<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/NCT01722643</url>
  </required_header>
  <id_info>
    <org_study_id>23559</org_study_id>
    <secondary_id>1DP3HD076602-01</secondary_id>
    <nct_id>NCT01722643</nct_id>
  </id_info>
  <brief_title>Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes</brief_title>
  <official_title>Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this project is to develop a novel family friendly intervention that will&#xD;
      help teens with poor metabolic control of their type 1 diabetes increase and sustain daily&#xD;
      self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic&#xD;
      control has long-term health implications. This project will provide important information&#xD;
      regarding new effective ways to improve outcomes among teens with poorly controlled type 1&#xD;
      diabetes.&#xD;
&#xD;
      Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and&#xD;
      maintain glucose control, and (2) improve decision making (improve executive function and&#xD;
      reduce delay discounting), which will predict treatment outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 diabetes in adolescents is a significant medical condition associated with high&#xD;
      economic costs and increased mortality, and its incidence is increasing. Unfortunately,&#xD;
      adolescents show poorer adherence to self monitoring of blood glucose (SMBG) recommendations&#xD;
      and poorer metabolic control than adults. Although some individual and family-based&#xD;
      interventions have shown promise in improving metabolic control, there is a critical need to&#xD;
      develop more effective interventions. The overall goal of this DP3 project is to develop a&#xD;
      new innovative intervention that targets decision making to help teens with poor diabetic&#xD;
      metabolic control increase the frequency of SMBG and improve HbA1c. The target population&#xD;
      will be teens aged 13-17 with type 1 diabetes and HbA1c &gt;8%. Based on our prior work and a&#xD;
      conceptual model, the proposed study will develop and pilot test a novel, multifaceted,&#xD;
      developmentally appropriate intervention aimed at improving adolescent decision making. An&#xD;
      integrated set of components target adolescents' need for frequent positive feedback,&#xD;
      improved future orientation, and motivational support. While past research indicates that&#xD;
      behavioral interventions are frequently more successful when they include multiple elements,&#xD;
      no previous intervention has combined multiple empirically-based components that target key&#xD;
      decision making levers in one intervention. This new intervention, called MAxIM (MotivAtion,&#xD;
      Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based&#xD;
      treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to&#xD;
      enhance behavior change; 2) financial incentives for daily blood glucose testing and parental&#xD;
      monitoring to provide frequent positive feedback; and 3) working memory training (WMT), an&#xD;
      efficacious method for strengthening specific cognitive processes that support&#xD;
      decision-making and future orientation. The interventions will be delivered to families at&#xD;
      home via the internet to increase the reach of the intervention to families living distant&#xD;
      from their treating endocrinologist. MAxIM will be teen and parent friendly and designed to&#xD;
      increase engagement and compliance with the intervention. Primary hypotheses are that MAxIM&#xD;
      will: (1) help teens improve and maintain glucose control, and (2) improve decision making&#xD;
      (improve executive function and reduce delay discounting), which will predict treatment&#xD;
      outcome. The unique set of interventions holds promise for improving adherence by affecting&#xD;
      multiple basic mechanisms that determine poor decision making. The project will develop a&#xD;
      novel, highly transportable, home based intervention designed to maximize and sustain HbA1c&#xD;
      reductions and SMBG frequency over time in adolescents. Innovations include the targeting of&#xD;
      multiple levers specific to adolescent decision making, use of technology to deliver the&#xD;
      intervention to families at home, and testing cognitive predictors of treatment outcome for&#xD;
      teens with diabetes. Successful achievement of this study's aims will bring the field closer&#xD;
      to a cost effective, long-lasting intervention to improve outcomes among these high-risk&#xD;
      youth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>HbA1c at 12 Months</measure>
    <time_frame>12 months following enrollment</time_frame>
    <description>Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment</measure>
    <time_frame>12 months following enrollment</time_frame>
    <description>Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>MAxIM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>MAxIM</intervention_name>
    <description>This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.</description>
    <arm_group_label>MAxIM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  13-17 years old&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes&#xD;
&#xD;
          -  Average HbA1c &gt; or = to 8% for the past 6 months (mean of two values)&#xD;
&#xD;
          -  Most recent HbA1c is &gt; or = to 8%&#xD;
&#xD;
          -  Duration of disease is &gt; 18 months&#xD;
&#xD;
          -  Teen must live at home&#xD;
&#xD;
          -  Family must have broadband internet in the home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy/breast feeding&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Severe medical or psychiatric illness that will limit participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Stanger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dartmouth College</name>
      <address>
        <city>Hanover</city>
        <state>New Hampshire</state>
        <zip>03755</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>April 4, 2018</results_first_submitted>
  <results_first_submitted_qc>May 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2018</results_first_posted>
  <last_update_submitted>May 4, 2018</last_update_submitted>
  <last_update_submitted_qc>May 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Catherine Stanger</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MAxIM</title>
          <description>This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MAxIM</title>
          <description>This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.</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="30"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="61"/>
          </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="15.2" spread="1.4"/>
                    <measurement group_id="B2" value="14.9" spread="1.5"/>
                    <measurement group_id="B3" value="15.1" spread="1.4"/>
                  </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="11"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="60"/>
                  </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>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="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>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="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HbA1c</title>
          <units>percentage glycated hemoglobin</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.1" spread="1.0"/>
                    <measurement group_id="B2" value="9.2" spread="0.9"/>
                    <measurement group_id="B3" value="9.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>HbA1c at 12 Months</title>
        <description>Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c</description>
        <time_frame>12 months following enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MAxIM</title>
            <description>This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>HbA1c at 12 Months</title>
          <description>Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c</description>
          <units>percentage glycated hemoglobin</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.73" spread="0.18"/>
                    <measurement group_id="O2" value="9.29" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment</title>
        <description>Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.</description>
        <time_frame>12 months following enrollment</time_frame>
        <population>1 participant in the MaxIM arm and 1 participant in the Usual Care arm did not provide meter data at 12 months so do not have data for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>MAxIM</title>
            <description>This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment</title>
          <description>Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.</description>
          <population>1 participant in the MaxIM arm and 1 participant in the Usual Care arm did not provide meter data at 12 months so do not have data for this outcome.</population>
          <units>readings per day</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.75" spread=".33"/>
                    <measurement group_id="O2" value="3.56" spread=".33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>Adverse events were collected at each assessment through 12 months via the Health Services Utilization form (Huang, E. S., O'Grady, M., Basu, A., Winn, A., John, P., Lee, J., ... &amp; Wysocki, T. (2010). The cost-effectiveness of continuous glucose monitoring in type 1 diabetes. Diabetes care, 33(6), 1269-1274.)</desc>
      <group_list>
        <group group_id="E1">
          <title>MAxIM</title>
          <description>This intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual Care reflects the standard treatment currently provided for type 1 diabetes. Teens will be followed by their treating endocrinologist and receive standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ER visit with or without hospitalization for low blood sugar</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>ER visit with or without hospitalization for high blood sugar</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Severe low blood sugar event requiring assistance to treat</sub_title>
                <counts group_id="E1" events="28" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </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>Dr. Catherine Stanger</name_or_title>
      <organization>Dartmouth-Hitchcock</organization>
      <phone>603-646-7023</phone>
      <email>catherine.stanger@dartmouth.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/NCT01722643
org study id: 23559
secondary id: 1DP3HD076602-01
nct id: NCT01722643
lead sponsor: 
collaborator: 
has dmc: Yes
The overall goal of this project is to develop a novel family friendly intervention that will
      help teens with poor metabolic control of their type 1 diabetes increase and sustain daily
      self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic
      control has long-term health implications. This project will provide important information
      regarding new effective ways to improve outcomes among teens with poorly controlled type 1
      diabetes.

      Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and
      maintain glucose control, and (2) improve decision making (improve executive function and
      reduce delay discounting), which will predict treatment outcome.
Type 1 diabetes in adolescents is a significant medical condition associated with high
      economic costs and increased mortality, and its incidence is increasing. Unfortunately,
      adolescents show poorer adherence to self monitoring of blood glucose (SMBG) recommendations
      and poorer metabolic control than adults. Although some individual and family-based
      interventions have shown promise in improving metabolic control, there is a critical need to
      develop more effective interventions. The overall goal of this DP3 project is to develop a
      new innovative intervention that targets decision making to help teens with poor diabetic
      metabolic control increase the frequency of SMBG and improve HbA1c. The target population
      will be teens aged 13-17 with type 1 diabetes and HbA1c >8%. Based on our prior work and a
      conceptual model, the proposed study will develop and pilot test a novel, multifaceted,
      developmentally appropriate intervention aimed at improving adolescent decision making. An
      integrated set of components target adolescents' need for frequent positive feedback,
      improved future orientation, and motivational support. While past research indicates that
      behavioral interventions are frequently more successful when they include multiple elements,
      no previous intervention has combined multiple empirically-based components that target key
      decision making levers in one intervention. This new intervention, called MAxIM (MotivAtion,
      Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based
      treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to
      enhance behavior change; 2) financial incentives for daily blood glucose testing and parental
      monitoring to provide frequent positive feedback; and 3) working memory training (WMT), an
      efficacious method for strengthening specific cognitive processes that support
      decision-making and future orientation. The interventions will be delivered to families at
      home via the internet to increase the reach of the intervention to families living distant
      from their treating endocrinologist. MAxIM will be teen and parent friendly and designed to
      increase engagement and compliance with the intervention. Primary hypotheses are that MAxIM
      will: (1) help teens improve and maintain glucose control, and (2) improve decision making
      (improve executive function and reduce delay discounting), which will predict treatment
      outcome. The unique set of interventions holds promise for improving adherence by affecting
      multiple basic mechanisms that determine poor decision making. The project will develop a
      novel, highly transportable, home based intervention designed to maximize and sustain HbA1c
      reductions and SMBG frequency over time in adolescents. Innovations include the targeting of
      multiple levers specific to adolescent decision making, use of technology to deliver the
      intervention to families at home, and testing cognitive predictors of treatment outcome for
      teens with diabetes. Successful achievement of this study's aims will bring the field closer
      to a cost effective, long-lasting intervention to improve outcomes among these high-risk
      youth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: HbA1c at 12 Months
time frame: 12 months following enrollment
description: Glycated hemoglobin test (HbA1c) measures the non-enzymatic glycation status of hemoglobin expressed in percentage points. Analyses control for pump status, diabetes duration and baseline HbA1c
measure: Daily Frequency of Self Monitoring of Blood Glucose Checks 12 Months Following Enrollment
time frame: 12 months following enrollment
description: Participants will use a glucometer to self-monitor blood glucose daily. Readings from the glucometer will be uploaded at each session and at the follow up visits. The glucometer records the blood glucose level as well as a date/time stamp over a 90 day period. To assess the daily testing frequency, the total number of blood glucose tests a day during the 14 days prior to each assessment will be recorded from the study provided glucometer.
arm group label: MAxIM
arm group type: Experimental
description: This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
arm group label: Usual Care
arm group type: Active Comparator
description: Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
intervention type: Behavioral
intervention name: MAxIM
description: This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
arm group label: MAxIM
intervention type: Behavioral
intervention name: Usual Care
description: Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
last name: Catherine Stanger, PhD
role: Principal Investigator
affiliation: Dartmouth College
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Catherine Stanger
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 