<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/NCT03765164</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00024791</org_study_id>
    <nct_id>NCT03765164</nct_id>
  </id_info>
  <brief_title>Glucose Control Using 1,5-AG Testing</brief_title>
  <acronym>GLUCAR</acronym>
  <official_title>Glucose Control Using 1,5-AG: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qure Healthcare, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlycoMark, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Qure Healthcare, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glycemic excursions (temporary increases in blood glucose) are associated with health&#xD;
      complications. Standard tests for diabetes (e.g. random blood sugar and HbA1c) do not test&#xD;
      for these excursions despite their association with several health complications. GlycoMark's&#xD;
      1,5-anhydroglucitol (1,5-AG) is a validated indicator of glucose excursions in addition to&#xD;
      short-term (1-2 weeks) hyperglycemia.&#xD;
&#xD;
      This study is a pre-post, two-round randomized controlled study of a nationally&#xD;
      representative sample of primary care physicians. Investigators will assess whether physician&#xD;
      participants are able to identify and address glycemic variability and hyperglycemia in their&#xD;
      patients and, when given access to GlycoMark assay results, improve their patient management&#xD;
      decisions by taking steps to optimize glycemic control, and reduce unnecessary resource&#xD;
      utilization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nearly half of the adult population, 114 million Americans, are diagnosed with diabetes or&#xD;
      pre-diabetes, making it one of the most important public and personal health problems.&#xD;
      Diabetes is the 7th leading cause of death in America and a contributing factor in many more&#xD;
      deaths and lost days of productivity. Its complications include vascular disease,&#xD;
      cardiovascular disease, stroke and dementia. The cost of diabetes care and its complications&#xD;
      lead to $176 billion in direct medical costs and $69 billion in reduced productivity. With an&#xD;
      over 2-fold increase in diabetes prevalence in the past two decades and an estimated 1.5&#xD;
      million new cases expected annually, it is clinically and economically critical for this&#xD;
      condition to be managed appropriately.&#xD;
&#xD;
      Diabetes treatment programs focus on controlling hyperglycemia (random glucose &gt; 200 mg/dL)&#xD;
      without causing hypoglycemia (glucose &lt; 70 mg/dL). Glucose control is determined in a number&#xD;
      of ways in current clinical practice. Immediate and fasting blood sugars are determined in&#xD;
      routine chemistry tests. The standard measure of long-term diabetes control, HbA1c testing,&#xD;
      provides a reliable reading of average blood glucose levels over a 2-3-month period. In&#xD;
      patients with high HbA1c levels, HbA1c measurement guides management decisions and helps the&#xD;
      clinician bring the long-term glucose levels under control in poorly controlled diabetic&#xD;
      patients. Random blood sugars and HbA1c is limited in that they do not reflect glycemic&#xD;
      control in intervals greater than the past few hours and 2-3 months. In particular, they do&#xD;
      not provide an indication of frequent, temporary increases in blood glucose, termed glycemic&#xD;
      excursions, which have been independently associated with several health complications. Since&#xD;
      it takes months for HbA1c levels to stabilize, HbA1c levels are also not helpful for patients&#xD;
      starting medication or changing drug therapy.&#xD;
&#xD;
      1,5-anhydroglucitol (1,5-AG) is a molecule found in the blood and is a validated indicator of&#xD;
      glucose excursions and short-term (1-2 weeks) hyperglycemia. In healthy patients without&#xD;
      diabetes, or those with well-controlled diabetes, 1,5-AG is maintained at a steady state in&#xD;
      the blood. However, during glycemic excursions, the molecule is actively purged from the body&#xD;
      through the urine. Cleared by the FDA in 2003, the GlycoMark assay measures 1,5-AG levels in&#xD;
      the blood. Low levels of 1,5-AG indicate the presence of potentially harmful glycemic&#xD;
      excursion over the last 1 to 2 weeks, which may have been missed during random blood glucose&#xD;
      testing and not sensitively detected by HbA1c.&#xD;
&#xD;
      GlycoMark testing provides clinical details on peak glucose levels, daily spikes, and&#xD;
      response to drugs, including short term effects, of hypoglycemic agents that are otherwise&#xD;
      not available, giving physicians a more complete understanding of their patient's glycemic&#xD;
      control. This information may be clinically useful to help physicians make better management&#xD;
      decisions, improve diabetes outcomes, avoid complications and reduce unnecessary spending.&#xD;
&#xD;
      This study is a pre-post, two-round randomized controlled study of a nationally&#xD;
      representative sample of primary care physicians randomly assigned to a control or&#xD;
      intervention arm. Enrolled participants will be asked to care for a sample of CPV® simulated&#xD;
      patients. The simulated patients are adults aged 18-75 who present with diabetes, different&#xD;
      levels of glycemic control and various co-morbidities. Participants randomized into an&#xD;
      intervention-arm will receive educational materials and 1,5-AG test results when caring for&#xD;
      their patients in round 2. Investigators will assess the participants' ability to identify&#xD;
      and address glycemic variability and hyperglycemia and evaluate whether physicians who have&#xD;
      access to GlycoMark take steps to optimize glycemic control and reduce unnecessary resource&#xD;
      utilization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Actual">February 24, 2019</completion_date>
  <primary_completion_date type="Actual">February 24, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is a pre-post, two-round, randomized controlled study of a nationally representative sample of primary care physicians, including internists and family physicians, randomly assigned to a control or intervention arm. Once eligibility is determined and providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background. They will then care for a total of 6 CPV® simulated patients over the two rounds (3 per round). The simulated patients are adults aged 18-75 who present with diabetes, different levels of glycemic control and various co-morbidities. The study design consists of two study arms, a control arm and an intervention-arm that receives educational materials and the 1,5-AG results.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis-Treatment</measure>
    <time_frame>3 months</time_frame>
    <description>Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Care</measure>
    <time_frame>3 months</time_frame>
    <description>Difference-in-differences regression analysis between the control and the intervention group's overall quality of care scores. In each CPV case, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each case.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Workup Costs</measure>
    <time_frame>3 months</time_frame>
    <description>Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>GlycoMark 1-5-AG</intervention_name>
    <description>Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical Performance and Value Vignettes</intervention_name>
    <description>Simulated diabetic patients cared for online</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>CPVs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A minimum of 2 years post residency but no more than 30 years in practice&#xD;
&#xD;
          -  Board-certified in internal medicine or family practice, primary care physicians&#xD;
&#xD;
          -  In a private solo or multi-group practice&#xD;
&#xD;
          -  Minimum threshold of patients (40+) currently seen weekly&#xD;
&#xD;
          -  A minimum of 15% of their panel under their care for diabetes&#xD;
&#xD;
          -  Have not used GlycoMark assay in the past&#xD;
&#xD;
          -  Informed, signed and voluntarily consented to be in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not board certified in their respective area of care&#xD;
&#xD;
          -  Academic-based practice&#xD;
&#xD;
          -  Have practiced as a board-certified physician for less than 2 or greater than 30 years&#xD;
&#xD;
          -  Have used the GlycoMark assay&#xD;
&#xD;
          -  Follow &lt;40 patients weekly&#xD;
&#xD;
          -  &lt; 15% of their patient panel under their care for diabetes&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Unable to access the internet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mary Tran, MS</last_name>
    <role>Study Director</role>
    <affiliation>QURE Healthcare</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John W Peabody, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>QURE Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>QURE Healthcare</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <results_first_submitted>September 14, 2020</results_first_submitted>
  <results_first_submitted_qc>September 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 8, 2020</results_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>March 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03765164/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control</title>
          <description>Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
        </group>
        <group group_id="P2">
          <title>Intervention</title>
          <description>Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.&#xD;
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Post-intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="72"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control</title>
          <description>Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.&#xD;
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</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="73"/>
            <count group_id="B2" value="72"/>
            <count group_id="B3" value="145"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;40</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40-55</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;55</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="50"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Practice locale (urban, suburban, or rural)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Urban</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Suburban</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Rural</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>U.S. Region Location of Practice</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="73"/>
                    <count group_id="B2" value="72"/>
                    <count group_id="B3" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Midwest</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Northeast</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>South</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>West</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Diagnosis-Treatment</title>
        <description>Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.&#xD;
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnosis-Treatment</title>
          <description>Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.</description>
          <units>CPV diagnosis-treatment percentage score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Round 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" spread="13.4"/>
                    <measurement group_id="O2" value="35.0" spread="15.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Round 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.1" spread="12.3"/>
                    <measurement group_id="O2" value="31.9" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Care</title>
        <description>Difference-in-differences regression analysis between the control and the intervention group's overall quality of care scores. In each CPV case, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each case.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.&#xD;
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Care</title>
          <description>Difference-in-differences regression analysis between the control and the intervention group's overall quality of care scores. In each CPV case, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each case.</description>
          <units>CPV overall percentage score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Round 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4" spread="11.1"/>
                    <measurement group_id="O2" value="52.1" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Round 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.9" spread="10.0"/>
                    <measurement group_id="O2" value="48.9" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Workup Costs</title>
        <description>Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.&#xD;
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
          </group>
        </group_list>
        <measure>
          <title>Workup Costs</title>
          <description>Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.</description>
          <units>US$</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Round 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" spread="156"/>
                    <measurement group_id="O2" value="37" spread="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Round 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54" spread="100"/>
                    <measurement group_id="O2" value="60" spread="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control</title>
          <description>Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</description>
        </group>
        <group group_id="E2">
          <title>Intervention</title>
          <description>Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.&#xD;
GlycoMark 1-5-AG: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients&#xD;
Clinical Performance and Value Vignettes: Simulated diabetic patients cared for online</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="73"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="73"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </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="73"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="72"/>
              </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>Director of Clinical Trials</name_or_title>
      <organization>QURE Healthcare</organization>
      <phone>415-321-3388</phone>
      <email>qureadmin@qurehealthcare.com</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/NCT03765164
org study id: Pro00024791
nct id: NCT03765164
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Glycemic excursions (temporary increases in blood glucose) are associated with health
      complications. Standard tests for diabetes (e.g. random blood sugar and HbA1c) do not test
      for these excursions despite their association with several health complications. GlycoMark's
      1,5-anhydroglucitol (1,5-AG) is a validated indicator of glucose excursions in addition to
      short-term (1-2 weeks) hyperglycemia.

      This study is a pre-post, two-round randomized controlled study of a nationally
      representative sample of primary care physicians. Investigators will assess whether physician
      participants are able to identify and address glycemic variability and hyperglycemia in their
      patients and, when given access to GlycoMark assay results, improve their patient management
      decisions by taking steps to optimize glycemic control, and reduce unnecessary resource
      utilization.
Nearly half of the adult population, 114 million Americans, are diagnosed with diabetes or
      pre-diabetes, making it one of the most important public and personal health problems.
      Diabetes is the 7th leading cause of death in America and a contributing factor in many more
      deaths and lost days of productivity. Its complications include vascular disease,
      cardiovascular disease, stroke and dementia. The cost of diabetes care and its complications
      lead to $176 billion in direct medical costs and $69 billion in reduced productivity. With an
      over 2-fold increase in diabetes prevalence in the past two decades and an estimated 1.5
      million new cases expected annually, it is clinically and economically critical for this
      condition to be managed appropriately.

      Diabetes treatment programs focus on controlling hyperglycemia (random glucose > 200 mg/dL)
      without causing hypoglycemia (glucose < 70 mg/dL). Glucose control is determined in a number
      of ways in current clinical practice. Immediate and fasting blood sugars are determined in
      routine chemistry tests. The standard measure of long-term diabetes control, HbA1c testing,
      provides a reliable reading of average blood glucose levels over a 2-3-month period. In
      patients with high HbA1c levels, HbA1c measurement guides management decisions and helps the
      clinician bring the long-term glucose levels under control in poorly controlled diabetic
      patients. Random blood sugars and HbA1c is limited in that they do not reflect glycemic
      control in intervals greater than the past few hours and 2-3 months. In particular, they do
      not provide an indication of frequent, temporary increases in blood glucose, termed glycemic
      excursions, which have been independently associated with several health complications. Since
      it takes months for HbA1c levels to stabilize, HbA1c levels are also not helpful for patients
      starting medication or changing drug therapy.

      1,5-anhydroglucitol (1,5-AG) is a molecule found in the blood and is a validated indicator of
      glucose excursions and short-term (1-2 weeks) hyperglycemia. In healthy patients without
      diabetes, or those with well-controlled diabetes, 1,5-AG is maintained at a steady state in
      the blood. However, during glycemic excursions, the molecule is actively purged from the body
      through the urine. Cleared by the FDA in 2003, the GlycoMark assay measures 1,5-AG levels in
      the blood. Low levels of 1,5-AG indicate the presence of potentially harmful glycemic
      excursion over the last 1 to 2 weeks, which may have been missed during random blood glucose
      testing and not sensitively detected by HbA1c.

      GlycoMark testing provides clinical details on peak glucose levels, daily spikes, and
      response to drugs, including short term effects, of hypoglycemic agents that are otherwise
      not available, giving physicians a more complete understanding of their patient's glycemic
      control. This information may be clinically useful to help physicians make better management
      decisions, improve diabetes outcomes, avoid complications and reduce unnecessary spending.

      This study is a pre-post, two-round randomized controlled study of a nationally
      representative sample of primary care physicians randomly assigned to a control or
      intervention arm. Enrolled participants will be asked to care for a sample of CPV® simulated
      patients. The simulated patients are adults aged 18-75 who present with diabetes, different
      levels of glycemic control and various co-morbidities. Participants randomized into an
      intervention-arm will receive educational materials and 1,5-AG test results when caring for
      their patients in round 2. Investigators will assess the participants' ability to identify
      and address glycemic variability and hyperglycemia and evaluate whether physicians who have
      access to GlycoMark take steps to optimize glycemic control and reduce unnecessary resource
      utilization.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a pre-post, two-round, randomized controlled study of a nationally representative sample of primary care physicians, including internists and family physicians, randomly assigned to a control or intervention arm. Once eligibility is determined and providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background. They will then care for a total of 6 CPV® simulated patients over the two rounds (3 per round). The simulated patients are adults aged 18-75 who present with diabetes, different levels of glycemic control and various co-morbidities. The study design consists of two study arms, a control arm and an intervention-arm that receives educational materials and the 1,5-AG results.
primary purpose: Other
masking: None (Open Label)
measure: Diagnosis-Treatment
time frame: 3 months
description: Difference-in-differences regression analysis between the control and the intervention group's identification and treatment of hyperglycemia, as measured by the participants diagnostic and treatment CPV case domain scores. In each domain of a CPV (history, physical exam, workup, diagnosis and treatment), participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each domain.
measure: Quality of Care
time frame: 3 months
description: Difference-in-differences regression analysis between the control and the intervention group's overall quality of care scores. In each CPV case, participants' care recommendations are evaluated against evidence-based care scoring criteria which can sum to a high potential score of up to 100% in each case.
measure: Workup Costs
time frame: 3 months
description: Difference-in-differences regression analysis between between the control and the intervention group in the average cost of diagnostic tests ordered.
arm group label: Control
arm group type: Active Comparator
description: Control participants will care for the same set of CPV patients as the intervention arm, but will not have knowledge of or access to GlycoMark 1,5-AG test results. Investigators will compare control participants' clinical recommendations to those in the intervention arm.
arm group label: Intervention
arm group type: Experimental
description: Intervention participants will care for the same set of CPV patients as the control arm, but will be educated on and given access to GlycoMark 1,5-AG test results. Investigators will compare intervention participants' clinical recommendations to those in the control arm.
intervention type: Diagnostic Test
intervention name: GlycoMark 1-5-AG
description: Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
arm group label: Intervention
intervention type: Other
intervention name: Clinical Performance and Value Vignettes
description: Simulated diabetic patients cared for online
arm group label: Control
arm group label: Intervention
other name: CPVs
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mary Tran, MS
role: Study Director
affiliation: QURE Healthcare
last name: John W Peabody, MD
role: Principal Investigator
affiliation: QURE Healthcare
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 