<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/NCT01698528</url>
  </required_header>
  <id_info>
    <org_study_id>CHS 2012-18</org_study_id>
    <nct_id>NCT01698528</nct_id>
  </id_info>
  <brief_title>Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration</brief_title>
  <official_title>Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joslin Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Joslin Diabetes Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if using a diabetes management technology system,&#xD;
      including a tablet computer, to track diabetes care and communicate with a clinician coach (a&#xD;
      doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer&#xD;
      for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology&#xD;
      system with a clinician coach helps more individuals starting basal insulin achieve better&#xD;
      glycemic control with less hypoglycemia compared with standard clinical practice at Joslin&#xD;
      Diabetes Center.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Glycemic Control as Determined by the Change in Absolute HbA1c Level</measure>
    <time_frame>3 months</time_frame>
    <description>The primary outcome of interest is absolute decrease in A1c by end of 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reaching Target of HbA1c ≤ 7%</measure>
    <time_frame>3 months</time_frame>
    <description>Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Average Participation Satisfaction</measure>
    <time_frame>3 months</time_frame>
    <description>The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hypoglycemia</measure>
    <time_frame>3 months</time_frame>
    <description>Number of participants had hypoglycemia during the trial period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Health Care Providers and Subjects Spend on Managing the Insulin Titration</measure>
    <time_frame>3 months</time_frame>
    <description>time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Type II Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tablet Computer</intervention_name>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Toshiba tablet computer</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Has type 2 diabetes, starting on basal insulin therapy&#xD;
&#xD;
          -  Hemoglobin A1c between 9-14%&#xD;
&#xD;
          -  Has Wi-Fi internet connection at home&#xD;
&#xD;
          -  Is willing to monitor blood glucose at least once per day&#xD;
&#xD;
          -  Is willing to inject and self-titrate insulin dose&#xD;
&#xD;
          -  Able to read and communicate in English proficiently&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Has severe visual impairment impacting visual acuity&#xD;
&#xD;
          -  Has severe hearing impairment impacting communication&#xD;
&#xD;
          -  Has Type 1 diabetes&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Alcohol dependency&#xD;
&#xD;
          -  Require multiple daily insulin injections&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Hsu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Joslin Diabetes Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <results_first_submitted>April 20, 2017</results_first_submitted>
  <results_first_submitted_qc>August 16, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 14, 2017</results_first_posted>
  <last_update_submitted>September 28, 2018</last_update_submitted>
  <last_update_submitted_qc>September 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>diabetes technologies</keyword>
  <keyword>telemedicine</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</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="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.8" spread="16.04"/>
                    <measurement group_id="B2" value="53.3" spread="1.88"/>
                    <measurement group_id="B3" value="53.52" spread="13.76"/>
                  </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="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Glycemic Control as Determined by the Change in Absolute HbA1c Level</title>
        <description>The primary outcome of interest is absolute decrease in A1c by end of 3 months.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Control as Determined by the Change in Absolute HbA1c Level</title>
          <description>The primary outcome of interest is absolute decrease in A1c by end of 3 months.</description>
          <units>Percent A1C</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.16" spread="1.54"/>
                    <measurement group_id="O2" value="-2.00" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reaching Target of HbA1c ≤ 7%</title>
        <description>Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reaching Target of HbA1c ≤ 7%</title>
          <description>Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.</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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Average Participation Satisfaction</title>
        <description>The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Average Participation Satisfaction</title>
          <description>The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="11.68"/>
                    <measurement group_id="O2" value="2.05" spread="6.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hypoglycemia</title>
        <description>Number of participants had hypoglycemia during the trial period</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hypoglycemia</title>
          <description>Number of participants had hypoglycemia during the trial 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="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Health Care Providers and Subjects Spend on Managing the Insulin Titration</title>
        <description>time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Health Care Providers and Subjects Spend on Managing the Insulin Titration</title>
          <description>time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108" spread="41"/>
                    <measurement group_id="O2" value="80" spread="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.&#xD;
Tablet Computer</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr William Hsu</name_or_title>
      <organization>Joslin Diabetes Center</organization>
      <phone>617-309-5803</phone>
      <email>william.hsu@joslin.harvard.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/NCT01698528
org study id: CHS 2012-18
nct id: NCT01698528
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if using a diabetes management technology system,
      including a tablet computer, to track diabetes care and communicate with a clinician coach (a
      doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer
      for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology
      system with a clinician coach helps more individuals starting basal insulin achieve better
      glycemic control with less hypoglycemia compared with standard clinical practice at Joslin
      Diabetes Center.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Glycemic Control as Determined by the Change in Absolute HbA1c Level
time frame: 3 months
description: The primary outcome of interest is absolute decrease in A1c by end of 3 months.
measure: Number of Participants Reaching Target of HbA1c ≤ 7%
time frame: 3 months
description: Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
measure: Change in Average Participation Satisfaction
time frame: 3 months
description: The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48, with higher scores indicating greater satisfaction. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.
measure: Number of Participants With Hypoglycemia
time frame: 3 months
description: Number of participants had hypoglycemia during the trial period
measure: Time Health Care Providers and Subjects Spend on Managing the Insulin Titration
time frame: 3 months
description: time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes
arm group label: Intervention Group
arm group type: Experimental
description: The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.
arm group label: Control Group
arm group type: No Intervention
description: The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
intervention type: Device
intervention name: Tablet Computer
arm group label: Intervention Group
other name: Toshiba tablet computer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William Hsu, M.D.
role: Principal Investigator
affiliation: Joslin Diabetes Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 