<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/NCT02980978</url>
  </required_header>
  <id_info>
    <org_study_id>ENHANCED</org_study_id>
    <nct_id>NCT02980978</nct_id>
  </id_info>
  <brief_title>diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)</brief_title>
  <acronym>ENHANCED</acronym>
  <official_title>diEtitiaNs Helping pAtieNts CarE for Diabetes (ENHANCED)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minneapolis Heart Institute Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academy of Nutrition and Dietetics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Minneapolis Heart Institute Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED&#xD;
      randomized control trial. The study is being conducted by the Minneapolis Heart Institute&#xD;
      Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical&#xD;
      Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).&#xD;
&#xD;
      The study will examine the impact of a registered dietitian-led, primary care integrated,&#xD;
      telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual&#xD;
      care. The D5 goals include: blood pressure &lt;140/90 mmHg, taking a statin as appropriate, A1c&#xD;
      &lt;8%, not using tobacco and taking an aspirin as appropriate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals will be invited to attend a baseline visit where they will have lab work done,&#xD;
      anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment.&#xD;
      They will formally consent to participation by signing a study consent form. The same&#xD;
      measures will be collected after completion of the one year study.&#xD;
&#xD;
      Study participants will receive two sessions of free lab work, a diabetes education book, and&#xD;
      brief coaching with a registered dietitian/certified diabetes educator. In addition, those&#xD;
      randomized to the phone coaching will have access to a registered dietitian/certified&#xD;
      diabetes educator on a monthly basis for one year of personalized health coaching for free.&#xD;
      The intent of this coaching is to help individuals achieve diabetes &quot;optimal&quot; care or meeting&#xD;
      all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin&#xD;
      use).&#xD;
&#xD;
      This program is designed to complement usual clinic-based primary care, with coaches&#xD;
      documenting lab, biometrics and medication adjustments in the EHR, along with documenting&#xD;
      phone encounters and communicating directly with patients' PCPs as needed. Documentation in&#xD;
      the EHR uses an order created specifically for the study indicating the patient's research&#xD;
      status.&#xD;
&#xD;
      Lab work required as part of this research study at baseline and 12 months is covered by the&#xD;
      study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month&#xD;
      study visits are the responsibility of the patient and/or their insurance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">November 13, 2018</completion_date>
  <primary_completion_date type="Actual">December 13, 2017</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>A1c (Laboratory Assessment)</measure>
    <time_frame>1 year</time_frame>
    <description>The count of participants represents the number of individuals meeting A1c less than 8% at follow up</description>
  </primary_outcome>
  <other_outcome>
    <measure>Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)</measure>
    <time_frame>1 year</time_frame>
    <description>The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>Tobacco Use (Self-reported Questionnaire)</measure>
    <time_frame>1 year</time_frame>
    <description>The count of participants represents those not using tobacco at follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>Statin Use (as Noted in EMR)</measure>
    <time_frame>1 year</time_frame>
    <description>The count of participants represents those taking a statin as indicated at follow up</description>
  </other_outcome>
  <other_outcome>
    <measure>Aspirin Use (as Noted in EMR)</measure>
    <time_frame>1 year</time_frame>
    <description>The count of participants represents taking aspirin as indicated at follow up</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coaching</intervention_name>
    <description>Focus on nutrition, activity and appropriate medication use and adherence</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Type 2 Diabetes&#xD;
&#xD;
          2. Individuals who are not meeting 3 or more D5 goals,&#xD;
&#xD;
          3. Have had a visit with a provider within the last 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Type 1 Diabetes&#xD;
&#xD;
          2. Chronic kidney disease (GFR &lt;30)&#xD;
&#xD;
          3. HIV&#xD;
&#xD;
          4. Institutional residence&#xD;
&#xD;
          5. Major cognitive or language barrier (as determined by program enrollment staff)&#xD;
&#xD;
          6. Other active end-stage disease (e.g., late stage cancer or pulmonary disease)&#xD;
&#xD;
          7. Actively receiving cancer treatment&#xD;
&#xD;
          8. Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Miedema, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minneapolis Heart Institute Foundation</affiliation>
  </overall_official>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <results_first_submitted>May 30, 2019</results_first_submitted>
  <results_first_submitted_qc>May 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 29, 2019</results_first_posted>
  <last_update_submitted>May 30, 2019</last_update_submitted>
  <last_update_submitted_qc>May 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT02980978/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</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="60"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="118"/>
          </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="48"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="59.8" spread="10.2"/>
                    <measurement group_id="B2" value="60.0" spread="8.66"/>
                    <measurement group_id="B3" value="59.9" spread="9.43"/>
                  </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="28"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="65"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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="60"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>A1c (Laboratory Assessment)</title>
        <description>The count of participants represents the number of individuals meeting A1c less than 8% at follow up</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</description>
          </group>
        </group_list>
        <measure>
          <title>A1c (Laboratory Assessment)</title>
          <description>The count of participants represents the number of individuals meeting A1c less than 8% at follow up</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="54"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)</title>
        <description>The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)</title>
          <description>The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up</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="54"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Tobacco Use (Self-reported Questionnaire)</title>
        <description>The count of participants represents those not using tobacco at follow up</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</description>
          </group>
        </group_list>
        <measure>
          <title>Tobacco Use (Self-reported Questionnaire)</title>
          <description>The count of participants represents those not using tobacco at follow up</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="54"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Statin Use (as Noted in EMR)</title>
        <description>The count of participants represents those taking a statin as indicated at follow up</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</description>
          </group>
        </group_list>
        <measure>
          <title>Statin Use (as Noted in EMR)</title>
          <description>The count of participants represents those taking a statin as indicated at follow up</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="54"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Aspirin Use (as Noted in EMR)</title>
        <description>The count of participants represents taking aspirin as indicated at follow up</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</description>
          </group>
        </group_list>
        <measure>
          <title>Aspirin Use (as Noted in EMR)</title>
          <description>The count of participants represents taking aspirin as indicated at follow up</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="54"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals&#xD;
Coaching: Focus on nutrition, activity and appropriate medication use and adherence</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need</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="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </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="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Population Health Program Manager</name_or_title>
      <organization>Minneapolis Heart Institute Foundation</organization>
      <phone>612-863-4222</phone>
      <email>gbenson@mhif.org</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/NCT02980978
org study id: ENHANCED
nct id: NCT02980978
lead sponsor: 
collaborator: 
has dmc: No
This study aims to randomly assign individuals with type 2 diabetes into the ENHANCED
      randomized control trial. The study is being conducted by the Minneapolis Heart Institute
      Foundation (MHIF) and will have two study sites 1) Hutchinson Health and 2) New Ulm Medical
      Center. The study is primarily funded through the Academy of Nutrition and Dietetics (AND).

      The study will examine the impact of a registered dietitian-led, primary care integrated,
      telemedicine program on diabetes care measures (the 'D5') over one year as compared to usual
      care. The D5 goals include: blood pressure <140/90 mmHg, taking a statin as appropriate, A1c
      <8%, not using tobacco and taking an aspirin as appropriate.
Individuals will be invited to attend a baseline visit where they will have lab work done,
      anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment.
      They will formally consent to participation by signing a study consent form. The same
      measures will be collected after completion of the one year study.

      Study participants will receive two sessions of free lab work, a diabetes education book, and
      brief coaching with a registered dietitian/certified diabetes educator. In addition, those
      randomized to the phone coaching will have access to a registered dietitian/certified
      diabetes educator on a monthly basis for one year of personalized health coaching for free.
      The intent of this coaching is to help individuals achieve diabetes "optimal" care or meeting
      all 5 Diabetes Care measures (blood glucose, blood pressure, tobacco use, statin and aspirin
      use).

      This program is designed to complement usual clinic-based primary care, with coaches
      documenting lab, biometrics and medication adjustments in the EHR, along with documenting
      phone encounters and communicating directly with patients' PCPs as needed. Documentation in
      the EHR uses an order created specifically for the study indicating the patient's research
      status.

      Lab work required as part of this research study at baseline and 12 months is covered by the
      study. Any lab work and/or medication co-pays or fees outside of the baseline and 12 month
      study visits are the responsibility of the patient and/or their insurance
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: A1c (Laboratory Assessment)
time frame: 1 year
description: The count of participants represents the number of individuals meeting A1c less than 8% at follow up
measure: Blood Pressure (Calibrated Cuff Measurement- Average of 3 Readings)
time frame: 1 year
description: The count of participants represents the number of individuals meeting blood pressure less than 140/90 at follow up
measure: Tobacco Use (Self-reported Questionnaire)
time frame: 1 year
description: The count of participants represents those not using tobacco at follow up
measure: Statin Use (as Noted in EMR)
time frame: 1 year
description: The count of participants represents those taking a statin as indicated at follow up
measure: Aspirin Use (as Noted in EMR)
time frame: 1 year
description: The count of participants represents taking aspirin as indicated at follow up
arm group label: Intervention
arm group type: Experimental
description: Individuals assigned to the intervention group will have supplemental care provided by a registered dietitian/certified diabetes educator which includes counseling on lifestyle to improve diabetes and overall health. Additionally, individuals in this group may be started on medications (or adjustments to current medications) for blood pressure, cholesterol or blood glucose to meet diabetes care goals
arm group label: Standard of Care
arm group type: No Intervention
description: Individuals will be followed by their Primary Care Provider as standard of care and per usual clinical need
intervention type: Behavioral
intervention name: Coaching
description: Focus on nutrition, activity and appropriate medication use and adherence
arm group label: Intervention
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Miedema, MD
role: Principal Investigator
affiliation: Minneapolis Heart Institute Foundation
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 