<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/NCT03758430</url>
  </required_header>
  <id_info>
    <org_study_id>17111</org_study_id>
    <secondary_id>F3Z-MC-IORA</secondary_id>
    <nct_id>NCT03758430</nct_id>
  </id_info>
  <brief_title>A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes</brief_title>
  <official_title>Technology-supported, Meal-centric, Insulin Dosing for Optimized Post-prandial Glucose Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Joslin Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to determine whether combining meal, glucose, and insulin&#xD;
      data in a web-based system will improve management of type 1 diabetes (T1D). No study drug&#xD;
      will be given. The study will last about 18 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2019</start_date>
  <completion_date type="Actual">August 7, 2020</completion_date>
  <primary_completion_date type="Actual">August 7, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Change from Baseline to Week 16 in HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Combined Diabetes Management Data</arm_group_label>
    <description>Participants with type 1 diabetes will use a meal tagging application (app) and fitness tracker. They will upload these data to a web portal where they will be matched with data from their continuous glucose monitor and insulin pump. Combined data will be used for diabetes management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal-Tagging App</intervention_name>
    <description>Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.</description>
    <arm_group_label>Combined Diabetes Management Data</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fitness Tracker</intervention_name>
    <description>Fitness tracker will be worn around the clock for 16 weeks.</description>
    <arm_group_label>Combined Diabetes Management Data</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with T1D&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  T1D by clinical diagnosis for &gt; 3 years&#xD;
&#xD;
          -  Insulin pump use &gt; 3 months: must use one of the following pump types: Animas Ping and&#xD;
             Vibe, Insulet Omnipod, Medtronic 523/723 and 530G, Tandem t:slim and t:flex&#xD;
&#xD;
          -  Continuous Glucose Monitor (CGM) &gt; 3 months and current use of Dexcom G5 at least 6&#xD;
             out of 7 days per week&#xD;
&#xD;
          -  HbA1c 7.0-9.5%&#xD;
&#xD;
          -  Must have iPhone (meal-tagging app has been built on iOS)&#xD;
&#xD;
          -  Personal computer for uploading of pump and CGM devices&#xD;
&#xD;
          -  Willingness to follow study protocol including tagging food data&#xD;
&#xD;
          -  Comfort speaking, reading, and writing English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals currently using a hybrid closed-loop system (e.g., Medtronic 670G)&#xD;
&#xD;
          -  Individuals planning to follow a specific diet plan for weight loss&#xD;
&#xD;
          -  Inability to consume &quot;common meals&quot;&#xD;
&#xD;
          -  Gastroparesis;&#xD;
&#xD;
          -  Eating disorder&#xD;
&#xD;
          -  Evidence of missed insulin meal-time insulin boluses on pump download&#xD;
&#xD;
          -  Use of medications that can affect blood glucose levels (such as SGLT inhibitors,&#xD;
             steroid, beta agonists)&#xD;
&#xD;
          -  Use of medications that affect gastric emptying (such as GLP agonists, pramlinitide)&#xD;
&#xD;
          -  Alcohol abuse&#xD;
&#xD;
          -  Pre-conception, pregnancy, or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>August 20, 2020</last_update_submitted>
  <last_update_submitted_qc>August 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</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, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03758430
org study id: 17111
secondary id: F3Z-MC-IORA
nct id: NCT03758430
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to determine whether combining meal, glucose, and insulin
      data in a web-based system will improve management of type 1 diabetes (T1D). No study drug
      will be given. The study will last about 18 weeks.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline to Week 16 in Hemoglobin A1c (HbA1c)
time frame: Baseline to Week 16
description: Change from Baseline to Week 16 in HbA1c
measure: Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals
time frame: Baseline to Week 16
description: Change from Baseline to Week 16 in Post-Prandial Glucose Concentrations Following Commonly Eaten Meals
arm group label: Combined Diabetes Management Data
description: Participants with type 1 diabetes will use a meal tagging application (app) and fitness tracker. They will upload these data to a web portal where they will be matched with data from their continuous glucose monitor and insulin pump. Combined data will be used for diabetes management.
intervention type: Other
intervention name: Meal-Tagging App
description: Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.
arm group label: Combined Diabetes Management Data
intervention type: Device
intervention name: Fitness Tracker
description: Fitness tracker will be worn around the clock for 16 weeks.
arm group label: Combined Diabetes Management Data
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No