<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/NCT04506151</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0374</org_study_id>
    <secondary_id>1R01DK121726</secondary_id>
    <nct_id>NCT04506151</nct_id>
  </id_info>
  <brief_title>Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes</brief_title>
  <acronym>SOPT</acronym>
  <official_title>Sleep Optimization to Improve Glycemic Control in Adults With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</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 Illinois at Chicago</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with&#xD;
      negative health consequences including poor blood glucose control and greater diabetes&#xD;
      complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep&#xD;
      tracking technology, telephone coaching and informational content designed to improve sleep&#xD;
      and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to&#xD;
      reduced development of diabetes complications and improve quality of life for adults with&#xD;
      type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite improvements in treatment regimens and technology, less than 20% of adults with type&#xD;
      1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially&#xD;
      modifiable target for improving glycemic control. Diabetes distress, poor self-management&#xD;
      behaviors, and reduced quality of life (QoL) have also been linked to sleep variability and&#xD;
      insufficient sleep duration. The American Diabetes Association Standards of Medical Care in&#xD;
      Diabetes incorporated sleep as an important component of the medical evaluation in persons&#xD;
      with diabetes. However, no specific recommendation was given as to how to improve sleep. A&#xD;
      significant gap of knowledge exists regarding the effects of sleep optimization on glycemic&#xD;
      control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific&#xD;
      sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability,&#xD;
      sleep duration and glycemic control (A1C); other glycemic parameters (glycemic variability,&#xD;
      time in range), diabetes distress, self-management behavior, QoL, and other patient reported&#xD;
      outcomes in working-age adults with T1D and habitual increased sleep variability or short&#xD;
      sleep duration. To achieve these aims, a randomized controlled trial is planned in 120&#xD;
      working age adults (18 to 65 years) with T1D. Participants will be screened for habitual&#xD;
      sleep variability (&gt; 1 hour/week) or insufficient sleep duration (&lt; 6.5 hours per night).&#xD;
      Eligible subjects will be randomized to the Sleep-Opt group or healthy living attention&#xD;
      control group for twelve weeks. A one-week run-in period is planned, with baseline measures&#xD;
      of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic&#xD;
      measures: glycemic variability and time in range using continuous glucose monitoring), and&#xD;
      other secondary outcomes: diabetes distress, self-management behaviors, quality of life and&#xD;
      additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep&#xD;
      intervention that this study team developed that leverages the rapidly increasing public&#xD;
      interest in sleep tracking by consumers (+500% in 3 years). The behavioral intervention&#xD;
      employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone&#xD;
      application, and brief telephone counseling. The attention control group will participate in&#xD;
      a healthy living information program. At midpoint (Week 6) completion (Week 12) and&#xD;
      post-program (Week 24), baseline measures will be repeated to determine differences between&#xD;
      the two groups and sustainability of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 19, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2025</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>Sleep optimization intervention will be compared to an attention control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep variability</measure>
    <time_frame>Change from week 0, 6, 12, 24</time_frame>
    <description>Standard deviation total sleep time for one week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep duration</measure>
    <time_frame>Change from weeks 0. 6, 12, 24</time_frame>
    <description>total sleep time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>Change from week 0. 6, 12, 24</time_frame>
    <description>HbA1c blood test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diabetes distress</measure>
    <time_frame>Change from week 0. 6, 12, 24</time_frame>
    <description>T1D Diabetes Distress Scale score- higher numbers indicate greater distress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-management behavior</measure>
    <time_frame>Change from week. 6, 12, 24</time_frame>
    <description>Self-Management Questionnaire score- higher numbers indicate better self-management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Change from week 0. 6, 12, 24</time_frame>
    <description>Patient Reported Outcomes Measure (PROMIS) fatigue scale score - higher numbers greater fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>Change from week 0. 6, 12, 24</time_frame>
    <description>Center for Epidemiological Studies - Depressed Mood score - Higher numbers more depressive mood</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">144</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Sleep-Opt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12-week intervention that includes self-monitoring, goal setting, motivational enhancement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Living</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep-Opt</intervention_name>
    <description>12-week behavioral intervention</description>
    <arm_group_label>Sleep-Opt</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Living</intervention_name>
    <description>Healthy Living</description>
    <arm_group_label>Healthy Living</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults aged 18-65 years&#xD;
&#xD;
          -  clinical diagnosis of type 1 diabetes minimum of one year&#xD;
&#xD;
          -  reported habitual sleep variability (1 hour/week or more) or sleep duration less than&#xD;
             6.5 hrs/night during work- or weekdays (confirmed with actigraphy sleep watch)&#xD;
&#xD;
          -  a desire to improve sleep&#xD;
&#xD;
          -  own a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  insomnia symptoms&#xD;
&#xD;
          -  at high risk for obstructive sleep apnea&#xD;
&#xD;
          -  severe hypoglycemia episode in the past 6 months (e.g. loss of consciousness)&#xD;
&#xD;
          -  A1C greater than 10%&#xD;
&#xD;
          -  rotating shift or night shift work&#xD;
&#xD;
          -  use of sleep medications/aids&#xD;
&#xD;
          -  renal impairment (estimated glomerular filtration rate &lt; 45 ml/min)&#xD;
&#xD;
          -  significant current medical morbidities (such as heart failure, cirrhosis, chronic&#xD;
             obstructive pulmonary disease requiring oxygen, active treatment for cancer,&#xD;
             depression, history of stroke with neurological deficits&#xD;
&#xD;
          -  breast feeding, pregnant, or planning pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela Martyn-Nemeth, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pamela Martyn-Nemeth, PhD</last_name>
    <phone>312-996-7903</phone>
    <email>pmartyn@uic.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sirimon Reutrakul, MD</last_name>
    <email>sreutrak@uic.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Illinois Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pamela Martyn-Nemeth, PhD</last_name>
      <phone>312-996-7903</phone>
      <email>pmartyn@uic.edu</email>
    </contact>
    <contact_backup>
      <last_name>Sirimon Reutrakul, MD</last_name>
      <phone>3129966060</phone>
      <email>sreutrak@uic.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Pamela Martyn-Nemeth</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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>
  </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/NCT04506151
org study id: 2020-0374
secondary id: 1R01DK121726
nct id: NCT04506151
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Up to 40% of adults with type 1 diabetes have insufficient sleep which is associated with
      negative health consequences including poor blood glucose control and greater diabetes
      complications. In this study, a sleep intervention (Sleep-Opt) that uses wearable sleep
      tracking technology, telephone coaching and informational content designed to improve sleep
      and glycemic control in working-age adults with type 1 diabetes. Sleep-Opt could lead to
      reduced development of diabetes complications and improve quality of life for adults with
      type 1 diabetes.
Despite improvements in treatment regimens and technology, less than 20% of adults with type
      1 diabetes (T1D) achieve glycemic targets. Sleep is increasingly recognized as a potentially
      modifiable target for improving glycemic control. Diabetes distress, poor self-management
      behaviors, and reduced quality of life (QoL) have also been linked to sleep variability and
      insufficient sleep duration. The American Diabetes Association Standards of Medical Care in
      Diabetes incorporated sleep as an important component of the medical evaluation in persons
      with diabetes. However, no specific recommendation was given as to how to improve sleep. A
      significant gap of knowledge exists regarding the effects of sleep optimization on glycemic
      control in T1D. The purpose of this study is to determine the efficacy of a T1D-specific
      sleep optimization intervention (Sleep-Opt) on the primary outcomes of sleep variability,
      sleep duration and glycemic control (A1C); other glycemic parameters (glycemic variability,
      time in range), diabetes distress, self-management behavior, QoL, and other patient reported
      outcomes in working-age adults with T1D and habitual increased sleep variability or short
      sleep duration. To achieve these aims, a randomized controlled trial is planned in 120
      working age adults (18 to 65 years) with T1D. Participants will be screened for habitual
      sleep variability (> 1 hour/week) or insufficient sleep duration (< 6.5 hours per night).
      Eligible subjects will be randomized to the Sleep-Opt group or healthy living attention
      control group for twelve weeks. A one-week run-in period is planned, with baseline measures
      of sleep by actigraphy (sleep variability and duration), glycemia (A1C and related glycemic
      measures: glycemic variability and time in range using continuous glucose monitoring), and
      other secondary outcomes: diabetes distress, self-management behaviors, quality of life and
      additional patient-reported outcomes. Sleep-Opt is a technology-assisted behavioral sleep
      intervention that this study team developed that leverages the rapidly increasing public
      interest in sleep tracking by consumers (+500% in 3 years). The behavioral intervention
      employs four elements: a wearable sleep tracker, didactic content, an interactive smartphone
      application, and brief telephone counseling. The attention control group will participate in
      a healthy living information program. At midpoint (Week 6) completion (Week 12) and
      post-program (Week 24), baseline measures will be repeated to determine differences between
      the two groups and sustainability of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Sleep optimization intervention will be compared to an attention control group
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Sleep variability
time frame: Change from week 0, 6, 12, 24
description: Standard deviation total sleep time for one week
measure: Sleep duration
time frame: Change from weeks 0. 6, 12, 24
description: total sleep time
measure: Glycemic control
time frame: Change from week 0. 6, 12, 24
description: HbA1c blood test
measure: Diabetes distress
time frame: Change from week 0. 6, 12, 24
description: T1D Diabetes Distress Scale score- higher numbers indicate greater distress
measure: Self-management behavior
time frame: Change from week. 6, 12, 24
description: Self-Management Questionnaire score- higher numbers indicate better self-management
measure: Fatigue
time frame: Change from week 0. 6, 12, 24
description: Patient Reported Outcomes Measure (PROMIS) fatigue scale score - higher numbers greater fatigue
measure: Mood
time frame: Change from week 0. 6, 12, 24
description: Center for Epidemiological Studies - Depressed Mood score - Higher numbers more depressive mood
arm group label: Sleep-Opt
arm group type: Experimental
description: 12-week intervention that includes self-monitoring, goal setting, motivational enhancement.
arm group label: Healthy Living
arm group type: Active Comparator
description: 12-week intervention that includes weekly telephone contact, didactic content equal in time and attention to intervention group.
intervention type: Behavioral
intervention name: Sleep-Opt
description: 12-week behavioral intervention
arm group label: Sleep-Opt
intervention type: Behavioral
intervention name: Healthy Living
description: Healthy Living
arm group label: Healthy Living
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Pamela Martyn-Nemeth, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
last name: Pamela Martyn-Nemeth, PhD
phone: 312-996-7903
email: pmartyn@uic.edu
last name: Sirimon Reutrakul, MD
email: sreutrak@uic.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Pamela Martyn-Nemeth
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No