<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/NCT03260868</url>
  </required_header>
  <id_info>
    <org_study_id>MSC15146</org_study_id>
    <secondary_id>U1111-1188-5647</secondary_id>
    <nct_id>NCT03260868</nct_id>
  </id_info>
  <brief_title>Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)</brief_title>
  <official_title>Evaluation of Virtual Versus Traditional Study Conduct in a 6-month, Multicenter, Randomized, Open-label, Two-parallel Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To evaluate the effect of virtual approach via novel technologies versus traditional study&#xD;
      conduct on glycemic control in terms of glycated hemoglobin (HbA1c).&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
      To evaluate the appropriate utilization of virtual approach via novel technologies during the&#xD;
      study and to assess the effect of the virtual versus traditional study conduct on multiple&#xD;
      outcomes in terms of study methodology and diabetes management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study had a maximum study duration of 29 weeks, which consisted of a 3-week screening&#xD;
      period (including a possible 1-week delay in first investigational medicinal product [IMP]&#xD;
      administration after randomization in virtual group due to shipment of IMP and the virtual&#xD;
      devices), a 24-week treatment period, and 1-week post-treatment safety follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to &quot;prolonged low participant recruitment&quot;&#xD;
  </why_stopped>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">November 22, 2018</completion_date>
  <primary_completion_date type="Actual">November 22, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Change in HbA1c was calculated by subtracting baseline value from Week 24 value.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glycated Hemoglobin A1c to Week 16</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>Change in HbA1c was calculated by subtracting baseline value from Week 16 value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24</measure>
    <time_frame>Baseline, Week 16, Week 24</time_frame>
    <description>Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource Use Questionnaire (RUQ) Scores</measure>
    <time_frame>During 24 weeks treatment period</time_frame>
    <description>Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia Fear Survey-II (HFS-II) Scores</measure>
    <time_frame>At Week 24</time_frame>
    <description>Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) &quot;Never&quot; to 4 = &quot;Always&quot;. Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Distress Scale (DDS) Scores</measure>
    <time_frame>Week 0, Week 24</time_frame>
    <description>Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point</measure>
    <time_frame>Baseline, Week 16, Week 24</time_frame>
    <description>7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Daily Insulin Doses</measure>
    <time_frame>During 24 weeks treatment period</time_frame>
    <description>Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator</measure>
    <time_frame>During 24 weeks treatment period</time_frame>
    <description>An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24</measure>
    <time_frame>At Week 24</time_frame>
    <description>An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period</measure>
    <time_frame>During 24 weeks treatment period</time_frame>
    <description>Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;=3.9 mmol/L (70 mg/dL) or &lt;3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration &lt;=3.9 mmol/L (70 mg/dL) or &lt;3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration &gt;3.9 mmol/L (70 mg/dL).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Virtual</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin glargine, 300 units per milliliter (U/mL)</intervention_name>
    <description>Self-administered subcutaneous injection using prefilled pen once daily for 24 weeks. Dose titration to achieve fasting self-monitoring of plasma glucose (SMPG) level between 80 and 130 milligram per deciliter (mg/dL).</description>
    <arm_group_label>Traditional</arm_group_label>
    <arm_group_label>Virtual</arm_group_label>
    <other_name>Toujeo ®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)</intervention_name>
    <description>Subcutaneous injection.</description>
    <arm_group_label>Traditional</arm_group_label>
    <arm_group_label>Virtual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Participants with Type 1 diabetes mellitus (T1DM) diagnosed at least one year before&#xD;
             the screening visit.&#xD;
&#xD;
          -  Participants who were treated with multi-dose insulin using insulin glargine 100 U/mL&#xD;
             (eg, Lantus or Basaglar) as basal insulin and rapid acting insulin analogues as bolus&#xD;
             insulin.&#xD;
&#xD;
          -  Participants with access to or experience with mobile technology (eg, tablet or smart&#xD;
             phone).&#xD;
&#xD;
          -  eSign the consent on the study web portal.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Age less than (&lt;) 18 years at screening (Visit 1 - Step 1).&#xD;
&#xD;
          -  Type 2 diabetes mellitus.&#xD;
&#xD;
          -  HbA1c &lt;5.4 percent (%) or greater than or equal to (&gt;=) 9.0% measured by the central&#xD;
             lab at Visit 1.&#xD;
&#xD;
          -  Participants who received &lt;6 months treatment with any basal plus (+) meal-time&#xD;
             insulin.&#xD;
&#xD;
          -  Use of any basal insulins other than insulin glargine 100 U/mL (eg, Lantus or&#xD;
             Basaglar) within 3 months before screening.&#xD;
&#xD;
          -  Use of an insulin pump within 6 months before screening.&#xD;
&#xD;
          -  Use of meal-time insulin other than rapid-acting insulin analogs (Humalog, Novolog, or&#xD;
             Apidra), eg, human regular insulin, within 30 days before screening.&#xD;
&#xD;
          -  Hemoglobinopathy resulting in undetectable HbA1c by the central laboratory, or&#xD;
             hemolytic anemia requiring transfusion of blood or plasma products within 3 months&#xD;
             before screening.&#xD;
&#xD;
          -  Participants experienced with any severe hypoglycemic episode resulting in seizure,&#xD;
             unconsciousness, or coma, and/or leading to hospitalization during the past 6 months&#xD;
             before screening.&#xD;
&#xD;
          -  Participants with insufficient smart phone skills or unwilling to properly use the&#xD;
             virtual tools deemed by the investigator based on the observation and experiences over&#xD;
             the digital screening procedure-Mental disorders or any neurologic disorder that would&#xD;
             affect participant's ability to meet the study requirements, or participants deemed&#xD;
             unlikely to safely manage insulin dosage by the investigator.&#xD;
&#xD;
          -  Known hypersensitivity/intolerance to insulin glargine, rapid-acting insulin analogs&#xD;
             or any of their excipients.&#xD;
&#xD;
          -  Pregnant or breast-feeding women, or women who intend to become pregnant during the&#xD;
             study period.&#xD;
&#xD;
        The above information was not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 8400002</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400004</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 8400003</name>
      <address>
        <city>Bridgeport</city>
        <state>West Virginia</state>
        <zip>26330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240001</name>
      <address>
        <city>Barrie</city>
        <zip>L4M 7G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240003</name>
      <address>
        <city>Oakville</city>
        <zip>L6M 1M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1240002</name>
      <address>
        <city>Thornhill</city>
        <zip>L4J 8L7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <results_first_submitted>November 21, 2019</results_first_submitted>
  <results_first_submitted_qc>December 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 7, 2020</results_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Insulin Glargine</mesh_term>
    <mesh_term>Insulin Lispro</mesh_term>
    <mesh_term>Insulin Aspart</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03260868/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03260868/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled in the study at 6 sites in Canada and United States between 19 September 2017 and 02 October 2018.</recruitment_details>
      <pre_assignment_details>A total of 15 participants were randomized in study. Randomization was stratified by glycated hemoglobin (HbA1c) (less than [&lt;] 7.6 percent [%] and greater than or equal to [&gt;=] 7.6%) value at screening visit. Assignment in arms was done using interactive response technology (IRT) in 1:1 ratio to either virtual or traditional approach group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Virtual</title>
          <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
        </group>
        <group group_id="P2">
          <title>Traditional</title>
          <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Poor Compliance to Protocol</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified above</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on randomized population which included any participant who was allocated to a study conduct approach group regardless of whether the study conduct approach group was followed.</population>
      <group_list>
        <group group_id="B1">
          <title>Virtual</title>
          <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
        </group>
        <group group_id="B2">
          <title>Traditional</title>
          <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="15"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.1" spread="5.6"/>
                    <measurement group_id="B2" value="45.6" spread="14.3"/>
                    <measurement group_id="B3" value="49.6" spread="10.9"/>
                  </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="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <population>Number analyzed signifies participants evaluable for this baseline measure.</population>
          <units>kilogram per meter square (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.2" spread="18.4"/>
                    <measurement group_id="B2" value="30.9" spread="4.1"/>
                    <measurement group_id="B3" value="34.8" spread="13.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Type 1 Diabetes</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.4" spread="11.5"/>
                    <measurement group_id="B2" value="19.3" spread="12.7"/>
                    <measurement group_id="B3" value="26.3" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24</title>
        <description>Change in HbA1c was calculated by subtracting baseline value from Week 24 value.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Analysis was performed on intent to treat (ITT) population which included all randomized participants, irrespective of the trial approach group actually being used, analyzed according to the approach group allocated by randomization. Here, &quot;overall number of participants analyzed&quot; signifies participants with available data for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24</title>
          <description>Change in HbA1c was calculated by subtracting baseline value from Week 24 value.</description>
          <population>Analysis was performed on intent to treat (ITT) population which included all randomized participants, irrespective of the trial approach group actually being used, analyzed according to the approach group allocated by randomization. Here, &quot;overall number of participants analyzed&quot; signifies participants with available data for the outcome measure.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.76"/>
                    <measurement group_id="O2" value="0.33" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Glycated Hemoglobin A1c to Week 16</title>
        <description>Change in HbA1c was calculated by subtracting baseline value from Week 16 value.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>Analysis was performed on ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glycated Hemoglobin A1c to Week 16</title>
          <description>Change in HbA1c was calculated by subtracting baseline value from Week 16 value.</description>
          <population>Analysis was performed on ITT population. Here, 'overall number of participants analyzed' signifies participants with available data for the outcome measure.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.52"/>
                    <measurement group_id="O2" value="0.45" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24</title>
        <description>Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.</description>
        <time_frame>Baseline, Week 16, Week 24</time_frame>
        <population>Analysis was performed on ITT population. Here, &quot;number analyzed&quot; signifies participants with available data for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24</title>
          <description>Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.</description>
          <population>Analysis was performed on ITT population. Here, &quot;number analyzed&quot; signifies participants with available data for each time point.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.660" spread="2.387"/>
                    <measurement group_id="O2" value="-0.200" spread="4.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.625" spread="3.406"/>
                    <measurement group_id="O2" value="2.900" spread="1.758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24</title>
        <description>Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.</description>
        <time_frame>At Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24</title>
          <description>Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24</title>
        <description>Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24</title>
          <description>Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24</title>
        <description>Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24</title>
          <description>Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24</title>
        <description>Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24</title>
          <description>Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Resource Use Questionnaire (RUQ) Scores</title>
        <description>Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.</description>
        <time_frame>During 24 weeks treatment period</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Resource Use Questionnaire (RUQ) Scores</title>
          <description>Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24</title>
        <description>The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24</title>
          <description>The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24</title>
        <description>DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24</title>
          <description>DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hypoglycemia Fear Survey-II (HFS-II) Scores</title>
        <description>Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) &quot;Never&quot; to 4 = &quot;Always&quot;. Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry.</description>
        <time_frame>At Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Hypoglycemia Fear Survey-II (HFS-II) Scores</title>
          <description>Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) &quot;Never&quot; to 4 = &quot;Always&quot;. Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Diabetes Distress Scale (DDS) Scores</title>
        <description>Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.</description>
        <time_frame>Week 0, Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Diabetes Distress Scale (DDS) Scores</title>
          <description>Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point</title>
        <description>7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.</description>
        <time_frame>Baseline, Week 16, Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point</title>
          <description>7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Daily Insulin Doses</title>
        <description>Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.</description>
        <time_frame>During 24 weeks treatment period</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Daily Insulin Doses</title>
          <description>Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator</title>
        <description>An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)</description>
        <time_frame>During 24 weeks treatment period</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator</title>
          <description>An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24</title>
        <description>An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.</description>
        <time_frame>At Week 24</time_frame>
        <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24</title>
          <description>An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.</description>
          <population>Data were not collected due to data transfer issues therefore analysis was not performed for this outcome.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period</title>
        <description>Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;=3.9 mmol/L (70 mg/dL) or &lt;3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration &lt;=3.9 mmol/L (70 mg/dL) or &lt;3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration &gt;3.9 mmol/L (70 mg/dL).</description>
        <time_frame>During 24 weeks treatment period</time_frame>
        <population>Analysis was done on safety population which included all randomized participants who did actually receive at least one dose of investigational medicinal product (IMP), regardless of the amount of IMP administered.</population>
        <group_list>
          <group group_id="O1">
            <title>Virtual</title>
            <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
          </group>
          <group group_id="O2">
            <title>Traditional</title>
            <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period</title>
          <description>Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of &lt;=3.9 mmol/L (70 mg/dL) or &lt;3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration &lt;=3.9 mmol/L (70 mg/dL) or &lt;3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration &gt;3.9 mmol/L (70 mg/dL).</description>
          <population>Analysis was done on safety population which included all randomized participants who did actually receive at least one dose of investigational medicinal product (IMP), regardless of the amount of IMP administered.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycemia: &lt;=3.9 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Documented symptomatic hypoglycemia: &lt;3.0 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Probable symptomatic hypoglycemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic hypoglycemia &lt;=3.9 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asymptomatic hypoglycemia &lt;3.0 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pseudo-hypoglycemia &gt;3.9 mmol/L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All Adverse Events (AEs) were collected from time of first dose of study drug up to 25 weeks regardless of seriousness or relationship to investigational product.</time_frame>
      <desc>Reported AEs are treatment emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration to the last study drug administration + 1 week). Analysis was performed on safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Virtual</title>
          <description>Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.</description>
        </group>
        <group group_id="E2">
          <title>Traditional</title>
          <description>Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Obstructive Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Escherichia Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Loss Of Consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis Viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol Poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Head Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral Disc Degeneration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vertebral Osteophyte</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Intermittent Claudication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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>The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Planned analysis could not be performed due to early study termination.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi</organization>
      <phone>800-633-1610 ext 1#</phone>
      <email>Contact-US@sanofi.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/NCT03260868
org study id: MSC15146
secondary id: U1111-1188-5647
nct id: NCT03260868
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Primary Objective:

      To evaluate the effect of virtual approach via novel technologies versus traditional study
      conduct on glycemic control in terms of glycated hemoglobin (HbA1c).

      Secondary Objective:

      To evaluate the appropriate utilization of virtual approach via novel technologies during the
      study and to assess the effect of the virtual versus traditional study conduct on multiple
      outcomes in terms of study methodology and diabetes management.
The study had a maximum study duration of 29 weeks, which consisted of a 3-week screening
      period (including a possible 1-week delay in first investigational medicinal product [IMP]
      administration after randomization in virtual group due to shipment of IMP and the virtual
      devices), a 24-week treatment period, and 1-week post-treatment safety follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24
time frame: Baseline, Week 24
description: Change in HbA1c was calculated by subtracting baseline value from Week 24 value.
measure: Change From Baseline in Glycated Hemoglobin A1c to Week 16
time frame: Baseline, Week 16
description: Change in HbA1c was calculated by subtracting baseline value from Week 16 value.
measure: Change From Baseline in Fasting Plasma Glucose (FPG) to Week 16 and Week 24
time frame: Baseline, Week 16, Week 24
description: Change in FPG was calculated by subtracting baseline value from Week 16 value (for change at Week 16) and Week 24 (for change at Week 24) value.
measure: Participant Satisfaction With Trial Experience: Was It Worth It (WIWI) Questionnaire Response at Week 24
time frame: At Week 24
description: Participant satisfaction with trial experience was measured using the WIWI questionnaire. The WIWI had 5 questions, 3 questions with level categorical response (Yes, No, and Unsure) scale, 1 question with 3 possible answers as: Better than I expected/The same as I expected/Worse than I expected, and 1 question with 3 possible answers: It improved/Stayed the same/Become worse.
measure: Change From Baseline in Work Productivity and Impairment-Study Participation (WPAI-SP) Scores to Week 24
time frame: Baseline, Week 24
description: Effect of trial on a participants' ability to work and perform regular activities were measured using WPAI-SP. WPAI-SP had 6 items scored separately, where higher score indicated greater impairment and less productivity.
measure: Change From Baseline in Overall Study Experience-Participation (OSEP) Part-1 Questionnaire Score to Week 24
time frame: Baseline, Week 24
description: Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-1 contained 4 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher perception of diabetes control.
measure: Change From Baseline in Overall Study Experience-Participation Part-2 Questionnaire Score to Week 24
time frame: Baseline, Week 24
description: Participant burden with trial participation was measured using the OSEP Questionnaire, administered electronically. OSEP Part-2 contained 9 items to examine perceptions of study participation. Each item was measured on an 11 point scale ranged from 0 (completely disagree) to 10 (completely agree), where higher score indicated higher burden with trial participation.
measure: Resource Use Questionnaire (RUQ) Scores
time frame: During 24 weeks treatment period
description: Healthcare resource use was measured using the RUQ which asked participants to report the resources used (time and expenses) during the previous 4 weeks in terms of visits to healthcare professionals.
measure: Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) to Week 24
time frame: Baseline, Week 24
description: The DTSQs was a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consisted of 8 items that were answered on a Likert scale from 0 (no satisfaction) to 6 (high satisfaction with treatment). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment).
measure: Change From Baseline in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) Score to Week 24
time frame: Baseline, Week 24
description: DTSQc measured the relative change in treatment satisfaction from previous therapy. It consists of 8 items that were answered on a 6 point scale ranges from 3 (much less satisfied) to -3 (much more satisfied). Total treatment satisfaction score was the sum of items 1, 4-8 scores and ranged from -18 (much less satisfied) to +18 (much more satisfied), higher score indicated more satisfaction.
measure: Hypoglycemia Fear Survey-II (HFS-II) Scores
time frame: At Week 24
description: Fear of hypoglycemia was measured with HFS-II at Week 24. The HFS-II comprises 33 items: 15 items explore behaviors that participants were engaged in to avoid low blood sugar and its negative consequences and 18 items related to concern/worry that participants had about their hypoglycemia. Responses to each item were made on a 5-point Likert scale ranges from 0 equal (=) "Never" to 4 = "Always". Total HFS mean score was determined by computing the mean of all 33 items and the score ranged from 0 to 4, where higher score indicated more fear/worry.
measure: Diabetes Distress Scale (DDS) Scores
time frame: Week 0, Week 24
description: Diabetes-related distress was measured using DDS. The DDS contained 17 items related to potential problem areas that people with diabetes may experience. Participants were asked to consider the degree to which each of the items might have distressed or bothered them during the past month, and respond for each item on a 7 point scale ranges from 1 (not a problem) to 6 (a very serious problem), higher score indicated more diabetes related distress.
measure: Change From Baseline in 7-Point Self-Monitoring of Plasma Glucose (SMPG) Profiles at Week 16 and Week 24 Per Time Point
time frame: Baseline, Week 16, Week 24
description: 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 16, and Week 24): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit.
measure: Average Daily Insulin Doses
time frame: During 24 weeks treatment period
description: Average daily insulin doses included basal insulin doses, mealtime insulin doses, and total insulin doses.
measure: Overall Study Experience-Sites (OSES) Questionnaire Part-1: Hours Spent by Investigator
time frame: During 24 weeks treatment period
description: An OSES questionnaire was completed by Site Investigator and had 2 parts. The OSES Part-1 contained quantitative 1 item (question) to examine resource requirements which was: Approximately how much time did you spend with this participant (in person or via phone) during this scheduled visit/communication? (hours)
measure: Overall Study Experience-Sites Questionnaire Part-2 Scores for Site-Perceived Participant Relationship and Satisfaction at Week 24
time frame: At Week 24
description: An OSES questionnaire was completed by site investigator and had two parts. OSES Part-2 contains 2 items to examine investigator-participant relationship and satisfaction with care. Both items were assessed on a scale of 0 [completely disagree] to 10 [completely agree]), where highest score indicated a good relationship and satisfaction with care.
measure: Number of Participants With At Least One Hypoglycemic Events (Any, Severe Documented Symptomatic, Probable Symptomatic, Asymptomatic, Pseudo-hypoglycemia: Any Time of the Day) During 24 Week Treatment Period
time frame: During 24 weeks treatment period
description: Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=3.9 mmol/L (70 mg/dL) or <3.0 mmol/L (54 mg/dL). Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration. Pseudo-hypoglycemia: an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >3.9 mmol/L (70 mg/dL).
arm group label: Virtual
arm group type: Experimental
description: Participants included in this virtual trial approach group did not visit the study sites during the study course. All study assessments, including vital signs, weight, laboratory variables, etc., were completed via the Bluetooth devices that instantly transfer the digital data.
arm group label: Traditional
arm group type: Active Comparator
description: Participants included in this traditional trial approach group visited the study site, followed the study visit schedules for all study assessments that was performed either in-person or phone visits.
intervention type: Drug
intervention name: Insulin glargine, 300 units per milliliter (U/mL)
description: Self-administered subcutaneous injection using prefilled pen once daily for 24 weeks. Dose titration to achieve fasting self-monitoring of plasma glucose (SMPG) level between 80 and 130 milligram per deciliter (mg/dL).
arm group label: Traditional
arm group label: Virtual
other name: Toujeo ®
intervention type: Drug
intervention name: Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)
description: Subcutaneous injection.
arm group label: Traditional
arm group label: Virtual
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Insulin Glargine
mesh term: Insulin Lispro
mesh term: Insulin Aspart
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Planned analysis could not be performed due to early study termination.
point of contact: 