<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/NCT03251846</url>
  </required_header>
  <id_info>
    <org_study_id>1704-059</org_study_id>
    <nct_id>NCT03251846</nct_id>
  </id_info>
  <brief_title>Pediatrics Owning Performance Study</brief_title>
  <acronym>POPS!</acronym>
  <official_title>Pediatrics Owning Performance Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospitals and Clinics of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pops! Diabetes Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospitals and Clinics of Minnesota</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>
      A more convenient blood glucose monitoring system integrated with a responsive mobile health&#xD;
      app may facilitate improved diabetes control in adolescent and young adult patients with Type&#xD;
      1 diabetes. The primary aim of this study is to determine if the POPS diabetes management&#xD;
      system can improve diabetes control in the adolescent and young adult population. The&#xD;
      investigators hypothesize that use of the POPS diabetes management device and mobile&#xD;
      application (app) will be associated with lower HbA1C after 6-months of use in adolescent and&#xD;
      young adult T1D patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-arm, single-subject clinical trial to study outcomes related to&#xD;
      device use in the pediatric diabetes population. Patients will be recruited at the Children's&#xD;
      Minnesota McNeely Diabetes Clinic and satellite clinics during routine office visits over a&#xD;
      6-month period until recruitment goals are met. Enrolled subjects will be given a POPS!&#xD;
      Device (meter, lancet/test strips, and software app) to use for 6 months with periodic&#xD;
      check-ins and follow-ups. Primary outcome, HbA1c, will be measured at baseline and 6-month&#xD;
      follow-up. Secondary aims include assessment of blood glucose testing frequency and quality&#xD;
      of life scores following 6-months of device and app use. The investigators will also describe&#xD;
      sustained use over the study period, average blood glucose and variability, and frequency of&#xD;
      hypoglycemic events (blood glucose &lt;70). Historical data for each patient will also be&#xD;
      recorded from medical records, with each patient serving as their own comparative control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</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>
    <intervention_model_description>prospective, single-arm, single-subject clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>6 months</time_frame>
    <description>Change in HbA1c from baseline to 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Testing frequency</measure>
    <time_frame>30 days prior to enrollment to 6 months post-enrollment</time_frame>
    <description>Blood glucose testing frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>30 days prior to enrollment to 6 months post-enrollment</time_frame>
    <description>Peds QL diabetes module</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average blood glucose</measure>
    <time_frame>30 days prior to enrollment to 6 months post-enrollment</time_frame>
    <description>Average blood glucose during 30 days prior to enrollment and during the 6 month intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose variability</measure>
    <time_frame>30 days prior to enrollment to 6 months post-enrollment</time_frame>
    <description>Blood glucose variability during 30 during prior to enrollment and during the 6 months of intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia</measure>
    <time_frame>6 months</time_frame>
    <description>Frequency of hypoglycemic events during intervention</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pops! One personalized mobile platform</intervention_name>
    <description>Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months. Primary outcomes will be measured at baseline and 6-month follow-up.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes, diagnosed at least 6 months prior to enrollment&#xD;
&#xD;
          2. Aged ≥10 years, ≤25 years&#xD;
&#xD;
          3. Daily insulin of any type, administered as multiple daily injections (MDI) for at&#xD;
             least 90 days prior to enrollment&#xD;
&#xD;
          4. Latest HbA1c ≥8.0%, ≤10.5%&#xD;
&#xD;
          5. Average self-blood glucose measurement frequency ≥2 per day and ≤4.5 per day based on&#xD;
             meter download spanning 28-day period prior to qualifying HbA1c measurement&#xD;
&#xD;
          6. User of iPhone 5 or above with iOS above 10.0&#xD;
&#xD;
          7. English-speaking&#xD;
&#xD;
          8. Patient must be willing to only use POPS device to check blood glucose for duration of&#xD;
             study (except in case of technical failure or emergency)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Continuous glucose monitor user at time of enrollment or considering CGM use in the&#xD;
             next 6 months&#xD;
&#xD;
          2. Concurrent participation in another study that may influence results&#xD;
&#xD;
          3. On insulin pump at time of recruitment or considering pump use in the next 6 months&#xD;
&#xD;
          4. Inability to perform self-care behaviors due to co-morbidities such as mental health&#xD;
             disorder, developmental delay, or other prohibitive physical condition (blindness,&#xD;
             etc)&#xD;
&#xD;
          5. Participation in a diabetes clinical trial intervention in the 12 months prior to&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Laura Gandrud, MD</last_name>
    <phone>651-220-6624</phone>
    <email>laura.gandrud@childrensmn.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Krista Mullen, BS</last_name>
    <phone>507-581-6000</phone>
    <email>krista.mullen@childrensmn.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospitals and Clinics of Minnesota</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laure Gandrud, MD</last_name>
      <phone>651-220-6624</phone>
      <email>laura.gandrud@childrensmn.org</email>
    </contact>
    <contact_backup>
      <last_name>Krista Mullen, BS</last_name>
      <phone>507-581-6000</phone>
      <email>krista.mullen@childrensmn.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospitals and Clinics of Minnesota</investigator_affiliation>
    <investigator_full_name>Laura Gandrud</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 1</keyword>
  <keyword>self-monitoring blood glucose</keyword>
  <keyword>diabetes mobile application</keyword>
  <keyword>diabetes management device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03251846
org study id: 1704-059
nct id: NCT03251846
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
A more convenient blood glucose monitoring system integrated with a responsive mobile health
      app may facilitate improved diabetes control in adolescent and young adult patients with Type
      1 diabetes. The primary aim of this study is to determine if the POPS diabetes management
      system can improve diabetes control in the adolescent and young adult population. The
      investigators hypothesize that use of the POPS diabetes management device and mobile
      application (app) will be associated with lower HbA1C after 6-months of use in adolescent and
      young adult T1D patients.
This is a prospective, single-arm, single-subject clinical trial to study outcomes related to
      device use in the pediatric diabetes population. Patients will be recruited at the Children's
      Minnesota McNeely Diabetes Clinic and satellite clinics during routine office visits over a
      6-month period until recruitment goals are met. Enrolled subjects will be given a POPS!
      Device (meter, lancet/test strips, and software app) to use for 6 months with periodic
      check-ins and follow-ups. Primary outcome, HbA1c, will be measured at baseline and 6-month
      follow-up. Secondary aims include assessment of blood glucose testing frequency and quality
      of life scores following 6-months of device and app use. The investigators will also describe
      sustained use over the study period, average blood glucose and variability, and frequency of
      hypoglycemic events (blood glucose <70). Historical data for each patient will also be
      recorded from medical records, with each patient serving as their own comparative control.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective, single-arm, single-subject clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: HbA1c
time frame: 6 months
description: Change in HbA1c from baseline to 6 months
measure: Testing frequency
time frame: 30 days prior to enrollment to 6 months post-enrollment
description: Blood glucose testing frequency
measure: quality of life
time frame: 30 days prior to enrollment to 6 months post-enrollment
description: Peds QL diabetes module
measure: Average blood glucose
time frame: 30 days prior to enrollment to 6 months post-enrollment
description: Average blood glucose during 30 days prior to enrollment and during the 6 month intervention
measure: Blood glucose variability
time frame: 30 days prior to enrollment to 6 months post-enrollment
description: Blood glucose variability during 30 during prior to enrollment and during the 6 months of intervention
measure: Hypoglycemia
time frame: 6 months
description: Frequency of hypoglycemic events during intervention
intervention type: Device
intervention name: Pops! One personalized mobile platform
description: Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months. Primary outcomes will be measured at baseline and 6-month follow-up.
criteria: 
gender: All
minimum age: 10 Years
maximum age: 25 Years
healthy volunteers: No
last name: Laura Gandrud, MD
phone: 651-220-6624
email: laura.gandrud@childrensmn.org
last name: Krista Mullen, BS
phone: 507-581-6000
email: krista.mullen@childrensmn.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Hospitals and Clinics of Minnesota
investigator full name: Laura Gandrud
investigator title: Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No