<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/NCT03793673</url>
  </required_header>
  <id_info>
    <org_study_id>CHLA-18-00488</org_study_id>
    <nct_id>NCT03793673</nct_id>
  </id_info>
  <brief_title>CoYoT1 to California</brief_title>
  <acronym>CTC</acronym>
  <official_title>CoYoT1 to California - Telemedicine to Engage Young Adults With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rutgers University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Los Angeles</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>
      CoYoT1 to California (CTC) was initiated to develop a patient-centered, home telehealth care&#xD;
      model for young adults (YA) ages 16-25 with T1D. It is a 2x2 factorial design, 15-month&#xD;
      intervention. Eighty participants will be randomized to Standard Care or CoYoT1 Care, which&#xD;
      is delivered by telehealth or in-person. CoYoT1 Care is a patient-centered care model that&#xD;
      consists of three major components: shared decision making (patient and provider agree upon&#xD;
      priorities for the medical visit), autonomy and supportive care (provider training in&#xD;
      communication strategies such as motivational interviewing), and goal setting and action&#xD;
      planning (provider training to coach YA in setting SMART goals, developing action plans, and&#xD;
      designing follow up plans). Additionally, didactic expert-led sessions (Standard Care) or&#xD;
      peer-led, YA-driven group sessions (CoYoT1 Care) are included. At the end of the study, a&#xD;
      focus group will be completed to assist in determining which features YA felt were critical&#xD;
      to their success from the telehealth intervention, group components, and provider behaviors.&#xD;
&#xD;
      ***COVID-19 Update: Due to current hospital and clinical policy adaptation for COVID-19, all&#xD;
      participants who were randomized into in-person appointments will now receive care via&#xD;
      Telehealth. Telehealth has been implemented hospital-wide and will be the temporary delivery&#xD;
      of care method during this pandemic. Participants have been notified of this change and given&#xD;
      instruction on how to participate in a Telehealth appointment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Standard Care - Standard (in -person) appointments&#xD;
&#xD;
             -  Usual medical appointments.&#xD;
&#xD;
             -  Opportunity to participate in available community and CHLA based educational and&#xD;
                support events.&#xD;
&#xD;
             -  Complete online assessments/questionnaires.&#xD;
&#xD;
             -  Invitation to a 2 hour audio-recorded discussion at the end of the study&#xD;
&#xD;
                  -  COVID-19 Update: Current clinic appointments consist of telehealth&#xD;
                     appointments only. Any additional community and CHLA based educational and&#xD;
                     support events will be following COVID-19 guidelines.&#xD;
&#xD;
        2. Standard Care - Telehealth appointments&#xD;
&#xD;
             -  Telehealth - with provider and/or team. Online video appointments every 3 months,&#xD;
                upload diabetes data to Tidepool, and do routine blood work at a facility near you&#xD;
&#xD;
             -  Opportunity to participate in available community and CHLA based educational and&#xD;
                support events&#xD;
&#xD;
             -  Complete online assessments/questionnaires&#xD;
&#xD;
             -  Invitation to a 2 hour audio-recorded discussion at the end of the study&#xD;
&#xD;
                  -  COVID-19 Update: Any community and CHLA based educational and support events&#xD;
                     will be following COVID-19 guidelines. If in-person routine bloodwork is not&#xD;
                     feasible, HbA1c kits will be provided to participants.&#xD;
&#xD;
        3. CoYoT1 Care - Standard Appointment&#xD;
&#xD;
             -  In-person - medical appointments with provider and/or team&#xD;
&#xD;
             -  Opportunity to participate in 30-60 minute online peer-led diabetes group&#xD;
                discussions&#xD;
&#xD;
             -  Complete online assessments/questionnaires&#xD;
&#xD;
             -  Invitation to a 2 hour audio-recorded discussion at the end of the study&#xD;
&#xD;
                  -  COVID-19 Update: Current clinic appointments consist of telehealth&#xD;
                     appointments only.&#xD;
&#xD;
        4. CoYoT1 Care - Telehealth appointments&#xD;
&#xD;
             -  Telehealth - with provider and/or team. Online video appointment every 3 months,&#xD;
                upload your diabetes data to Tidepool, and do routine blood work at a facility near&#xD;
                you&#xD;
&#xD;
             -  Opportunity to participate in 30-60 minute online peer-led diabetes group&#xD;
                discussions&#xD;
&#xD;
             -  Complete online assessments/questionnaires&#xD;
&#xD;
             -  Invitation to a 2 hour audio-recorded discussion at the end of the study&#xD;
&#xD;
                  -  COVID-19 Update: If in-person routine bloodwork is not feasible, HbA1c kits&#xD;
                     will be provided to participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 28, 2022</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>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with completed appointments in telemedicine cohort</measure>
    <time_frame>12 months</time_frame>
    <description>Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with completed appointments in telemedicine cohort</measure>
    <time_frame>12 months</time_frame>
    <description>Patient online attendance as assessed using an online patient experience questionnaire - Polar Questions; Yes or no response questions related to patient's online appointment (i.e., did you have an online appointment? Did you attend your appointment?)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with completed medical appointments in standard care cohort</measure>
    <time_frame>12 months</time_frame>
    <description>In-person patient appointment attendance assessed using an online patient experience questionnaire. Polar questions; Yes or No response questions related to patient's in-person appointment (i.e., did you have an in-person appointment? Did you attend your in-person appointment?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>: Likert scale &quot;Very dissatisfied&quot; is 1, &quot;Dissatisfied&quot; is 2, &quot;Neutral&quot; is 3, &quot;Satisfied&quot; is 4, and &quot;Very Satisfied&quot; is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Experience as assessed using the CAHPS survey</measure>
    <time_frame>12 months</time_frame>
    <description>Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire</measure>
    <time_frame>[Time Frame: For each visit (until the end of study) - 12 months]</time_frame>
    <description>Likert scale; &quot;Strongly disagree&quot; is 1, &quot;Somewhat disagree&quot; is 2, &quot;Neutral&quot; is 3, &quot;Somewhat Agree&quot; is 4, and &quot;Strongly Agree&quot; is 5. Scores are summed and the average is taken; higher scores is more self-efficacy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Satisfaction as assessed using the Satisfaction Provider survey</measure>
    <time_frame>12 months</time_frame>
    <description>Telehealth Utilization satisfaction as assessed using a telehealth satisfaction questionnaire. Likert scale; range 1-5, low values indicate low satisfaction and higher values indicate high satisfaction. Polar: Yes or No response questions, &quot;Would you use telehealth again?&quot; Open ended; patient comments about experience.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Experience</measure>
    <time_frame>12 months</time_frame>
    <description>Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Social Determinants of Health Tool</measure>
    <time_frame>At 0 (baseline)</time_frame>
    <description>Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, &quot;did you worry that your food would run out before you got money to buy more?&quot; &quot;have you or your family ever been unable to go to the doctor because of distance or transportation?&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Costs to Patients</measure>
    <time_frame>12 months</time_frame>
    <description>Transportation cost to patient as assessed using a Transportation Questionnaire. Multiple choice questions about mode of transportation used to get to appointment, &quot;driving own vehicle,&quot; &quot;riding public transit,&quot; &quot;ride with family member or friend.&quot; Open ended to assess cost of parking, bus fare.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs to Patients</measure>
    <time_frame>12 months</time_frame>
    <description>Number of patients with need for a technology device (cellphone) as assessed using a Device Assessment questionnaire. Polar; Yes or No question about access to personal device patient has for online appointment, &quot;do you have a personal device to access the internet?.&quot; Multiple choice questions about device; &quot;Mobile phone,&quot; &quot;Laptop,&quot; &quot;Tablet,&quot; &quot;Ethernet,&quot; &quot;Wi-Fi.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs to Patients</measure>
    <time_frame>12 months</time_frame>
    <description>Diabetes visit expenses questions - polar questions, multiple choice, and open-ended</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Instituition</measure>
    <time_frame>12 months</time_frame>
    <description>Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, &quot;have you had to be admitted to the hospital?&quot; Open-ended question about number of time health services were used, &quot;how many times were you admitted to the hospital for reasons related to diabetes?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Instituition</measure>
    <time_frame>12 months</time_frame>
    <description>Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to online appointment. &quot;Did you attend your online appointment?&quot; &quot;What types of providers did you see?&quot; Open-ended questions asking about time, &quot;how long did it take?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Instituition</measure>
    <time_frame>12 months</time_frame>
    <description>Cost to Institution as assessed using the In-Person Appointment questionnaire. Polar; Yes or No questionnaire about appointment attendance; &quot;did you attend an in-person appointment?&quot; &quot;How long was your in-person appointment?&quot; Open-ended questions about time, &quot;how long did it take?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Instituition</measure>
    <time_frame>12 months</time_frame>
    <description>Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Instituition</measure>
    <time_frame>12 months</time_frame>
    <description>Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, &quot;Doctor,&quot; &quot;Nurse Practitioner,&quot; &quot;Social Worker.&quot; Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, &quot;camera and mic,&quot; &quot;loading Webex platform.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Control at Baseline</measure>
    <time_frame>HbA1c for the last 12 months</time_frame>
    <description>Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Control Progression</measure>
    <time_frame>For each visit (until the end of study) - 12 months</time_frame>
    <description>Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Payor</measure>
    <time_frame>12 months (monthly)</time_frame>
    <description>Cost to Payor as assessed using Health Care Utilization Online questionnaire. Polar; Yes and No questions about patient use of health services, &quot;In the last 3 months, has 911 been called because of your diabetes?&quot; Open-ended questions about rate of health service use, &quot;how many times was 911 called?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Payor</measure>
    <time_frame>12 months</time_frame>
    <description>Cost to payor as assessed using Clinic Cost, Preparation, and Delivery questionnaire for Providers or Staff. Open ended questions about length of training and technology used, along with any comments about appointment delivery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Payor</measure>
    <time_frame>12 months</time_frame>
    <description>Cost to payor as assessed using the Team Costs of Provider or Staff questionnaire. Open ended question asking about length of training and training required on &quot;billing process,&quot; &quot;data collection process,&quot; &quot;camera and mic.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost to Payor as as assessed using the Team Costs- YA</measure>
    <time_frame>12 months</time_frame>
    <description>Multiple Choice and fill-in. Questions about time spent training young adults and training required on &quot;Agenda setting&quot;, &quot;Camera and Mic&quot;, &quot;Loading Webex platform&quot;.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire.</measure>
    <time_frame>At 0 (baseline) and 12 months (after visit 4)</time_frame>
    <description>Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D)</measure>
    <time_frame>At 0 (baseline) and 12 months (after visit 4)</time_frame>
    <description>&quot;Rarely or none of the time (less than 1 day)&quot; is 0, &quot;Some or a little of the time (1-2 days)&quot; is 1, &quot;Occasionally or a moderate amount of time&quot; is 2, &quot;Most or all of the time (5-7 days)&quot; is 3. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure</measure>
    <time_frame>At 0 (baseline) and 12 months (after visit 4)</time_frame>
    <description>Likert scale; &quot;Excellent&quot; is 1, &quot;Very good&quot; is 2, &quot;Good&quot; is 3, &quot;Fair&quot; is 4, and &quot;Poor&quot; is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS)</measure>
    <time_frame>At 0 (baseline) and 12 months (after visit 4)</time_frame>
    <description>Likert scale; &quot;Not a problem&quot; is 1, &quot;A slight problem&quot; is 2, &quot;A moderate problem&quot; is 3, &quot;Somewhat serious problem&quot; is 4, &quot;A Serious Problem&quot; is 5, and &quot;A very serious problem&quot; is 6. There are 4 subscales that address the dimensions of distress and to score, the appropriate item(s) are summed and divided by appropriate number. A mean item score of 3 or higher is considered moderate distress.&#xD;
burden, regimen distress, interpersonal distress and physician distress; likert scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Diabetes-Related Psychosocial Self-Efficacy</measure>
    <time_frame>At 0 (baseline) and 12 months (after visit 4)</time_frame>
    <description>Diabetes-related psychosocial self-efficacy as assessed using the Diabetes Empowerment Scale Short Form (DES-SF); Likert scale; &quot;Strongly disagree&quot; is 1, &quot;Somewhat disagree&quot; is 2, &quot;Neutral&quot; is 3, &quot;Somewhat Agree&quot; is 4, and &quot;Strongly Agree&quot; is 5. Scores are summed and the average is taken; higher scores is more self-efficacy</description>
  </other_outcome>
  <other_outcome>
    <measure>Self Care - Realted to Diabetes as assessed by Self-Care questionnaire</measure>
    <time_frame>[At 0 (baseline) and each visit (until the end of study) - 12 months]</time_frame>
    <description>Multiple Choice. Questions about diabetes related self care, &quot;How many hours per day do you currently devote to managing your glucose levels?&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>CoYoT1 Care - Tools Questions</measure>
    <time_frame>[At 12 months or Visit 4]</time_frame>
    <description>Record keeping for tools to give to patients in transition to non-study visits (ie: Shared Decision Making tool and Tidepool)</description>
  </other_outcome>
  <other_outcome>
    <measure>Standard Care - Tools Questions</measure>
    <time_frame>[At 12 months or Visit 4]</time_frame>
    <description>Record keeping for tools to give to patients in transition to non-study visits (ie:Tidepool)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Standard Care: Standard appointments</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual in-person medical appointments. See previous detailed description.&#xD;
COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care: Telehealth appointments</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Telehealth - with provider and/or team. See previous detailed description.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CoYoT1 Care: Standard Appointment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In-person - medical appointments with provider and/or team. See previous detailed description.&#xD;
COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CoYoT1 Care: Telehealth appointments</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Telehealth - with provider and/or team. See previous detailed description.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CoYoT1 Care</intervention_name>
    <description>Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.</description>
    <arm_group_label>CoYoT1 Care: Standard Appointment</arm_group_label>
    <arm_group_label>CoYoT1 Care: Telehealth appointments</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care.&#xD;
NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments.</description>
    <arm_group_label>Standard Care: Standard appointments</arm_group_label>
    <arm_group_label>Standard Care: Telehealth appointments</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient aged 16-25 years of age on their date of recruitment who has had T1D for&#xD;
             at least 6 months.&#xD;
&#xD;
          -  Receiving or pending care at CHLA&#xD;
&#xD;
          -  Has California Children's Services (CCS), self-pay, and/or private insurance&#xD;
             (excluding United and Healthnet insurance)&#xD;
&#xD;
          -  Does not plan to transfer out of CHLA within the next year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient with severe behavioral or developmental disabilities&#xD;
&#xD;
          -  Severe psychological diagnoses that would make group participation difficult&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Non-English speaking patients and families&#xD;
&#xD;
          -  Has United or Healthnet private insurance&#xD;
&#xD;
          -  Literacy or cognitive issues that preclude the use of the Internet&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer K Raymond, MD, MCR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Guljas R, Ahmed A, Chang K, Whitlock A. Impact of telemedicine in managing type 1 diabetes among school-age children and adolescents: an integrative review. J Pediatr Nurs. 2014 May-Jun;29(3):198-204. doi: 10.1016/j.pedn.2013.10.013. Epub 2013 Oct 31.</citation>
    <PMID>24269308</PMID>
  </reference>
  <reference>
    <citation>Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.</citation>
    <PMID>23340893</PMID>
  </reference>
  <reference>
    <citation>Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.</citation>
    <PMID>25998289</PMID>
  </reference>
  <reference>
    <citation>Park MJ, Scott JT, Adams SH, Brindis CD, Irwin CE Jr. Adolescent and young adult health in the United States in the past decade: little improvement and young adults remain worse off than adolescents. J Adolesc Health. 2014 Jul;55(1):3-16. doi: 10.1016/j.jadohealth.2014.04.003. Epub 2014 May 10.</citation>
    <PMID>24815958</PMID>
  </reference>
  <reference>
    <citation>Monaghan M, Helgeson V, Wiebe D. Type 1 diabetes in young adulthood. Curr Diabetes Rev. 2015;11(4):239-50. doi: 10.2174/1573399811666150421114957.</citation>
    <PMID>25901502</PMID>
  </reference>
  <reference>
    <citation>American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.</citation>
    <PMID>23468086</PMID>
  </reference>
  <reference>
    <citation>Li R, Barker LE, Shrestha S, Zhang P, Duru OK, Pearson-Clarke T, Gregg EW. Changes over time in high out-of-pocket health care burden in U.S. adults with diabetes, 2001-2011. Diabetes Care. 2014 Jun;37(6):1629-35. doi: 10.2337/dc13-1997. Epub 2014 Mar 25.</citation>
    <PMID>24667459</PMID>
  </reference>
  <reference>
    <citation>Naranjo D, Schwartz DD, Delamater AM. Diabetes in ethnically diverse youth: disparate burden and intervention approaches. Curr Diabetes Rev. 2015;11(4):251-60. doi: 10.2174/1573399811666150421115846.</citation>
    <PMID>25901501</PMID>
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    <PMID>24582008</PMID>
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  <reference>
    <citation>Lado JJ, Lipman TH. Racial and Ethnic Disparities in the Incidence, Treatment, and Outcomes of Youth with Type 1 Diabetes. Endocrinol Metab Clin North Am. 2016 Jun;45(2):453-61. doi: 10.1016/j.ecl.2016.01.002. Epub 2016 Apr 7.</citation>
    <PMID>27241975</PMID>
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    <citation>Peters A, Laffel L; American Diabetes Association Transitions Working Group. Diabetes care for emerging adults: recommendations for transition from pediatric to adult diabetes care systems: a position statement of the American Diabetes Association, with representation by the American College of Osteopathic Family Physicians, the American Academy of Pediatrics, the American Association of Clinical Endocrinologists, the American Osteopathic Association, the Centers for Disease Control and Prevention, Children with Diabetes, The Endocrine Society, the International Society for Pediatric and Adolescent Diabetes, Juvenile Diabetes Research Foundation International, the National Diabetes Education Program, and the Pediatric Endocrine Society (formerly Lawson Wilkins Pediatric Endocrine Society). Diabetes Care. 2011 Nov;34(11):2477-85. doi: 10.2337/dc11-1723. No abstract available. Erratum In: Diabetes Care. 2012 Jan;35(1):191.</citation>
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    <citation>Orals. Diabetes. 2013 Jul;62(Supplement_1):A1-A98. doi: 10.2337/db13-1-387. No abstract available.</citation>
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    <citation>Garvey KC, Beste MG, Luff D, Atakov-Castillo A, Wolpert HA, Ritholz MD. Experiences of health care transition voiced by young adults with type 1 diabetes: a qualitative study. Adolesc Health Med Ther. 2014 Oct 20;5:191-8. doi: 10.2147/AHMT.S67943. eCollection 2014.</citation>
    <PMID>25349485</PMID>
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    <citation>Dougherty JP, Lipman TH, Hyams S, Montgomery KA. Telemedicine for adolescents with type 1 diabetes. West J Nurs Res. 2014 Oct;36(9):1199-221. doi: 10.1177/0193945914528387. Epub 2014 Apr 1.</citation>
    <PMID>24695401</PMID>
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    <citation>Raymond JK. Models of Care for Adolescents and Young Adults with Type 1 Diabetes in Transition: Shared Medical Appointments and Telemedicine. Pediatr Ann. 2017 May 1;46(5):e193-e197. doi: 10.3928/19382359-20170425-01.</citation>
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    <PMID>20167185</PMID>
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    <citation>Boogerd EA, Noordam C, Kremer JA, Prins JB, Verhaak CM. Teaming up: feasibility of an online treatment environment for adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Aug;15(5):394-402. doi: 10.1111/pedi.12103. Epub 2013 Dec 18.</citation>
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    <citation>Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.</citation>
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    <citation>Heyworth L, Rozenblum R, Burgess JF Jr, Baker E, Meterko M, Prescott D, Neuwirth Z, Simon SR. Influence of shared medical appointments on patient satisfaction: a retrospective 3-year study. Ann Fam Med. 2014 Jul;12(4):324-30. doi: 10.1370/afm.1660.</citation>
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    <citation>Raymond JK, Berget CL, Driscoll KA, Ketchum K, Cain C, Fred Thomas JF. CoYoT1 Clinic: Innovative Telemedicine Care Model for Young Adults with Type 1 Diabetes. Diabetes Technol Ther. 2016 Jun;18(6):385-90. doi: 10.1089/dia.2015.0425. Epub 2016 May 19.</citation>
    <PMID>27196443</PMID>
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    <citation>Raymond JK, Shea JJ, Berget C, Cain C, Fay-Itzkowitz E, Gilmer L, Hoops S, Owen D, Shepard D, Spiegel G, Klingensmith G. A novel approach to adolescents with type 1 diabetes: the team clinic model. Diabetes Spectr. 2015 Jan;28(1):68-71. doi: 10.2337/diaspect.28.1.68. No abstract available.</citation>
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  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Los Angeles</investigator_affiliation>
    <investigator_full_name>jennifer raymond</investigator_full_name>
    <investigator_title>MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee</investigator_title>
  </responsible_party>
  <keyword>Adolescents and Young Adults(AYA)</keyword>
  <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/NCT03793673
org study id: CHLA-18-00488
nct id: NCT03793673
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
CoYoT1 to California (CTC) was initiated to develop a patient-centered, home telehealth care
      model for young adults (YA) ages 16-25 with T1D. It is a 2x2 factorial design, 15-month
      intervention. Eighty participants will be randomized to Standard Care or CoYoT1 Care, which
      is delivered by telehealth or in-person. CoYoT1 Care is a patient-centered care model that
      consists of three major components: shared decision making (patient and provider agree upon
      priorities for the medical visit), autonomy and supportive care (provider training in
      communication strategies such as motivational interviewing), and goal setting and action
      planning (provider training to coach YA in setting SMART goals, developing action plans, and
      designing follow up plans). Additionally, didactic expert-led sessions (Standard Care) or
      peer-led, YA-driven group sessions (CoYoT1 Care) are included. At the end of the study, a
      focus group will be completed to assist in determining which features YA felt were critical
      to their success from the telehealth intervention, group components, and provider behaviors.

      ***COVID-19 Update: Due to current hospital and clinical policy adaptation for COVID-19, all
      participants who were randomized into in-person appointments will now receive care via
      Telehealth. Telehealth has been implemented hospital-wide and will be the temporary delivery
      of care method during this pandemic. Participants have been notified of this change and given
      instruction on how to participate in a Telehealth appointment.
1. Standard Care - Standard (in -person) appointments

             -  Usual medical appointments.

             -  Opportunity to participate in available community and CHLA based educational and
                support events.

             -  Complete online assessments/questionnaires.

             -  Invitation to a 2 hour audio-recorded discussion at the end of the study

                  -  COVID-19 Update: Current clinic appointments consist of telehealth
                     appointments only. Any additional community and CHLA based educational and
                     support events will be following COVID-19 guidelines.

        2. Standard Care - Telehealth appointments

             -  Telehealth - with provider and/or team. Online video appointments every 3 months,
                upload diabetes data to Tidepool, and do routine blood work at a facility near you

             -  Opportunity to participate in available community and CHLA based educational and
                support events

             -  Complete online assessments/questionnaires

             -  Invitation to a 2 hour audio-recorded discussion at the end of the study

                  -  COVID-19 Update: Any community and CHLA based educational and support events
                     will be following COVID-19 guidelines. If in-person routine bloodwork is not
                     feasible, HbA1c kits will be provided to participants.

        3. CoYoT1 Care - Standard Appointment

             -  In-person - medical appointments with provider and/or team

             -  Opportunity to participate in 30-60 minute online peer-led diabetes group
                discussions

             -  Complete online assessments/questionnaires

             -  Invitation to a 2 hour audio-recorded discussion at the end of the study

                  -  COVID-19 Update: Current clinic appointments consist of telehealth
                     appointments only.

        4. CoYoT1 Care - Telehealth appointments

             -  Telehealth - with provider and/or team. Online video appointment every 3 months,
                upload your diabetes data to Tidepool, and do routine blood work at a facility near
                you

             -  Opportunity to participate in 30-60 minute online peer-led diabetes group
                discussions

             -  Complete online assessments/questionnaires

             -  Invitation to a 2 hour audio-recorded discussion at the end of the study

                  -  COVID-19 Update: If in-person routine bloodwork is not feasible, HbA1c kits
                     will be provided to participants.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: None (Open Label)
measure: Number of participants with completed appointments in telemedicine cohort
time frame: 12 months
description: Electronic Medical Record (EMR) Abstraction - number of appointments; multiple choice and open ended
measure: Number of participants with completed appointments in telemedicine cohort
time frame: 12 months
description: Patient online attendance as assessed using an online patient experience questionnaire - Polar Questions; Yes or no response questions related to patient's online appointment (i.e., did you have an online appointment? Did you attend your appointment?)
measure: Number of participants with completed medical appointments in standard care cohort
time frame: 12 months
description: In-person patient appointment attendance assessed using an online patient experience questionnaire. Polar questions; Yes or No response questions related to patient's in-person appointment (i.e., did you have an in-person appointment? Did you attend your in-person appointment?
measure: Patient and Provider Satisfaction as assessed using the Health Care Climate questionnaire
time frame: 12 months
description: : Likert scale "Very dissatisfied" is 1, "Dissatisfied" is 2, "Neutral" is 3, "Satisfied" is 4, and "Very Satisfied" is 5. Higher scores indicate more satisfaction, lower scores indicate low satisfaction
measure: Provider Experience as assessed using the CAHPS survey
time frame: 12 months
description: Cultural Competence Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10, low range indicates low trust and high values indicate trust.
measure: Patient Satisfaction with appointment type as assessed using the Updated CoYoT1 Satisfaction Questionnaire
time frame: [Time Frame: For each visit (until the end of study) - 12 months]
description: Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
measure: Provider Satisfaction as assessed using the Satisfaction Provider survey
time frame: 12 months
description: Telehealth Utilization satisfaction as assessed using a telehealth satisfaction questionnaire. Likert scale; range 1-5, low values indicate low satisfaction and higher values indicate high satisfaction. Polar: Yes or No response questions, "Would you use telehealth again?" Open ended; patient comments about experience.
measure: Patient Experience
time frame: 12 months
description: Patient Experience Measures Consumer Assessment of Healthcare Providers and Systems (CAHPS) - likert Scale; range 0-10; lower range represents low rating, higher ranges indicate higher rating
measure: Social Determinants of Health Tool
time frame: At 0 (baseline)
description: Social determinants of health as assessed using a social and environmental factors questionnaire. Polar; Yes or No questions about food insecurity and transportation, "did you worry that your food would run out before you got money to buy more?" "have you or your family ever been unable to go to the doctor because of distance or transportation?"
measure: Costs to Patients
time frame: 12 months
description: Transportation cost to patient as assessed using a Transportation Questionnaire. Multiple choice questions about mode of transportation used to get to appointment, "driving own vehicle," "riding public transit," "ride with family member or friend." Open ended to assess cost of parking, bus fare.
measure: Costs to Patients
time frame: 12 months
description: Number of patients with need for a technology device (cellphone) as assessed using a Device Assessment questionnaire. Polar; Yes or No question about access to personal device patient has for online appointment, "do you have a personal device to access the internet?." Multiple choice questions about device; "Mobile phone," "Laptop," "Tablet," "Ethernet," "Wi-Fi."
measure: Costs to Patients
time frame: 12 months
description: Diabetes visit expenses questions - polar questions, multiple choice, and open-ended
measure: Cost to Instituition
time frame: 12 months
description: Cost to Institution as assessed by Patient Health Utilization questionnaire. Polar; Yes or No questions about health service usage in the last three months, "have you had to be admitted to the hospital?" Open-ended question about number of time health services were used, "how many times were you admitted to the hospital for reasons related to diabetes?"
measure: Cost to Instituition
time frame: 12 months
description: Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to online appointment. "Did you attend your online appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"
measure: Cost to Instituition
time frame: 12 months
description: Cost to Institution as assessed using the In-Person Appointment questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"
measure: Cost to Instituition
time frame: 12 months
description: Cost to Institution as assessed using the Clinic Cost, Preparation, and Delivery for Providers and Staff questionnaire. Multiple choice questions about person (Doctor, Nurse and Social Worker) and appointment type provided to patient
measure: Cost to Instituition
time frame: 12 months
description: Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained, "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for telehealth appointment; training on, "camera and mic," "loading Webex platform."
measure: Glycemic Control at Baseline
time frame: HbA1c for the last 12 months
description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
measure: Glycemic Control Progression
time frame: For each visit (until the end of study) - 12 months
description: Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %
measure: Cost to Payor
time frame: 12 months (monthly)
description: Cost to Payor as assessed using Health Care Utilization Online questionnaire. Polar; Yes and No questions about patient use of health services, "In the last 3 months, has 911 been called because of your diabetes?" Open-ended questions about rate of health service use, "how many times was 911 called?"
measure: Cost to Payor
time frame: 12 months
description: Cost to payor as assessed using Clinic Cost, Preparation, and Delivery questionnaire for Providers or Staff. Open ended questions about length of training and technology used, along with any comments about appointment delivery.
measure: Cost to Payor
time frame: 12 months
description: Cost to payor as assessed using the Team Costs of Provider or Staff questionnaire. Open ended question asking about length of training and training required on "billing process," "data collection process," "camera and mic."
measure: Cost to Payor as as assessed using the Team Costs- YA
time frame: 12 months
description: Multiple Choice and fill-in. Questions about time spent training young adults and training required on "Agenda setting", "Camera and Mic", "Loading Webex platform".
measure: Self-care, mobility, and anxiety and depression as assessed using the EuroQOL five dimensions five levels questionnaire (EQ-5D-5L) questionnaire.
time frame: At 0 (baseline) and 12 months (after visit 4)
description: Likert scale; used to measure respondents' endorsement of particular statements. Descriptive system top answer is 1 and last answer is 5. Missing items will be coded as 9. Online software used to score.
measure: Depressive symptoms assessed using the Center of Epidemiologic Studies Scale (CES-D)
time frame: At 0 (baseline) and 12 months (after visit 4)
description: "Rarely or none of the time (less than 1 day)" is 0, "Some or a little of the time (1-2 days)" is 1, "Occasionally or a moderate amount of time" is 2, "Most or all of the time (5-7 days)" is 3. The scoring of positive items is reversed. Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
measure: Patient health-related quality of life as assessed using the Your Health and Well-being Short-Form 12 item Version 2 (SF12V2) measure
time frame: At 0 (baseline) and 12 months (after visit 4)
description: Likert scale; "Excellent" is 1, "Very good" is 2, "Good" is 3, "Fair" is 4, and "Poor" is 5. An algorithm is used to generate the physical and mental health composite scores for comparison (a confirmatory factor analyses).Items are scored so that a higher score indicates a better health state.
measure: Dimensions of distress (e.g., emotional burden, regimen distress, interpersonal distress and physician distress) as assessed using the Diabetes Distress Scale (DDS)
time frame: At 0 (baseline) and 12 months (after visit 4)
description: Likert scale; "Not a problem" is 1, "A slight problem" is 2, "A moderate problem" is 3, "Somewhat serious problem" is 4, "A Serious Problem" is 5, and "A very serious problem" is 6. There are 4 subscales that address the dimensions of distress and to score, the appropriate item(s) are summed and divided by appropriate number. A mean item score of 3 or higher is considered moderate distress.
burden, regimen distress, interpersonal distress and physician distress; likert scale
measure: Assessment of Diabetes-Related Psychosocial Self-Efficacy
time frame: At 0 (baseline) and 12 months (after visit 4)
description: Diabetes-related psychosocial self-efficacy as assessed using the Diabetes Empowerment Scale Short Form (DES-SF); Likert scale; "Strongly disagree" is 1, "Somewhat disagree" is 2, "Neutral" is 3, "Somewhat Agree" is 4, and "Strongly Agree" is 5. Scores are summed and the average is taken; higher scores is more self-efficacy
measure: Self Care - Realted to Diabetes as assessed by Self-Care questionnaire
time frame: [At 0 (baseline) and each visit (until the end of study) - 12 months]
description: Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"
measure: CoYoT1 Care - Tools Questions
time frame: [At 12 months or Visit 4]
description: Record keeping for tools to give to patients in transition to non-study visits (ie: Shared Decision Making tool and Tidepool)
measure: Standard Care - Tools Questions
time frame: [At 12 months or Visit 4]
description: Record keeping for tools to give to patients in transition to non-study visits (ie:Tidepool)
arm group label: Standard Care: Standard appointments
arm group type: Other
description: Usual in-person medical appointments. See previous detailed description.
COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines.
arm group label: Standard Care: Telehealth appointments
arm group type: Other
description: Telehealth - with provider and/or team. See previous detailed description.
arm group label: CoYoT1 Care: Standard Appointment
arm group type: Other
description: In-person - medical appointments with provider and/or team. See previous detailed description.
COVID-19 Update: Current clinic appointments consist of telehealth appointments only. Any additional community and CHLA based educational and support events will be following COVID-19 guidelines.
arm group label: CoYoT1 Care: Telehealth appointments
arm group type: Other
description: Telehealth - with provider and/or team. See previous detailed description.
intervention type: Behavioral
intervention name: CoYoT1 Care
description: Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.
arm group label: CoYoT1 Care: Standard Appointment
arm group label: CoYoT1 Care: Telehealth appointments
intervention type: Other
intervention name: Standard Care
description: Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care.
NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments.
arm group label: Standard Care: Standard appointments
arm group label: Standard Care: Telehealth appointments
criteria: 
gender: All
minimum age: 16 Years
maximum age: 25 Years
healthy volunteers: No
last name: Jennifer K Raymond, MD, MCR
role: Principal Investigator
affiliation: Children's Hospital Los Angeles
facility: 
country: United States
citation: Guljas R, Ahmed A, Chang K, Whitlock A. Impact of telemedicine in managing type 1 diabetes among school-age children and adolescents: an integrative review. J Pediatr Nurs. 2014 May-Jun;29(3):198-204. doi: 10.1016/j.pedn.2013.10.013. Epub 2013 Oct 31.
PMID: 24269308
citation: Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, Quinn M, Tamborlane WV, Woerner SE; T1D Exchange Clinic Network. Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care. 2013 Jul;36(7):2035-7. doi: 10.2337/dc12-1959. Epub 2013 Jan 22.
PMID: 23340893
citation: Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, Maahs DM, Tamborlane WV; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care. 2015 Jun;38(6):971-8. doi: 10.2337/dc15-0078.
PMID: 25998289
citation: Park MJ, Scott JT, Adams SH, Brindis CD, Irwin CE Jr. Adolescent and young adult health in the United States in the past decade: little improvement and young adults remain worse off than adolescents. J Adolesc Health. 2014 Jul;55(1):3-16. doi: 10.1016/j.jadohealth.2014.04.003. Epub 2014 May 10.
PMID: 24815958
citation: Monaghan M, Helgeson V, Wiebe D. Type 1 diabetes in young adulthood. Curr Diabetes Rev. 2015;11(4):239-50. doi: 10.2174/1573399811666150421114957.
PMID: 25901502
citation: American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
PMID: 23468086
citation: Li R, Barker LE, Shrestha S, Zhang P, Duru OK, Pearson-Clarke T, Gregg EW. Changes over time in high out-of-pocket health care burden in U.S. adults with diabetes, 2001-2011. Diabetes Care. 2014 Jun;37(6):1629-35. doi: 10.2337/dc13-1997. Epub 2014 Mar 25.
PMID: 24667459
citation: Naranjo D, Schwartz DD, Delamater AM. Diabetes in ethnically diverse youth: disparate burden and intervention approaches. Curr Diabetes Rev. 2015;11(4):251-60. doi: 10.2174/1573399811666150421115846.
PMID: 25901501
citation: Valenzuela JM, Seid M, Waitzfelder B, Anderson AM, Beavers DP, Dabelea DM, Dolan LM, Imperatore G, Marcovina S, Reynolds K, Yi-Frazier J, Mayer-Davis EJ; SEARCH for Diabetes in Youth Study Group. Prevalence of and disparities in barriers to care experienced by youth with type 1 diabetes. J Pediatr. 2014 Jun;164(6):1369-75.e1. doi: 10.1016/j.jpeds.2014.01.035. Epub 2014 Feb 25.
PMID: 24582008
citation: Lado JJ, Lipman TH. Racial and Ethnic Disparities in the Incidence, Treatment, and Outcomes of Youth with Type 1 Diabetes. Endocrinol Metab Clin North Am. 2016 Jun;45(2):453-61. doi: 10.1016/j.ecl.2016.01.002. Epub 2016 Apr 7.
PMID: 27241975
citation: Peek ME, Cargill A, Huang ES. Diabetes health disparities: a systematic review of health care interventions. Med Care Res Rev. 2007 Oct;64(5 Suppl):101S-56S. doi: 10.1177/1077558707305409.
PMID: 17881626
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responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Los Angeles
investigator full name: jennifer raymond
investigator title: MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No