<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/NCT03830216</url>
  </required_header>
  <id_info>
    <org_study_id>CM 2018-01</org_study_id>
    <nct_id>NCT03830216</nct_id>
  </id_info>
  <brief_title>Connected Pens for Diabetes Study</brief_title>
  <acronym>CUPID</acronym>
  <official_title>Connected Pens for Diabetes Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Companion Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Companion Medical, Inc.</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_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate the impact of a wireless smart insulin pen and&#xD;
      smartphone-based bolus advisor on clinical and psychosocial outcomes in insulin-treated&#xD;
      diabetes mellitus patients after 3 months of use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a prospective, randomized, controlled treatment design. The study device will be&#xD;
      used for multiple daily injection (MDI) therapy of insulin. The participant will interact&#xD;
      with the study device in the uncontrolled environment of the participant's daily life. The&#xD;
      study protocol is designed to yield meaningful data to determine clinical and psychosocial&#xD;
      benefits of using the study device. The study will evaluate the study device as an&#xD;
      intervention versus a control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Selective inclusion/exclusion criteria led to low enrollment which was not viable for the&#xD;
    sponsor and site.&#xD;
  </why_stopped>
  <start_date type="Actual">May 30, 2019</start_date>
  <completion_date type="Actual">November 12, 2019</completion_date>
  <primary_completion_date type="Actual">November 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, randomized, controlled treatment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants in the control arm will use a blinded device. All participants will be blinded to baseline time-in-range and HbA1c measures. Investigators will be blinded to professional CGM baseline time-in-range.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CGM time in range</measure>
    <time_frame>3 months</time_frame>
    <description>Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute change in HbA1c</measure>
    <time_frame>3 months</time_frame>
    <description>Average change in HbA1c from Baseline to Month 3 compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean sensor glucose (mg/dL)</measure>
    <time_frame>3 months</time_frame>
    <description>Mean sensor glucose will be measured on the final blinded, professional CGM session performed at the end of the 3 month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent CGM time spent in hypoglycemia (70-54 mg/dl, &lt; 54 mg/dL)</measure>
    <time_frame>3 months</time_frame>
    <description>Percent of time spent in hypoglycemia from Baseline to Month 3 will be compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent CGM time spent in hyperglycemic range (&gt;180 mg/dl, &gt;250 mg/dL)</measure>
    <time_frame>3 months</time_frame>
    <description>Percent of time spent in hyperglycemia from Baseline to Month 3 will be compared between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient reported outcomes - ADDQoL</measure>
    <time_frame>3 months</time_frame>
    <description>The Audit of Diabetes Dependent Quality of Life (ADDQoL) Questionnaire measures diabetes-specific quality of life. The 19 items measure the impact of diabetes on specific aspects of life and the importance of these aspects of life for quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient reported outcomes - DTSQ</measure>
    <time_frame>3 months</time_frame>
    <description>The Diabetes Treatment Satisfaction Questionnaire (DTSQ) measures diabetes treatment satisfaction. The 8 items measure treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient reported outcomes - IDSS</measure>
    <time_frame>3 months</time_frame>
    <description>The Insulin Delivery Satisfaction Survey (IDSS) measures insulin delivery device satisfaction. The 14 items measure provides a comprehensive profile of sources of device satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient reported outcomes - HCS</measure>
    <time_frame>3 months</time_frame>
    <description>The Hypoglycemic Confidence Scale (HCS) Hypoglycemic measures the degree to which patients feel able, secure, and comfortable regarding their ability to avoid hypoglycemia.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in glycemic variability (CV and SD)</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of missed bolus doses and missed basal doses</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of SMBG measurements in participants not using CGM</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of insulin dose administrations</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects will administer prandial insulin to manage their diabetes using a connected insulin pen and smartphone app with integrated dose calculator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Study subjects will administer prandial insulin to manage their diabetes using an inactive connected insulin pen without smartphone app.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Connected insulin pen and smartphone app</intervention_name>
    <description>The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is paired with a smartphone app with dose calculator.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inactive connected insulin pen without smartphone app</intervention_name>
    <description>The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is inactive and not paired with a smartphone app or dose calculator.</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The participant is ≥ 18 years of age&#xD;
&#xD;
          2. The participant has Type 1 OR Type 2 diabetes and is being treated with intensive&#xD;
             insulin therapy via injection for ≥ 3 months. Intensive insulin therapy is defined as&#xD;
             at least one long acting insulin dose and two or more short acting insulin doses per&#xD;
             day.&#xD;
&#xD;
          3. Glycated hemoglobin (HbA1c) ≥ 7.5%).&#xD;
&#xD;
          4. The participant is a current iPhone user for over 30 days.&#xD;
&#xD;
          5. Participant adjusts meal insulin doses based on carbohydrate content of meals.&#xD;
&#xD;
          6. The participant is fluent in the English language.&#xD;
&#xD;
          7. The participant and the investigator understand participant obligations and agree that&#xD;
             the participant is willing and able to complete the study visits.&#xD;
&#xD;
          8. Patients prandial insulin need must be &lt;30 U per meal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The participant has been using unblinded CGM for less than 6 months.&#xD;
&#xD;
          2. The participant uses pre-mixed insulin.&#xD;
&#xD;
          3. Current use of a smart insulin pen.&#xD;
&#xD;
          4. Use of sliding scale insulin therapy that determines insulin dosages based exclusively&#xD;
             on specific blood glucose results&#xD;
&#xD;
          5. Used systemic oral or inhaled steroids for more than 7 days within the last 3 months&#xD;
&#xD;
          6. Oral anti-diabetic agents, with the exception of metformin&#xD;
&#xD;
          7. Injectable anti-diabetic agents other than insulin&#xD;
&#xD;
          8. The participant is legally blind or has below specified best-corrected vision level.&#xD;
&#xD;
          9. Diagnosed with any clinically significant infectious disease or major organ system&#xD;
             disease, such as gastroparesis or renal disease (at Investigator's discretion)&#xD;
&#xD;
         10. The participant is pregnant, lactating, or plans to become pregnant in the next 6&#xD;
             months.&#xD;
&#xD;
         11. The participant is currently participating in another clinical study that may preclude&#xD;
             the participant from meeting the obligations of this study.&#xD;
&#xD;
         12. The participant has any additional condition(s) (medical, social, or psychosocial)&#xD;
             that in the investigator's opinion would warrant exclusion from the study or prevent&#xD;
             the participant from completing or complying with the study requirements.&#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>David Ahn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hoag Memorial Hospital Presbyterian</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mary &amp; Dick Allen Diabetes Center, Hoag Memorial Hospital Presbyterian</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</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>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 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>
  </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>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03830216
org study id: CM 2018-01
nct id: NCT03830216
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of the study is to evaluate the impact of a wireless smart insulin pen and
      smartphone-based bolus advisor on clinical and psychosocial outcomes in insulin-treated
      diabetes mellitus patients after 3 months of use.
The study is a prospective, randomized, controlled treatment design. The study device will be
      used for multiple daily injection (MDI) therapy of insulin. The participant will interact
      with the study device in the uncontrolled environment of the participant's daily life. The
      study protocol is designed to yield meaningful data to determine clinical and psychosocial
      benefits of using the study device. The study will evaluate the study device as an
      intervention versus a control group.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized, controlled treatment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Participants in the control arm will use a blinded device. All participants will be blinded to baseline time-in-range and HbA1c measures. Investigators will be blinded to professional CGM baseline time-in-range.
measure: CGM time in range
time frame: 3 months
description: Percent CGM time in range (70-180 mg/dL) at 90 days, measured over 14 day period
measure: Absolute change in HbA1c
time frame: 3 months
description: Average change in HbA1c from Baseline to Month 3 compared between groups
measure: Mean sensor glucose (mg/dL)
time frame: 3 months
description: Mean sensor glucose will be measured on the final blinded, professional CGM session performed at the end of the 3 month
measure: Percent CGM time spent in hypoglycemia (70-54 mg/dl, < 54 mg/dL)
time frame: 3 months
description: Percent of time spent in hypoglycemia from Baseline to Month 3 will be compared between groups
measure: Percent CGM time spent in hyperglycemic range (>180 mg/dl, >250 mg/dL)
time frame: 3 months
description: Percent of time spent in hyperglycemia from Baseline to Month 3 will be compared between groups
measure: Change in patient reported outcomes - ADDQoL
time frame: 3 months
description: The Audit of Diabetes Dependent Quality of Life (ADDQoL) Questionnaire measures diabetes-specific quality of life. The 19 items measure the impact of diabetes on specific aspects of life and the importance of these aspects of life for quality of life.
measure: Change in patient reported outcomes - DTSQ
time frame: 3 months
description: The Diabetes Treatment Satisfaction Questionnaire (DTSQ) measures diabetes treatment satisfaction. The 8 items measure treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
measure: Change in patient reported outcomes - IDSS
time frame: 3 months
description: The Insulin Delivery Satisfaction Survey (IDSS) measures insulin delivery device satisfaction. The 14 items measure provides a comprehensive profile of sources of device satisfaction.
measure: Change in patient reported outcomes - HCS
time frame: 3 months
description: The Hypoglycemic Confidence Scale (HCS) Hypoglycemic measures the degree to which patients feel able, secure, and comfortable regarding their ability to avoid hypoglycemia.
measure: Change in glycemic variability (CV and SD)
time frame: 3 months
measure: Number of missed bolus doses and missed basal doses
time frame: 3 months
measure: Number of SMBG measurements in participants not using CGM
time frame: 3 months
measure: Number of insulin dose administrations
time frame: 3 months
arm group label: Treatment Arm
arm group type: Experimental
description: Study subjects will administer prandial insulin to manage their diabetes using a connected insulin pen and smartphone app with integrated dose calculator.
arm group label: Control Arm
arm group type: Sham Comparator
description: Study subjects will administer prandial insulin to manage their diabetes using an inactive connected insulin pen without smartphone app.
intervention type: Device
intervention name: Connected insulin pen and smartphone app
description: The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is paired with a smartphone app with dose calculator.
arm group label: Treatment Arm
intervention type: Device
intervention name: Inactive connected insulin pen without smartphone app
description: The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is inactive and not paired with a smartphone app or dose calculator.
arm group label: Control Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Ahn, MD
role: Principal Investigator
affiliation: Hoag Memorial Hospital Presbyterian
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Insulin
mesh term: Insulin, Globin Zinc
sharing ipd: Undecided