<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/NCT03832790</url>
  </required_header>
  <id_info>
    <org_study_id>19-0186</org_study_id>
    <nct_id>NCT03832790</nct_id>
  </id_info>
  <brief_title>Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes</brief_title>
  <acronym>SunDIAL</acronym>
  <official_title>Sleep, Glycemic Control, and Insulin Resistance in Adolescents With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Juvenile Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Colorado Clinical &amp; Translational Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ludeman Family Center for Women's Health Research</agency>
      <agency_class>Other</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>
      Despite advancements in care, most adolescents with T1D have higher BMI and significantly&#xD;
      higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2.&#xD;
      Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for&#xD;
      adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and&#xD;
      carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian&#xD;
      misalignment, which will allow for identification of new mechanisms that can be directly&#xD;
      translated into future intervention and prevention trials. The goal of the current study is&#xD;
      to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian&#xD;
      rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine&#xD;
      relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative&#xD;
      methodology will be used to identify barriers and facilitators to healthy sleep in&#xD;
      adolescents with T1D.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 15, 2023</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>HbA1c</measure>
    <time_frame>at 60 days</time_frame>
    <description>HbA1c</description>
  </primary_outcome>
  <primary_outcome>
    <measure>glycemic variability</measure>
    <time_frame>at 2 weeks</time_frame>
    <description>CGM glucose SD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>insulin sensitivity from hyperinsulinemic euglycemic clamp</measure>
    <time_frame>at study entry (baseline)</time_frame>
    <description>Si</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>at study entry (baseline)</time_frame>
    <description>body mass index</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Type1diabetes</condition>
  <condition>Adolescent Behavior</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>adolescents with type 1 diabetes</arm_group_label>
    <description>Adolescents ages 14-19 with type 1 diabetes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observation</intervention_name>
    <description>observation</description>
    <arm_group_label>adolescents with type 1 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescents with type 1 diabetes&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  attending high school&#xD;
&#xD;
          -  diagnosis of type 1 diabetes &gt;1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current diagnosis of a sleep disorder (e.g., insomnia, OSA) or abnormal scores on&#xD;
             sleep disorders screening measures&#xD;
&#xD;
          -  regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics,&#xD;
             melatonin, other sleep aids)&#xD;
&#xD;
          -  HbA1c ≥11 or &gt;14% for the previous 2+ measurements&#xD;
&#xD;
          -  IQ&lt;70 or severe mental illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus/Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angel Bernard</last_name>
      <phone>720-777-3491</phone>
      <email>angel.bernard@childrenscolorado.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Insulin Resistance</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/NCT03832790
org study id: 19-0186
nct id: NCT03832790
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite advancements in care, most adolescents with T1D have higher BMI and significantly
      higher HbA1c than recommended and are markedly IR, placing them at increased risk for CVD1,2.
      Thus, alternative approaches to improve and maintain glycemic control, IR, and BMI for
      adolescents with T1D are urgently needed. This proposal moves beyond the current insulin and
      carbohydrate counting-focused lifestyle change paradigm to focus on sleep and circadian
      misalignment, which will allow for identification of new mechanisms that can be directly
      translated into future intervention and prevention trials. The goal of the current study is
      to utilize multiple objective measures of sleep duration, timing (actigraphy), and circadian
      rhythm (melatonin) in adolescents with type 1 diabetes (T1D; N = 40) and examine
      relationships with glycemic control, IR, vascular health, and BMI. Further, qualitative
      methodology will be used to identify barriers and facilitators to healthy sleep in
      adolescents with T1D.
observational model: Cohort
time perspective: Prospective
measure: HbA1c
time frame: at 60 days
description: HbA1c
measure: glycemic variability
time frame: at 2 weeks
description: CGM glucose SD
measure: insulin sensitivity from hyperinsulinemic euglycemic clamp
time frame: at study entry (baseline)
description: Si
measure: BMI
time frame: at study entry (baseline)
description: body mass index
arm group label: adolescents with type 1 diabetes
description: Adolescents ages 14-19 with type 1 diabetes
intervention type: Other
intervention name: observation
description: observation
arm group label: adolescents with type 1 diabetes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 19 Years
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Resistance
sharing ipd: No