<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/NCT04428645</url>
  </required_header>
  <id_info>
    <org_study_id>19950</org_study_id>
    <nct_id>NCT04428645</nct_id>
  </id_info>
  <brief_title>Assessment of a Decision Support Tool in Participants With Type 1 Diabetes</brief_title>
  <official_title>Assessment of a Decision Support Tool in Participants With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia&#xD;
      which can lead to severe acute and chronic complications. The burden and complexity of&#xD;
      managing T1D results in the majority of people not reaching adequate glycemic control. Our&#xD;
      team has developed a smartphone based application, DailyDose, that combines continuous&#xD;
      glucose monitoring data and insulin data to provide decision support for subjects with type 1&#xD;
      diabetes taking multiple daily injections (MDI). DailyDose provides on-demand, real-time&#xD;
      dosing recommendations for insulin doses prior to meals and to correct hyperglycemia.&#xD;
      DailyDose analyzes glucose patterns and provides weekly recommendations to the patient on&#xD;
      insulin settings including carbohydrate ratios and correction factors. As needed, DailyDose&#xD;
      will make weekly recommendations to change basal insulin. For subject safety, study&#xD;
      investigators will set constraints on settings for short and long acting insulin during the&#xD;
      onboarding process. DailyDose will not be able to recommend insulin dose changes above or&#xD;
      below the set safety thresholds. DailyDose also provides recommendations on carbohydrate&#xD;
      intake for exercise and includes hypoglycemia and hyperglycemia alarms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be on study for 10 weeks. Subjects will begin the study with a training visit&#xD;
      on the Dexcom G6 CGM system and the InPen and Clipsulin smart insulin pens. Subjects will use&#xD;
      these devices for the next 14 days at home. Subjects will return to OHSU at the end of the 14&#xD;
      days for a training on using the DailyDose system. Subjects will then return home to use the&#xD;
      DailyDose system for 8 weeks. Sensor glucose, exercise, insulin and meal data will be&#xD;
      collected during the DailyDose portion of the study in order to produce recommendations for&#xD;
      insulin dosing. Subjects will receive up to 4 recommendations every 7 days. Subjects will&#xD;
      also receive recommendations for exercise based on the PEAK exercise guidelines.&#xD;
&#xD;
      Subjects will wear the Dexcom G6 and an Apple Watch physical activity monitor for the entire&#xD;
      study. Insulin data will be collected using the InPen for aspart insulin and Clipsulin for&#xD;
      the long acting insulin. Subjects will complete a 30 minute aerobic exercise video at home&#xD;
      once per week. Subjects will also be asked to complete two additional exercise sessions on&#xD;
      their own at home, one aerobic session and the other whatever type of exercise they would&#xD;
      normally do (aerobic, resistance etc.). Subjects will use the bolus calculator within the&#xD;
      DailyDose app. Subjects will be instructed to test capillary blood glucose (CBG) after&#xD;
      exercise, for symptoms of hypoglycemia or hypoglycemia alerts and again 15 minutes after&#xD;
      rescue carbohydrate treatment until CBG &gt;70 mg/dl.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">November 15, 2021</completion_date>
  <primary_completion_date type="Actual">November 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl</measure>
    <time_frame>Weeks 1-2 and 9-10</time_frame>
    <description>Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Sensed Glucose</measure>
    <time_frame>Weeks 1-2 and 9-10</time_frame>
    <description>Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in the Percent of Time With Sensed Glucose &lt;70 mg/dl</measure>
    <time_frame>Weeks 1-2 and 9-10</time_frame>
    <description>Mean change in the percent of time with sensed glucose &lt; 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in the Percent of Time With Sensed Glucose &lt;54 mg/dl</measure>
    <time_frame>Weeks 1-2 and 9-10</time_frame>
    <description>Mean change in the percent of time with sensed glucose &lt; 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in the Percent of Time With Sensed Glucose &gt;180 mg/dl</measure>
    <time_frame>Weeks 1-2 and 9-10</time_frame>
    <description>Mean change in the percent of time with sensed glucose &gt;180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in the Percent of Time With Sensed Glucose &gt;250 mg/dl</measure>
    <time_frame>Weeks 1-2 and 9-10</time_frame>
    <description>Mean change in the percent of time with sensed glucose &gt;250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data.</measure>
    <time_frame>Weeks 1-2 and 9-10</time_frame>
    <description>Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>DailyDose Decision Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will use DailyDose decision support for 8 weeks at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DailyDose Decision Support</intervention_name>
    <description>DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
    <arm_group_label>DailyDose Decision Support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of type 1 diabetes mellitus for at least 1 year.&#xD;
&#xD;
          -  Male or female subjects 18 to 60 years of age.&#xD;
&#xD;
          -  Physically willing and able to perform 30 min of exercise (as determined by the&#xD;
             investigator after reviewing the subject's activity level).&#xD;
&#xD;
          -  Use of multiple daily insulin injections (MDI) for at least 4 weeks at time of&#xD;
             screening visit.&#xD;
&#xD;
          -  A1C 7.0-10.0% at the time of screening.&#xD;
&#xD;
          -  Willingness to follow all study procedures, including attending all clinic visits.&#xD;
&#xD;
          -  Willingness to sign informed consent and HIPAA documents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female of childbearing potential who is pregnant or intending to become pregnant or&#xD;
             breast-feeding, or is not using adequate contraceptive methods. Acceptable&#xD;
             contraception includes birth control pill / patch / vaginal ring, Depo-Provera,&#xD;
             Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide&#xD;
             and the man uses a condom), or abstinence.&#xD;
&#xD;
          -  Any cardiovascular disease, defined as a clinically significant EKG abnormality at the&#xD;
             time of screening or any history of: stroke, heart failure, myocardial infarction,&#xD;
             angina pectoris, or coronary arterial bypass graft or angioplasty. Diagnosis of 2nd or&#xD;
             3rd degree heart block or any non-physiological arrhythmia judged by the investigator&#xD;
             to be exclusionary.&#xD;
&#xD;
          -  Renal insufficiency (GFR &lt; 60 ml/min, using the MDRD equation as reported by the OHSU&#xD;
             laboratory).&#xD;
&#xD;
          -  Liver failure, cirrhosis, or any other liver disease that compromises liver function&#xD;
             as determined by the investigator.&#xD;
&#xD;
          -  History of severe hypoglycemia during the past 6 months prior to screening visit or&#xD;
             hypoglycemia unawareness as judged by the investigator. Subjects will complete a&#xD;
             hypoglycemia awareness questionnaire. Subjects will be excluded for four or more R&#xD;
             responses.&#xD;
&#xD;
          -  Any active infection.&#xD;
&#xD;
          -  Known or suspected abuse of alcohol, narcotics, or illicit drugs.&#xD;
&#xD;
          -  Seizure disorder.&#xD;
&#xD;
          -  Active foot ulceration.&#xD;
&#xD;
          -  Peripheral arterial disease.&#xD;
&#xD;
          -  Major surgical operation within 30 days prior to screening.&#xD;
&#xD;
          -  Use of an investigational drug within 30 days prior to screening.&#xD;
&#xD;
          -  Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine,&#xD;
             sirolimus, or tacrolimus).&#xD;
&#xD;
          -  Allergy to aspart insulin.&#xD;
&#xD;
          -  Current administration of oral or parenteral corticosteroids.&#xD;
&#xD;
          -  Any life threatening disease, including malignant neoplasms and medical history of&#xD;
             malignant neoplasms within the past 5 years prior to screening (except basal and&#xD;
             squamous cell skin cancer).&#xD;
&#xD;
          -  Current use of any medication intended to lower glucose other than insulin (ex. use of&#xD;
             liraglutide).&#xD;
&#xD;
          -  Vision impairment which in the opinion of the investigator would preclude the use of&#xD;
             the smart phone application.&#xD;
&#xD;
          -  A positive response to any of the questions from the Physical Activity Readiness&#xD;
             Questionnaire with one exception: subject will not be excluded if he/she takes a&#xD;
             single blood pressure medication that doesn't impact heart rate and blood pressure is&#xD;
             controlled on the medication (blood pressure is less than 140/90 mmHg).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Jacobs, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jessica Castle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>April 20, 2022</results_first_submitted>
  <results_first_submitted_qc>May 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 13, 2022</results_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Jessica Castle</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04428645/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DailyDose Decision Support</title>
          <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Run in Visit Training (2 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>First at Home Period (~2 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>DailyDose Training Visit (2 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second at Home Period (8 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Study Close-out Visit (30 Minutes)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DailyDose Decision Support</title>
          <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.8" spread="9.8"/>
                  </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="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl</title>
        <description>Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
        <time_frame>Weeks 1-2 and 9-10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DailyDose Decision Support</title>
            <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl</title>
          <description>Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Sensed Glucose</title>
        <description>Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
        <time_frame>Weeks 1-2 and 9-10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DailyDose Decision Support</title>
            <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Sensed Glucose</title>
          <description>Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in the Percent of Time With Sensed Glucose &lt;70 mg/dl</title>
        <description>Mean change in the percent of time with sensed glucose &lt; 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
        <time_frame>Weeks 1-2 and 9-10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DailyDose Decision Support</title>
            <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in the Percent of Time With Sensed Glucose &lt;70 mg/dl</title>
          <description>Mean change in the percent of time with sensed glucose &lt; 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in the Percent of Time With Sensed Glucose &lt;54 mg/dl</title>
        <description>Mean change in the percent of time with sensed glucose &lt; 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
        <time_frame>Weeks 1-2 and 9-10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DailyDose Decision Support</title>
            <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in the Percent of Time With Sensed Glucose &lt;54 mg/dl</title>
          <description>Mean change in the percent of time with sensed glucose &lt; 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0006" spread="0.472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in the Percent of Time With Sensed Glucose &gt;180 mg/dl</title>
        <description>Mean change in the percent of time with sensed glucose &gt;180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
        <time_frame>Weeks 1-2 and 9-10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DailyDose Decision Support</title>
            <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in the Percent of Time With Sensed Glucose &gt;180 mg/dl</title>
          <description>Mean change in the percent of time with sensed glucose &gt;180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in the Percent of Time With Sensed Glucose &gt;250 mg/dl</title>
        <description>Mean change in the percent of time with sensed glucose &gt;250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
        <time_frame>Weeks 1-2 and 9-10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DailyDose Decision Support</title>
            <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in the Percent of Time With Sensed Glucose &gt;250 mg/dl</title>
          <description>Mean change in the percent of time with sensed glucose &gt;250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data.</title>
        <description>Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
        <time_frame>Weeks 1-2 and 9-10</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DailyDose Decision Support</title>
            <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data.</title>
          <description>Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.</description>
          <units>percent of CV</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks</time_frame>
      <desc>All participants that started a visit are included in the adverse events. All subjects completed all visits except one. That subject only completed two of the three visits.</desc>
      <group_list>
        <group group_id="E1">
          <title>DailyDose Decision Support</title>
          <description>Subjects will use DailyDose decision support for 8 weeks at home.&#xD;
DailyDose Decision Support: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.</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="25"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="2" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>upper respiratory infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>vaginal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
              <event>
                <sub_title>strep throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="25"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jessica Castle</name_or_title>
      <organization>Oregon Health and Science University</organization>
      <phone>503-494-7072</phone>
      <email>castleje@ohsu.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/NCT04428645
org study id: 19950
nct id: NCT04428645
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Type 1 diabetes (T1D) is a complex disease with a high risk of both hyper- and hypoglycemia
      which can lead to severe acute and chronic complications. The burden and complexity of
      managing T1D results in the majority of people not reaching adequate glycemic control. Our
      team has developed a smartphone based application, DailyDose, that combines continuous
      glucose monitoring data and insulin data to provide decision support for subjects with type 1
      diabetes taking multiple daily injections (MDI). DailyDose provides on-demand, real-time
      dosing recommendations for insulin doses prior to meals and to correct hyperglycemia.
      DailyDose analyzes glucose patterns and provides weekly recommendations to the patient on
      insulin settings including carbohydrate ratios and correction factors. As needed, DailyDose
      will make weekly recommendations to change basal insulin. For subject safety, study
      investigators will set constraints on settings for short and long acting insulin during the
      onboarding process. DailyDose will not be able to recommend insulin dose changes above or
      below the set safety thresholds. DailyDose also provides recommendations on carbohydrate
      intake for exercise and includes hypoglycemia and hyperglycemia alarms.
Subjects will be on study for 10 weeks. Subjects will begin the study with a training visit
      on the Dexcom G6 CGM system and the InPen and Clipsulin smart insulin pens. Subjects will use
      these devices for the next 14 days at home. Subjects will return to OHSU at the end of the 14
      days for a training on using the DailyDose system. Subjects will then return home to use the
      DailyDose system for 8 weeks. Sensor glucose, exercise, insulin and meal data will be
      collected during the DailyDose portion of the study in order to produce recommendations for
      insulin dosing. Subjects will receive up to 4 recommendations every 7 days. Subjects will
      also receive recommendations for exercise based on the PEAK exercise guidelines.

      Subjects will wear the Dexcom G6 and an Apple Watch physical activity monitor for the entire
      study. Insulin data will be collected using the InPen for aspart insulin and Clipsulin for
      the long acting insulin. Subjects will complete a 30 minute aerobic exercise video at home
      once per week. Subjects will also be asked to complete two additional exercise sessions on
      their own at home, one aerobic session and the other whatever type of exercise they would
      normally do (aerobic, resistance etc.). Subjects will use the bolus calculator within the
      DailyDose app. Subjects will be instructed to test capillary blood glucose (CBG) after
      exercise, for symptoms of hypoglycemia or hypoglycemia alerts and again 15 minutes after
      rescue carbohydrate treatment until CBG >70 mg/dl.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change in the Percent of Time With Sensed Glucose Between 70 - 180 mg/dl
time frame: Weeks 1-2 and 9-10
description: Mean change in the percent of time with sensed glucose between 70 - 180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
measure: Mean Change in Sensed Glucose
time frame: Weeks 1-2 and 9-10
description: Mean change in sensed glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
measure: Mean Change in the Percent of Time With Sensed Glucose <70 mg/dl
time frame: Weeks 1-2 and 9-10
description: Mean change in the percent of time with sensed glucose < 70 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
measure: Mean Change in the Percent of Time With Sensed Glucose <54 mg/dl
time frame: Weeks 1-2 and 9-10
description: Mean change in the percent of time with sensed glucose < 54 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
measure: Mean Change in the Percent of Time With Sensed Glucose >180 mg/dl
time frame: Weeks 1-2 and 9-10
description: Mean change in the percent of time with sensed glucose >180 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
measure: Mean Change in the Percent of Time With Sensed Glucose >250 mg/dl
time frame: Weeks 1-2 and 9-10
description: Mean change in the percent of time with sensed glucose >250 mg/dl based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
measure: Change in Coefficient of Variation of Sensor Glucose Based on the Dexcom G6 CGM Data.
time frame: Weeks 1-2 and 9-10
description: Change in coefficient of variation of sensor glucose based on the Dexcom G6 CGM data between weeks 1-2 and 9-10.
arm group label: DailyDose Decision Support
arm group type: Experimental
description: Subjects will use DailyDose decision support for 8 weeks at home.
intervention type: Device
intervention name: DailyDose Decision Support
description: DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
arm group label: DailyDose Decision Support
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Peter Jacobs, PhD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: Jessica Castle, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Jessica Castle
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 