<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/NCT04431947</url>
  </required_header>
  <id_info>
    <org_study_id>20-0375</org_study_id>
    <secondary_id>K12DK094712</secondary_id>
    <nct_id>NCT04431947</nct_id>
  </id_info>
  <brief_title>Impact of Hybrid Closed-Loop Systems on Sleep and Psychosocial Outcomes in Youth With T1D and Their Parents</brief_title>
  <official_title>Sleep and Psychosocial Outcomes After Initiation of Advanced Hybrid Closed-Loop Insulin Delivery Systems in Youth With Type 1 Diabetes and Their Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep&#xD;
      in youth with type 1 diabetes and their parents. Activity watches, surveys and device&#xD;
      downloads are used to evaluate sleep in these participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sleep is important for everyone, including youth with type 1 diabetes. New technology has&#xD;
      shown improvements in glycemic variability, especially overnight. This study evaluates the&#xD;
      impact of advanced hybrid closed-loop insulin delivery systems on sleep for both youth with&#xD;
      type 1 diabetes and their parents. Study measures include wearing an actigraphy watch and&#xD;
      completing a sleep diary for 7 days and taking surveys on sleep and psychosocial measures.&#xD;
      Study measures occur prior to starting the hybrid closed-loop system, immediately after&#xD;
      starting the system and at 3 and 6 months after starting the system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2020</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</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>Duration of Sleep</measure>
    <time_frame>End of study (6 months)</time_frame>
    <description>Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact on Diabetes Distress</measure>
    <time_frame>End of study (6 months)</time_frame>
    <description>Change in diabetes-related distress using the validated Problem Areas in Diabetes survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on Quality of Life</measure>
    <time_frame>End of study (6 months)</time_frame>
    <description>Change in quality of life using the validated survey Pediatric Quality of Life Inventory Diabetes Module (PedsQL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on Fear of Hypoglycemia</measure>
    <time_frame>End of study (6 months)</time_frame>
    <description>Change in fear of hypoglycemia using the validated hypoglycemia fear survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on Perceptions of Diabetes Technology</measure>
    <time_frame>End of study (6 months)</time_frame>
    <description>Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on Hybrid Closed-Loop System Use Perceptions</measure>
    <time_frame>End of study (6 months)</time_frame>
    <description>Change in perceptions of hybrid-closed loop systems using the validated INSPIRE survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Sleep on Glycemic Variability</measure>
    <time_frame>End of study (6 months)</time_frame>
    <description>Correlation of sleep duration and glycemic variability using hybrid closed loop device download to analyze time in range, time with low glucose and time with high glucose</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Youth</arm_group_label>
    <description>Youth, between the ages of 2 and 17, with type 1 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent</arm_group_label>
    <description>Parents of youth with type 1 diabetes</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Youth with type 1 diabetes and a parent who resides with the youth.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child diagnosed with type 1 diabetes for at least 3 months&#xD;
&#xD;
          -  Child receives clinical care at the Barbara Davis Center for Diabetes&#xD;
&#xD;
          -  Child starting an advanced HCL system as part of routine diabetes care&#xD;
&#xD;
          -  Child currently living with a parent who is willing to complete surveys for this study&#xD;
&#xD;
          -  Family able to read and speak English&#xD;
&#xD;
          -  Parent lives at home with the child with type 1 diabetes&#xD;
&#xD;
          -  Parent able to read and speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child has an active underlying sleep disorder, such as narcolepsy, insomnia or&#xD;
             untreated sleep apnea&#xD;
&#xD;
          -  Child participating in an interventional research protocol&#xD;
&#xD;
          -  Child unable to complete study procedures&#xD;
&#xD;
          -  Parent has an active underlying sleep disorder, such as narcolepsy, insomnia or&#xD;
             untreated sleep apnea&#xD;
&#xD;
          -  Parent unable to complete study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Erin Cobry, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado, Barbara Davis Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>April 21, 2022</last_update_submitted>
  <last_update_submitted_qc>April 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 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, 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/NCT04431947
org study id: 20-0375
secondary id: K12DK094712
nct id: NCT04431947
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of the hybrid closed-loop insulin delivery systems on sleep
      in youth with type 1 diabetes and their parents. Activity watches, surveys and device
      downloads are used to evaluate sleep in these participants.
Sleep is important for everyone, including youth with type 1 diabetes. New technology has
      shown improvements in glycemic variability, especially overnight. This study evaluates the
      impact of advanced hybrid closed-loop insulin delivery systems on sleep for both youth with
      type 1 diabetes and their parents. Study measures include wearing an actigraphy watch and
      completing a sleep diary for 7 days and taking surveys on sleep and psychosocial measures.
      Study measures occur prior to starting the hybrid closed-loop system, immediately after
      starting the system and at 3 and 6 months after starting the system.
observational model: Cohort
time perspective: Prospective
measure: Duration of Sleep
time frame: End of study (6 months)
description: Change in duration of sleep before and after starting the advanced hybrid closed-loop system using surveys and activity watches
measure: Impact on Diabetes Distress
time frame: End of study (6 months)
description: Change in diabetes-related distress using the validated Problem Areas in Diabetes survey
measure: Impact on Quality of Life
time frame: End of study (6 months)
description: Change in quality of life using the validated survey Pediatric Quality of Life Inventory Diabetes Module (PedsQL)
measure: Impact on Fear of Hypoglycemia
time frame: End of study (6 months)
description: Change in fear of hypoglycemia using the validated hypoglycemia fear survey
measure: Impact on Perceptions of Diabetes Technology
time frame: End of study (6 months)
description: Change in diabetes technology perceptions using the validated survey Diabetes Technology Questionnaire
measure: Impact on Hybrid Closed-Loop System Use Perceptions
time frame: End of study (6 months)
description: Change in perceptions of hybrid-closed loop systems using the validated INSPIRE survey
measure: Impact of Sleep on Glycemic Variability
time frame: End of study (6 months)
description: Correlation of sleep duration and glycemic variability using hybrid closed loop device download to analyze time in range, time with low glucose and time with high glucose
arm group label: Youth
description: Youth, between the ages of 2 and 17, with type 1 diabetes
arm group label: Parent
description: Parents of youth with type 1 diabetes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
last name: Erin Cobry, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No