<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/NCT04484779</url>
  </required_header>
  <id_info>
    <org_study_id>16928</org_study_id>
    <secondary_id>F3Z-MC-IOQY</secondary_id>
    <nct_id>NCT04484779</nct_id>
  </id_info>
  <brief_title>A Study of an Insulin Management System in Participants With Type 1 or Type 2 Diabetes</brief_title>
  <official_title>User Experience and Daily Use Patterns With the Integrated Insulin Management (IIM) System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the user experience of an integrated insulin&#xD;
      management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is&#xD;
      comprised of an insulin injection pen with a data transmission module and blood glucose meter&#xD;
      which are connected to a mobile phone application. The application will be used to record and&#xD;
      track diabetes-data related information.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">December 22, 2020</completion_date>
  <primary_completion_date type="Actual">December 22, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Total and Domain Specific Score of the MAUQ for Standalone mHealth Apps Used by Patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Ease of Use of the IIM System</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Overall Ease of Use of the IIM System Assessed by the Participant Feedback Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likelihood of Site to Recommend the IIM System</measure>
    <time_frame>10 Weeks</time_frame>
    <description>Likelihood of Site to Recommend the IIM System Assessed by the Site Feedback Form</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>IIM System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IIM system is comprised of an insulin lispro pen and/or an insulin glargine pen (both U-100), an investigational mobile medical application (MMA) that transmits data to cloud storage, an investigational Bluetooth Low Energy® (BLE)-paired insulin data transmission (IDT) module and a compatible commercially available BLE-paired blood glucose meter (BGM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IIM System</intervention_name>
    <description>IIM System</description>
    <arm_group_label>IIM System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Lispro and/or Insulin Glargine</intervention_name>
    <description>Administered subcutaneously (SC)</description>
    <arm_group_label>IIM System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed (clinically) with type 1 diabetes (T1D) for at least 1 year or type 2&#xD;
             diabetes (T2D) for at least 6 months.&#xD;
&#xD;
          -  Using insulin injection regimen of basal/bolus or basal only for 3 months prior to&#xD;
             screening, which includes:&#xD;
&#xD;
               -  for bolus insulin (U-100) - a rapid-acting insulin analog (glulisine, lispro, or&#xD;
                  aspart).&#xD;
&#xD;
               -  for basal insulin - degludec (U-100 or U-200), detemir (U-100), or glargine (U-&#xD;
                  100 or U-300).&#xD;
&#xD;
          -  Participants with T2D may be on ≤ 3 anti-hyperglycemic medications in addition to&#xD;
             insulin, including alpha-glucosidase inhibitors, dipeptidyl peptidase 4 (DPP-4)&#xD;
             inhibitors, glucagon-like peptide 1 receptor agonist (GLP-1 RA; oral or injectable),&#xD;
             meglitinides, metformin, sodium-glucose cotransporter-2 inhibitors (SGLTi-2),&#xD;
             sulfonylureas, or thiazolidinediones consistent with product labeling.&#xD;
&#xD;
          -  Participants with T1D must be on insulin only.&#xD;
&#xD;
          -  Have point-of-care hemoglobin A1c (HbA1c) value of ≤11% at screening.&#xD;
&#xD;
          -  Must be able to self-inject insulin dose (basal or basal/bolus) without assistance.&#xD;
&#xD;
          -  If using Continuous Glucose Monitoring or Flash Glucose Monitoring device, must agree&#xD;
             to stop use throughout duration of trial.&#xD;
&#xD;
          -  Must be able to read and speak English.&#xD;
&#xD;
          -  Able and willing to use only study-provided insulin Basaglar and/or Humalog for&#xD;
             duration of trial.&#xD;
&#xD;
          -  Able and willing to follow insulin regimen specified by investigator throughout&#xD;
             duration of trial, insulin dose may be titrated at investigator's discretion.&#xD;
&#xD;
          -  Have no physical or cognitive disabilities that would, in the opinion of the&#xD;
             investigator, preclude participant from using sponsor-provided iOS device for study&#xD;
             activities and comply with study requirements.&#xD;
&#xD;
          -  Agree not to post any personal medical data, pictures of the IIM system or information&#xD;
             related to the study on any website or social media site (for example, Facebook,&#xD;
             Twitter, LinkedIn, etc.).&#xD;
&#xD;
          -  Have refrigeration in home for storage of insulin.&#xD;
&#xD;
          -  Women of childbearing potential participating:&#xD;
&#xD;
               -  Cannot be pregnant or intend to become pregnant during the trial period&#xD;
&#xD;
               -  Cannot be breastfeeding (including the use of a breast pump)&#xD;
&#xD;
               -  Must remain abstinent or&#xD;
&#xD;
               -  Must use 1 highly effective method (less than 1% failure rate) of contraception&#xD;
                  or a combination of 2 effective methods of contraception for the entirety of the&#xD;
                  study and&#xD;
&#xD;
               -  Test negative for pregnancy based on a urine pregnancy test at the time of&#xD;
                  screening. Additional local urine pregnancy tests may be conducted for duration&#xD;
                  of trial at discretion of investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If not able to take the basal insulin dose in 1 injection per day.&#xD;
&#xD;
          -  Have experienced an episode of severe hypoglycemia (defined as requiring assistance&#xD;
             due to neurologically disabling hypoglycemia) within 3 months prior to screening.&#xD;
&#xD;
          -  Have hypoglycemia unawareness as judged by the investigator.&#xD;
&#xD;
          -  Have had 1 or more emergency room visits or hospitalization due to poor glucose&#xD;
             control (hyperglycemia or diabetic ketoacidosis [DKA]) within 3 months prior to&#xD;
             screening.&#xD;
&#xD;
          -  History of renal transplantation, receiving renal dialysis, or diagnosed with stage IV&#xD;
             chronic kidney disease.&#xD;
&#xD;
          -  Any of the following cardiovascular conditions within 6 months prior to screening: i.&#xD;
             acute myocardial infarction (MI) ii. cerebrovascular accident (stroke) iii. unstable&#xD;
             angina, or iv. hospitalization due to congestive heart failure (CHF)&#xD;
&#xD;
          -  Presence or history of severe congestive heart failure (New York Heart Association&#xD;
             Class IV [CCNYHA 1994]).&#xD;
&#xD;
          -  Have history of or clinical signs of liver disease (for example, acute or chronic&#xD;
             hepatitis, or cirrhosis).&#xD;
&#xD;
          -  Have active or untreated malignancy except basal cell or squamous cell skin cancer.&#xD;
&#xD;
          -  Have any hypersensitivity or allergy to any of the insulins or excipients used in this&#xD;
             trial.&#xD;
&#xD;
          -  Have vision loss or vision impairment that does not allow recognition of MMA screen&#xD;
             features.&#xD;
&#xD;
          -  Have impaired dexterity which limits ability to use injection device or mobile MMA.&#xD;
&#xD;
          -  Are currently enrolled in any other clinical study involving an investigational&#xD;
             product or any other type of medical research judged not to be scientifically or&#xD;
             medically compatible with this study.&#xD;
&#xD;
          -  Have participated, within the last 30 days, in a clinical study involving an&#xD;
             investigational product. If the previous investigational product has a long halflife,&#xD;
             5 half-lives or 30 days (whichever is longer) should have passed.&#xD;
&#xD;
          -  Have previously completed or withdrawn from this study.&#xD;
&#xD;
          -  Have previously used or are currently using an approved or investigational connected&#xD;
             pen system.&#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>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-532-0186 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>Medical Investigations Inc.</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research, Inc.</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes &amp; Endocrinology, P.A.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731-4309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes &amp; Endocrinology, P.A.</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rainier Clinical Research Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2021</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 2</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 Glargine</mesh_term>
    <mesh_term>Insulin Lispro</mesh_term>
  </intervention_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/NCT04484779
org study id: 16928
secondary id: F3Z-MC-IOQY
nct id: NCT04484779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to investigate the user experience of an integrated insulin
      management system (IIM) in participants with type 1 or type 2 diabetes. The IIM system is
      comprised of an insulin injection pen with a data transmission module and blood glucose meter
      which are connected to a mobile phone application. The application will be used to record and
      track diabetes-data related information.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
time frame: 10 Weeks
description: Total and Domain Specific Score of the MAUQ for Standalone mHealth Apps Used by Patients
measure: Overall Ease of Use of the IIM System
time frame: 10 Weeks
description: Overall Ease of Use of the IIM System Assessed by the Participant Feedback Form
measure: Likelihood of Site to Recommend the IIM System
time frame: 10 Weeks
description: Likelihood of Site to Recommend the IIM System Assessed by the Site Feedback Form
arm group label: IIM System
arm group type: Experimental
description: The IIM system is comprised of an insulin lispro pen and/or an insulin glargine pen (both U-100), an investigational mobile medical application (MMA) that transmits data to cloud storage, an investigational Bluetooth Low Energy® (BLE)-paired insulin data transmission (IDT) module and a compatible commercially available BLE-paired blood glucose meter (BGM).
intervention type: Device
intervention name: IIM System
description: IIM System
arm group label: IIM System
intervention type: Drug
intervention name: Insulin Lispro and/or Insulin Glargine
description: Administered subcutaneously (SC)
arm group label: IIM System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-532-0186 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Insulin
mesh term: Insulin Glargine
mesh term: Insulin Lispro
sharing ipd: No