CClinicalTrials.gg
CompletedNCT04190368Updated Apr 4, 2025

Team Clinic: Virtual Expansion of an Innovative Multi-Disciplinary Care Model for Adolescents and Young Adults With Type 1 Diabetes

An interventional study of Team Clinic Care and Standard Care in Type 1 Diabetes, sponsored by Children's Hospital Los Angeles. Completed at 1 site in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-04.

Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
10 Years to 17 Years
Sex
All
01

Study summary

Team Clinic is a new care approach for middle and high school aged patients living with T1D and their families. This study is a 15-month randomized control trial (RCT) that consists of Virtual Team Clinic Care appointments (primarily telemedicine, and in-person as necessary) and Virtual Team Clinic group appointments with a multidisciplinary diabetes care team. Assignment into 1 of 4 intervention groups Team Clinic Care vs. Standard Care which consist of either Virtual Team Clinic Group or no group.

Groups:

  1. Standard Care - No Group
  2. Standard Care - Virtual Team Clinic Group
  3. Team Clinic Care - No Group
  4. Team Clinic Care - Virtual Team Clinic Group Virtual Team Clinic group sessions will be facilitated by clinical care team (e.g., Registered Dietician, Social Worker, Registered Nurse, etc.)

    • Patients and parents will attend their own online session
Read the detailed description

Team Clinic is an innovative approach to addressing patient developmental, psycho-social, and familial challenges; while also tackling the medical infrastructure and multi-disciplinary care challenges encountered by middle school and high school aged individuals with Type 1 Diabetes and their caregivers. This new approach consists of Team Clinic Care appointments (primarily telemedicine, and in-person as necessary). The study incorporates Virtual Team Clinic group/medical group appointments with a multidisciplinary diabetes care team of diabetes care providers. Each group will have a special theme (thematic group visits) and learning experience aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. Part of the goal of VTC is to spend less time in clinic while still receiving important diabetes education, support, and medical care.

02

Conditions studied

  • Type 1 Diabetes

Keywords

  • Adolescents
  • Young Adults
  • Group Medical Visits
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 79 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of type 1 diabetes > 6 month duration
  2. Grades 6th, 7th, and 8th ,9th, 10th, 11th, 12th at time of intervention
  3. Not currently participating in other group interventions
  4. English speaking

Exclusion criteria

Exclusions

  1. Severe behavioral or developmental disabilities in parent or child
  2. Severe psychological diagnoses in parent or child that would make group participation difficult
  3. Significant comorbid medical conditions that would make the patient non-eligible for group participation (e.g. cystic fibrosis, uncontrolled thyroid disease)
  4. Non-English speaking
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Other
    Team Clinic Care: No VTC Groups

    Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient and yearly team visit as needed • Providers will utilize a patient centered care approach to conducting appointments

    Other: Team Clinic Care

  • Other
    Team Clinic: Virtual Team Clinic Group

    Participants will be invited to participate in online/virtual thematic group sessions led by Team Clinic group facilitators (e.g., RD, SW, RN) aimed at improving glycemic control and treatment adherence, increasing social supports and diabetes care satisfaction, and aid in the transition from caregiver led treatment to self care. o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

    Other: Team Clinic Care

  • Other
    Standard Care: No VTC Groups

    Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services).

    Other: Standard Care

  • Other
    Standard Care: Virtual Team Clinic

    Appointments will continue as usually with provider (quarterly visits; 1 visit every 3 months), but will be referred for necessary care per usual methods (e.g., diabetes education or supportive services). o Patients and Family members attend their own online sessions: Energy Training, Proficiency Training, Resilience Training, Balance Training, Miscellaneous sessions - scheduled as needed

    Other: Standard Care

Interventions

  • OtherTeam Clinic Care

    Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient. Selected providers will be trained in the Team Clinic Care protocol for completing medical appointments. Team Clinic Care key components: (1) Shared decision making: Providers, AYA, parent/caregiver will mutually agree on priorities for each medical visit using a shared decision making tool (2) Autonomy supportive care: Providers will be trained in skills building, patient centered key elements, intervention bites, reviewing plans, designed to support AYA autonomy and intrinsic motivation. AYA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach AYA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate. (4) Fidelity Review and process for self-assessment

  • OtherStandard Care

    Participants attend quarterly visits (1 visit every 3 months) and see their diabetes care provider. They do not participate in Team Clinic group visits but if they need diabetes education or supportive services they will be referred for necessary care per usual methods.

06

What researchers measure

Primary outcomes

  1. Hemoglobin A1C at Baseline

    Lab Results: Electronic Medical Record Hemoglobin A1c (HbA1c) %

    Time frame: baseline to 12 months

  2. Hemoglobin A1C Progression

    HbA1c % At-Home Kit

    Time frame: At baseline (0), 3 months, 6 months, 9 months, 12 months

  3. Number of Team Clinic Care cohort participants attending appointments

    Attendance will be recorded for each Team Clinic visit

    Time frame: 12 months

  4. Number of Virtual Team Clinic Care cohort participants completing appointments

    Attendance will be recorded for each Virtual Team Clinic Visit

    Time frame: 12 months

  5. Number of Team Clinic Care cohort participants completing appointments

    Electronic Medical Record (EMR) Abstraction

    Time frame: 12 months

  6. Patient and Provider/Clinic Staff Satisfaction as assessed using the Health Care Climate questionnaire

    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

    Time frame: 12 months

  7. Patient and Provider/Staff Satisfaction

    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.

    Time frame: 12 months

  8. Patient Experience

    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

    Time frame: 12 months

  9. Social Determinants of Health Tool

    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?"

    Time frame: At 0 (baseline)

  10. Number of Standard Clinic cohort participants completing appointments

    Attendance will be recorded for each standard care visit

    Time frame: 12 months

  11. Number of Standard Care cohort participants completing appointments

    Electronic Medical Record (EMR) Abstraction

    Time frame: 12 months

Secondary outcomes

  1. Number of Team Clinic Care cohort participants with diabetic ketoacidosis

    Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR

    Time frame: 12 months

  2. Number of Standard Care cohort participants with diabetic ketoacidosis

    Diabetic ketoacidosis events both by self report (i.e., did you have any episodes of diabetic ketoacidosis in the past 3 months) and EMR

    Time frame: 12 months

  3. Number of Team Clinic cohort participants with severe hypoglycemia

    Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR

    Time frame: 12 months

  4. Number of Standard Care cohort participants with severe hypoglycemia

    Severe hypoglycemia events both by self report (i.e., did you have any episodes of severe hypoglycemia in the past 3 months) and EMR

    Time frame: 12 months

  5. Diabetes Family Conflict Scale

    Diabetes Family Conflict as assessed using the Diabetes Family Conflict Scale (DFCS) for parents and the DFCS for children. Each scale is a 20 item questionnaire using a Likert Scale (1 = Almost Never, 2 = Sometimes, 3 = Almost Always). Parent and Child questionnaires are combined with a possible score range from 40 to 120 with higher scores indicating more conflict.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  6. Problem Areas in Diabetes in Caregivers

    Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Caregivers (PAID-T). This instrument was designed to assess emotional distress related to caring for a teen with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  7. Problem Areas in Diabetes in Teens

    Problem Areas in Diabetes as assessed using the Problem Areas in Diabetes - Teens (PAID-T). This instrument was designed to assess emotional distress in teens with diabetes. It is a 26 item questionnaire using a 6 point Likert Scale format (1-2 = Not a problem, 3-4 = Moderate Problem, 5-6 = Serious Problem). The possible score range is from 26 to 156 with higher scores indicating increased distress.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  8. Patient - Practitioner Orientation Scale

    Patient - Practitioner Orientation Scale consists of 18 items and 2 subscales. It assesses provider beliefs on patient centeredness. 6-point Likert scale: "Strongly disagree," "Moderately Disagree," "Slightly Disagree," "Slightly Agree," "Moderately Agree," and "Strongly Agree." PPOs score is computed by taking the mean of the 18 items with a minimum score being "1" and maximum being "6." Higher scores present more patient-centered attitudes.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  9. Cost to Instituition

    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?"

    Time frame: 12 months

  10. Cost to Institution - Standard care

    Cost to Institution as assessed using the In Person questionnaire. Polar; Yes or No questionnaire about appointment attendance; "did you attend an in-person, standard care appointment?" "How long was your in-person appointment?" Open-ended questions about time, "how long did it take?"

    Time frame: 12 months

  11. Cost to Institution - Team Clinic

    Cost to Institution as assessed using the Online Appointment questionnaire. Polar; Yes or No questions about attendance to in person, Team Clinic care appointment. "Did you attend your in person appointment?" "What types of providers did you see?" Open-ended questions asking about time, "how long did it take?"

    Time frame: 12 months

  12. Cost to Institution - Clinic Costs

    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.

    Time frame: 12 months

  13. Cost to Institution - Team Costs

    Cost to Institution as assessed using Team Costs of Provider and Staff Training questionnaire. Multiple choice questions used to identify person being trained (e.g. role), "Doctor," "Nurse Practitioner," "Social Worker." Polar; Yes or No questions about provider and staff training for Team Clinic appointment; training on, "roles of the attendees," in Team Clinic. Issues regarding the study and study toolkit.

    Time frame: 12 months

  14. Cost to Institution

    Cost to Institution as assessed using the Feasibility and Usability of Toolkit questionnaire. Multiple choice questions used to identify the training session, role, provider, usability of toolkit, and training time. The questionnaire also includes a 6-point Likert scale: "Strongly disagree," "Somewhat Disagree," "Neutral," "Slightly Agree," "Somewhat Agree," and "Strongly Agree."

    Time frame: 12 months

  15. Clinical Efficiency

    Assessed using the Clinical Efficiency questionnaire which captures the number of patients seen during a given time period), team members seen, and time patients spent with team members.

    Time frame: 12 months

  16. Diabetes Strengths and Resilience Measure for Children

    DSTAR-Child assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  17. Diabetes Strengths and Resilience Measure for Teens

    DSTAR-Teen assesses adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes. It is a 12 item questionnaire using a 5 point Likert Scale format (1= Never, 2= Rarely, 3= Sometimes, 4= Often, 5= Almost Always). Items are scored on a scale of 12-60.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  18. PROMIS - Peds Peer Relationships

    Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Peer Relationships. Evaluates and monitors social health. Likert scale used to assess quality of relationships with friends and acquaintances. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  19. PROMIS - Peds Family Relationships

    Patient-Reported Outcomes Measurement Information System (PROMIS )- Peds Family Relationships. Evaluates and monitors social health. Likert scale used to assess the subjective (affective, emotional, cognitive) experience of being involved with one's family, feeling like an important person in the family, of feeling accepted and cared for, and feeling that family members, especially parents, can be trusted and depended on for help and understanding. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  20. PROMIS - Emotional Support

    Patient-Reported Outcomes Measurement Information System (PROMIS )- Emotional Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing perceived feelings of being cared for and valued as a person; having confidant relationships. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  21. PROMIS - Instrumental Support

    Patient-Reported Outcomes Measurement Information System (PROMIS )- Instrumental Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of assistance with material, cognitive or task performance. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  22. PROMIS - Informational Support

    Patient-Reported Outcomes Measurement Information System (PROMIS )- Informational Support (Parents/caregivers). Evaluates and monitors social health. Likert scale assessing Perceived availability of helpful information or advice.. (1= Never, 2= Almost Never, 3= Sometimes, 4=Often, 5= Almost Always)

    Time frame: At 0 (baseline) and 12 months (after visit 4)

Other outcomes

  1. Socio-Demographic History

    Self-reported demographic history (gender, age, race, household income, etc) will be collected.

    Time frame: At 0 (baseline)

  2. Medical History

    General health history via self report and EMR

    Time frame: 12 months

  3. Diabetes Treatment Regimen - glucometer

    Diabetes treatment regimen assessed through blood glucose checks per day from glucometer downloads will be collected from devices and EMR.

    Time frame: 12 months

  4. Diabetes Treatment Regimen - insulin pump

    Diabetes treatment regimen assessed through insulin boluses per day from insulin pump downloads will be collected from devices and EMR.

    Time frame: 12 months

  5. Diabetes Treatment Regimen - continuous glucose monitors

    Diabetes treatment regimen assessed through percentage of glucose values low, in target, or high for patients on continuous glucose monitors will be collected from devices and EMR.

    Time frame: 12 months

  6. Self-care and mobility as assessed using the EuroQOL five dimensions five levels youth (EQ-5D-Y) questionnaire

    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.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  7. The Child Health Utility

    The Child Health Utility 9 dimensions assesses health-related quality of life (HRQoL). Multiple choice used to capture respondents' endorsement of particular statements about experience. "I don't feel \[upset\] today," "I feel a little bit \[upset\] today," "I feel a bit \[upset\] today," "I feel quite \[upset\] today," "I feel very \[upset\] today"

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  8. Patient Health Questionnaire-8 (PHQ-8)

    Composed of 8 items to screen, diagnose, and measure the severity of depression.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  9. Shared Medical Appointments - Patient/AYA

    Likert scale; "Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments.

    Time frame: baseline to 12 months

  10. Shared Medical Appointments- Parent/caregiver

    Likert scale;"Strongly disagree" is 1, "disagree" is 2, "neutral" is 3, "agree" is 4, "strongly agree" is 5. Also, includes 3 open-ended questions to measures satisfaction for shared medical appointments.

    Time frame: baseline to 12 months

  11. Self Care - Related to Diabetes as assessed by Self-Care questionnaire

    Multiple Choice. Questions about diabetes related self care, "How many hours per day do you currently devote to managing your glucose levels?"

    Time frame: baseline to 12 months

  12. Diabetes Family Responsbility Questionnaire - Parent

    Asseses how adolescents with T1D and their families/caregivers share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  13. Diabetes Family Responsbility Questionnaire - Teen

    Asseses how parents/caregivers of children/teens living with T1D share diabetes management and responsibilities. 17 item questionnaire with a 3 factor solution. "Child" is 1, "equal" is 2, and "parent" is 3. A higher score indicates higher levels of caregiver/parent/family responsbility for diabetes management.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  14. Clinical Variables

    Polar; Yes or No questionnaire. Data extracted from EMR : cholesterol, high density lipoprotein, triglycerides, smoking status, nephropathy, microalbuminaria, macroalbuminaria, end-stage renal disease (death from end-stage renal disease), neuropathy, peripheral arterial disease (low extremity amputation), retinopathy (proliferative retinopathy), macular edema, blindness, angina, myocardial infarction, stroke, heart failure, revascularization (Coronary artery bypass grafting, PCA, and stenting). If answered "yes" for the following: ergosterol, HDL,microalbuminaria, and macroalbuminaria, values will be recorded.

    Time frame: At 0 (baseline) and 12 months (after visit 4)

  15. ADA and CCS standards

    EMR abstraction: Questions assess compliance with ADA and CCS standards when patients have contact with all team members annually. This will be noted with polar questions "Yes" or No." This will be tracked for all patients in the study (e.g., Team Clinic and Standard Clinic).

    Time frame: 12 months

  16. Single Item Literacy Scale

    Literacy assessed using the Single Item Literacy Scale. Multiple choice question asking about suppoort needed with reading materials. Options, "never," "rarely," "sometimes," "often," "always"

    Time frame: At 0 (Baseline) and 12 months (after visit 4)

  17. Provider Centered Care Observation Form (PCOF)

    Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintain Relationship Throughout the Visit," "Collaborative upfront agenda setting," "Maintain Efficiency using transparent thinking and respectful interruption," "Gathering information," "Assessing patient or family perspective on health," "Electronic Medical Record Use," "Physical Exam"

    Time frame: 12 months

  18. Facilitator Centered Care Observation Form (PCOF)

    Assessing the fidelity of care delivery for ensuring that patients receive full benefits of the Team Clinic intervetion. Domain checklist, "Establishes Rapport," "Maintains Relationship Trhoughout the Visit," "Session Introduction and Icebreaker," "Session Preparation," "Gathering Information," "Assessing Patient or Family Persepctive on Health/Understanding Context," "Blood Glucose Charting," "Blood Glucose Discussion," "Activity Kit Review"

    Time frame: 12 months

  19. Provider/Facilitator Session Feedback Form:

    Assess provider experience during clinic visit and patient-center delivery. Multiple choice, "Establishing Rapport and Maintaining Relationship," "Agenda-setting, Thinking Out-Loud, and Collaboration," "Gathering Information and Understanding Context," "EMR Review and Physical Exam," "Promoting Behavior Change or Self-Management," "Collaborative Planning and Closure," "None of these"

    Time frame: 12 months

07

Study locations

1 site
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
08

References and documents

Publications

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  • Willi SM, Miller KM, DiMeglio LA, Klingensmith GJ, Simmons JH, Tamborlane WV, Nadeau KJ, Kittelsrud JM, Huckfeldt P, Beck RW, Lipman TH; T1D Exchange Clinic Network. Racial-ethnic disparities in management and outcomes among children with type 1 diabetes. Pediatrics. 2015 Mar;135(3):424-34. doi: 10.1542/peds.2014-1774. PubMed 25687140 ↗
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  • Continous Glucose Monitoring (CGM) as a CCS/GHPP Program Benefit [press release]. 3/6/2017.
  • American Diabetes Association. Erratum. Glycemic Targets. Sec. 6. In Standards of Medical Care in Diabetes-2017. Diabetes Care 2017;40(Suppl. 1);S48-S56. Diabetes Care. 2017 Jul;40(7):985. doi: 10.2337/dc17-er07a. Epub 2017 May 18. No abstract available. PubMed 28522557 ↗
  • Winkley K, Ismail K, Landau S, Eisler I. Psychological interventions to improve glycaemic control in patients with type 1 diabetes: systematic review and meta-analysis of randomised controlled trials. BMJ. 2006 Jul 8;333(7558):65. doi: 10.1136/bmj.38874.652569.55. Epub 2006 Jun 27. PubMed 16803942 ↗
  • Kahana S, Drotar D, Frazier T. Meta-analysis of psychological interventions to promote adherence to treatment in pediatric chronic health conditions. J Pediatr Psychol. 2008 Jul;33(6):590-611. doi: 10.1093/jpepsy/jsm128. Epub 2008 Jan 11. PubMed 18192300 ↗
  • Hilliard ME, Harris MA, Weissberg-Benchell J. Diabetes resilience: a model of risk and protection in type 1 diabetes. Curr Diab Rep. 2012 Dec;12(6):739-48. doi: 10.1007/s11892-012-0314-3. PubMed 22956459 ↗
  • Rubin RY-H, D; Peyrot, M. Parent-child responsibility and conflict in diabetes care (Abstract) Diabetes Care. 1989;38:28A.
  • Palladino DK, Helgeson VS. Friends or foes? A review of peer influence on self-care and glycemic control in adolescents with type 1 diabetes. J Pediatr Psychol. 2012 Jun;37(5):591-603. doi: 10.1093/jpepsy/jss009. Epub 2012 Mar 29. PubMed 22460759 ↗
  • Chiang JL, Kirkman MS, Laffel LM, Peters AL; Type 1 Diabetes Sourcebook Authors. Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care. 2014 Jul;37(7):2034-54. doi: 10.2337/dc14-1140. No abstract available. PubMed 24935775 ↗
  • Salvy SJ, Ruelas V, Majidi S, Thomas A, Ashwal G, Reid M, Fox DS, McClain S, Raymond JK. Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes. Contemp Clin Trials. 2020 Aug;95:106079. doi: 10.1016/j.cct.2020.106079. Epub 2020 Jul 4. PubMed 32634486 ↗

Individual participant data

Plan to share: Yes — Development, execution, and data collection for this study is completed with a Principle Investigator at Children's Hospital Los Angeles. With documented permission of the IRB, a PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified investigators. Interested Investigators will complete a request form stating the aims of their analyses, analytic plan, available resources for completing a project, timeline, and goals (i.e. manuscripts or grant applications). The PIs and their research team will review requests to determine whether the analyses constitute an innovative exploration of the data, whether the team has resources to complete the request, and whether data will be adequately protected and managed. If issues arise, the PIs and research team will negotiate a fair resolution with interested investigators and NIH staff.

Supporting information: Study protocol, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04190368
Lead sponsor
Children's Hospital Los Angeles
Collaborators
University of Southern California, Cedars-Sinai Medical Center
Responsible party
jennifer raymond (MD, MCR, Associate Professor of Clinical Pediatrics, Clinical Director of Diabetes Center for Endocrinology, Diabetes, and Metabolism, Vice Chair of the Executive Telehealth Committee, Children's Hospital Los Angeles) — Principal investigator
First posted
Dec 9, 2019
Start date
Sep 7, 2021
Primary completion
Aug 31, 2024
Completion
Nov 30, 2024
Last update
Apr 4, 2025

Study contacts

Jennifer K Raymond, MD, MCR
principal investigator · Children's Hospital Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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