. The two groups will have their HbA1c, hypoglycemic events, blood
      glucose dispersion compliance, quality of life, usability and satisfaction with the use of a
      mobile application will be assessed at each visit with surveys.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One group is standard of care. The other is given the opportunity to use a new mobile app for reporting blood sugars.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Evidence for Improved Diabetic Care With Mobile Phone Application Use
time frame: Six months
description: Satisfaction and usability was evaluated with a survey for those subjects who used the mobile phone application at the 3 and 6 months period.
arm group label: Mobile application Diabetes Doctor
arm group type: Experimental
description: The intervention group will send in blood glucoses once a month using the mobile phone app, Diabetes Doctor. All subjects will be evaluated at initial, 3 month, and 6 month visits. They will receive HbA1c on each visit. After 3 months, a Diabetes Quality of Life (QOL) survey will be completed. A Usability and Satisfaction of Diabetes Doctor (USDD) survey will also be obtained. At the 3 month visit, they will also be given the chance to discontinue the mobile app and switch to standard of care. At 6 months, all mobile app users will complete the USDD and satisfaction and QOL survey. If they are not using the mobile app, then they will complete the QOL survey.
arm group label: Standard of Care
arm group type: No Intervention
description: The standard of care arm will not use the mobile application Diabetes Doctor to communicate with their physician about their blood sugars. They will attend clinic visits and have evaluations initially, and at 3 and 6 months. They will also receive a HbAIc at each visit. They will do the same QOL survey at 3 months. At 6 months, they will be given the QOL survey.
intervention type: Other
intervention name: Diabetes Doctor Mobile app
description: Diabetes Doctor is a mobile application software. The mobile phone application allows a subject to register blood glucose values obtained from their fingerstick glucose meter readings, the type and amount of insulin they are administering, any notes they would like to document, and the date and time of each entry. All data will be entered by the subject manually. The data will be submitted through encryption coded private servers and can be retrievable by a physician on a password protected website for privacy. A physician will evaluate this information to recommend a change of the subject's insulin regimen. The recommended insulin regimen will be delivered to the patient using the same website and received by the subject on the same mobile application software.
arm group label: Mobile application Diabetes Doctor
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Whitney S Goldner, M.D.
role: Principal Investigator
affiliation: University of Nebraska
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nebraska
investigator full name: Whitney Goldner, MD
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Overall, there were difficulties with this study. We only had a small number of patients interested in participating and those that were given standard of care treatment did not continue on with the study.
point of contact: 