<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/NCT02974309</url>
  </required_header>
  <id_info>
    <org_study_id>RDK110528A</org_study_id>
    <nct_id>NCT02974309</nct_id>
  </id_info>
  <brief_title>Family Routines Enhancing Adolescent Diabetes by Optimizing Management</brief_title>
  <acronym>FREADOM</acronym>
  <official_title>Extending Sleep to Improve Glycemic Control in Pediatric Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A three month randomized study to examine the potential benefits of sleep extension in tandem&#xD;
      with clinical trial on diabetes management in youth with type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 Diabetes (T1DM) is one of the most common chronic medical conditions that occur in&#xD;
      children. More than two-thirds of these young patients struggle to maintain optimal glycemic&#xD;
      control. On a seemingly unrelated front, insufficient sleep has become a public health crisis&#xD;
      as less than 30% of youth achieve the recommended number of hours on school nights. Prior&#xD;
      research has supported that sleep disturbances contribute to elevated glucose levels and have&#xD;
      a significant impact on memory, attention, and planning. These skills are essential to&#xD;
      effective diabetes management. Despite the link between sleep and diabetes, no research has&#xD;
      examined the benefits of an intervention to help these youth achieve a healthy sleep&#xD;
      duration. To that end, our primary objective is to determine the effect of sleep extension on&#xD;
      glycemic control and psychosocial functioning. Our secondary objective is to determine&#xD;
      mediators and moderators of effect. The central hypothesis is that an increase in sleep&#xD;
      duration will lower glucose levels and improve behavioral ratings (internalizing,&#xD;
      externalizing, and classroom behaviors). Our primary study aims are to (1) Test if&#xD;
      lengthening sleep improves glycemic control and psychosocial function in youth with T1DM; (2)&#xD;
      Assess putative mechanisms for the effects of sleep extension on glucose and psychosocial&#xD;
      function; and (3) Examine the possible moderating effect of pre-existing sleep parameters and&#xD;
      sociodemographic variables that modify the impact of sleep extension. A secondary aim is&#xD;
      exploratory to examine additional pre-selected mediators and moderators. In the proposed&#xD;
      randomized study, up to 175 youth with T1DM will be assigned to a Sleep Extension or a&#xD;
      supportive routines condition. The Sleep Extension lengthens youth's time in bed to allow for&#xD;
      a healthy sleep duration on a consistent basis, whereas the supportive routines condition&#xD;
      reinforces daytime and nighttime activities. We will test the impact of sleep extension on&#xD;
      key indices of glycemic control (average glucose levels and % time hyperglycemia using&#xD;
      continuous glucose monitors and HbA1C) as well as putative mechanisms of effect (e.g., heart&#xD;
      rate variability and salivary cortisol levels) and participant characteristics that might&#xD;
      mitigate the benefits of sleep extension (e.g., sleep-disordered breathing, adherence, and&#xD;
      SES). Once our aims are achieved and a causal link is established, the proposed Sleep&#xD;
      Extension intervention will advance knowledge about the role of sleep in diabetes management&#xD;
      and provide a beneficial intervention to help youth with T1DM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c</measure>
    <time_frame>3 months</time_frame>
    <description>A measure of glucose control</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose Levels via continuous glucose monitor</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Glucose levels will be measured at regular intervals using a subcutaneous continuous glucose monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Duration</measure>
    <time_frame>3 months</time_frame>
    <description>Sleep duration will be measured using a combination of wrist actigraphy and polysomnography data.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Diabetes Self-Management</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Diabetes self-management and care activities will be assessed using the Diabetes Self-Management Profile for Flexible Regimes, Self- and Parent-proxy reports</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to Diabetes Management</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Adherence to diabetes management will be measured using the average daily manual glucose measurements from a personal glucometer (i.e. finger sticks)</description>
  </other_outcome>
  <other_outcome>
    <measure>Polysomnographic Sleep Architecture</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Sleep architecture will be measured as percent time spent sleeping in the different stages of sleep (NREM 1, 2, 3, REM) using an in-home polysomnography system.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Quality of Life will be measured using an aggregate of the Pediatric Quality of Life Inventory (PedsQL) Core 4.0 and Diabetes 3.2 modules.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cortisol</measure>
    <time_frame>1 and 3 months</time_frame>
    <description>Morning and evening Cortisol levels will be measured using a saliva collection device</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">175</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Sleep Extension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>All youth in this condition are asked to follow the routine that their clinical team has established.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Extension</intervention_name>
    <description>All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer</description>
    <arm_group_label>Sleep Extension</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine</intervention_name>
    <description>All youth in this condition are asked to follow the routines set by their clinical care team.</description>
    <arm_group_label>Routine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neurological, developmental, or psychiatric condition that in the opinion of the PI&#xD;
             would significantly interfere with sleep or participation&#xD;
&#xD;
          -  not hospitalized within the previous month prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle M Perfect, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UA College of Education</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michelle M Perfect, PhD</last_name>
    <phone>5206261128</phone>
    <email>mperfect@email.arizona.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Pediatric Endocrinology Clinic</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michelle M Perfect, Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mark Wheeler, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cyndi Chin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stuart Quan, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>April 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Youth</keyword>
  <keyword>Diabetes Management</keyword>
  <keyword>Sleep</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>Yes</sharing_ipd>
    <ipd_description>Upon request.</ipd_description>
  </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/NCT02974309
org study id: RDK110528A
nct id: NCT02974309
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A three month randomized study to examine the potential benefits of sleep extension in tandem
      with clinical trial on diabetes management in youth with type 1 diabetes.
Type 1 Diabetes (T1DM) is one of the most common chronic medical conditions that occur in
      children. More than two-thirds of these young patients struggle to maintain optimal glycemic
      control. On a seemingly unrelated front, insufficient sleep has become a public health crisis
      as less than 30% of youth achieve the recommended number of hours on school nights. Prior
      research has supported that sleep disturbances contribute to elevated glucose levels and have
      a significant impact on memory, attention, and planning. These skills are essential to
      effective diabetes management. Despite the link between sleep and diabetes, no research has
      examined the benefits of an intervention to help these youth achieve a healthy sleep
      duration. To that end, our primary objective is to determine the effect of sleep extension on
      glycemic control and psychosocial functioning. Our secondary objective is to determine
      mediators and moderators of effect. The central hypothesis is that an increase in sleep
      duration will lower glucose levels and improve behavioral ratings (internalizing,
      externalizing, and classroom behaviors). Our primary study aims are to (1) Test if
      lengthening sleep improves glycemic control and psychosocial function in youth with T1DM; (2)
      Assess putative mechanisms for the effects of sleep extension on glucose and psychosocial
      function; and (3) Examine the possible moderating effect of pre-existing sleep parameters and
      sociodemographic variables that modify the impact of sleep extension. A secondary aim is
      exploratory to examine additional pre-selected mediators and moderators. In the proposed
      randomized study, up to 175 youth with T1DM will be assigned to a Sleep Extension or a
      supportive routines condition. The Sleep Extension lengthens youth's time in bed to allow for
      a healthy sleep duration on a consistent basis, whereas the supportive routines condition
      reinforces daytime and nighttime activities. We will test the impact of sleep extension on
      key indices of glycemic control (average glucose levels and % time hyperglycemia using
      continuous glucose monitors and HbA1C) as well as putative mechanisms of effect (e.g., heart
      rate variability and salivary cortisol levels) and participant characteristics that might
      mitigate the benefits of sleep extension (e.g., sleep-disordered breathing, adherence, and
      SES). Once our aims are achieved and a causal link is established, the proposed Sleep
      Extension intervention will advance knowledge about the role of sleep in diabetes management
      and provide a beneficial intervention to help youth with T1DM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: HbA1c
time frame: 3 months
description: A measure of glucose control
measure: Glucose Levels via continuous glucose monitor
time frame: 1 and 3 months
description: Glucose levels will be measured at regular intervals using a subcutaneous continuous glucose monitor
measure: Sleep Duration
time frame: 3 months
description: Sleep duration will be measured using a combination of wrist actigraphy and polysomnography data.
measure: Diabetes Self-Management
time frame: 1 and 3 months
description: Diabetes self-management and care activities will be assessed using the Diabetes Self-Management Profile for Flexible Regimes, Self- and Parent-proxy reports
measure: Adherence to Diabetes Management
time frame: 1 and 3 months
description: Adherence to diabetes management will be measured using the average daily manual glucose measurements from a personal glucometer (i.e. finger sticks)
measure: Polysomnographic Sleep Architecture
time frame: 1 and 3 months
description: Sleep architecture will be measured as percent time spent sleeping in the different stages of sleep (NREM 1, 2, 3, REM) using an in-home polysomnography system.
measure: Quality of Life
time frame: 1 and 3 months
description: Quality of Life will be measured using an aggregate of the Pediatric Quality of Life Inventory (PedsQL) Core 4.0 and Diabetes 3.2 modules.
measure: Cortisol
time frame: 1 and 3 months
description: Morning and evening Cortisol levels will be measured using a saliva collection device
arm group label: Sleep Extension
arm group type: Experimental
description: All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer.
arm group label: Routine
arm group type: Sham Comparator
description: All youth in this condition are asked to follow the routine that their clinical team has established.
intervention type: Behavioral
intervention name: Sleep Extension
description: All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer
arm group label: Sleep Extension
intervention type: Behavioral
intervention name: Routine
description: All youth in this condition are asked to follow the routines set by their clinical care team.
arm group label: Routine
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Michelle M Perfect, PhD
role: Principal Investigator
affiliation: UA College of Education
last name: Michelle M Perfect, PhD
phone: 5206261128
email: mperfect@email.arizona.edu
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: Upon request.